We are currently looking for an experienced Quality Specialists (Leads) to be based in Lithuania

Our Quality Leads support the continuous improvement of key components of the Quality Management System (QMS) and related standards. Work with QMSO leadership to assess and report on the functioning of components constituting the QMS.

Knowledge and Experience :

• Extensive experience in a Clinical Research field (pharmaceutical industry or CRO) or other relevant experience in the areas of QMS support required
• Knowledge of Good Practices (GxP) compliance required
• Project Management / Technology / Business Operations experience, as appropriate, preferred
• English proficiency (written and oral)

Skills:

• Good interpersonal, verbal and written communication skills including effective listening, facilitating group discussions, influencing without authority and providing appropriate feedback.
• Ability to plan, organize, prioritize and manage workload with LM guidance, keeping the patient and client at the focus.
• Quality oriented with an attention to detail, taking initiative, ownership and accountability for deliverables
• Cultural awareness with the ability to think and work, globally

Education:

• Bachelor’s Degree is required (Life-science, health or industry-related discipline preferred)

Apply Here

With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermo-cosmetics, and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body’s largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we’re in shapes our lives, we are advancing dermatology for every skin story.

We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.

At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.

Further supporting our growth and innovation momentum, we are establishing a new Global Capability Center in Barcelona to deploy new capabilities to effectively support its global commercial and functional teams. Located in the upscale Eixample District in the heart of Barcelona, Galderma’s Global Capability Center offers numerous possibilities for professional development such as exposure to global and cross-functional projects and access to global career opportunities.

Job Title: Head of Global Quality System

Location: Barcelona

Job Description

As part of the Operations and Commerical Quality, this role will establish (for new entities), maintain and develop Galderma's Global Quality Management System ensuring that Galderma's Policies and procedure remain compliant with the relevant government regulations according to the product applicable classification : cGMP, GDP, ISO, cGMP, GDP, ISO, Medical Devices regulations or any other relevant regulations and guidance and guidance. This position will ensure that appropriate personnel are properly and efficiently trained as per requirements.

Key Responsibilities

The incumbent will manage Global Quality System topics for Galderma in collaboration with his/her manager on the following responsibilities:

• Manage with the relevant stakeholders, the creation and revision of the Global Documents (including Quality Policies, Global SOPs, and Guidelines, etc.) which support an end-to-end management of the quality processes
  
• Establish (for new entities), maintain, and develop Galderma's global Quality Management System through the electronic Quality Management System (eQMS) and the electronic Document Management System (eDMS) while ensuring compliance with the government regulations. Ensures the qualification status of these tools is kept current.
  
• Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate training plans for the teams using our global Learning Management System (gLMS). Ensures the qualification status of this tools is kept current.
  
• Establish, develop, and maintain in collaboration with relevant stakeholders and Managers the appropriate Quality KPIs, targets and reporting ensuring an ongoing monitoring of the quality processes performance.
  
• Develop, maintain and improve templates for Quality KPI Dashboards, Quality Management Reviews and participates in Global Quality Reviews (preparation and presentation as needed)
  
• Prepare, manage and maintain an annual audit program ensuring vendors oversight in the areas of cGMP, GDP, ISO, Medical Devices regulations. Ensure the attainment of the annual audit plan. Ensure the auditor qualification program while maintaining enough qualified auditors.
  
• Ensure a regulatory surveillance of the evolution of the applicable government regulations (including cGMP, GDP, ISO, Medical Devices regulations or any other relevant regulations and guidance and guidance)
  

Skills & Qualifications

• Background in Medical Device, pharmaceutical or biopharmaceutical industry.
  
• A demonstrated knowledge and execution of Quality System Management.
  
• Knowledge of electronic training management systems
  
• Knowledge of different regulations:
  
  • Medical Device applicable regulation (NF EN ISO 13485; CMDCAS; directive 93/42/EC; 21 CFR 820, ...).
    
  • GMP (FDA, EU, ICH, PICs regulations, cGMPs related to all major territories),
    
  • GDP regulatory requirements.
    
• Solid background in MS-Office suite and other IS tools.
  

What we offer in return

• You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base.
  
• You will receive a competitive compensation package with bonus structure and extended benefit package.
  
• You will be able to work in a hybrid work culture.
  
• You will participate in feedback Loops, during which a personalized career path will be established.
  
• You will be joining a growing company that believes in ownership from day one where everyone is empowered to grow and to take on accountability
  

Process steps

• Send your CV in English.
  

• If your profile is a match, we will invite you for a first virtual conversation with Talent Acquisition.
  
• The next step is a virtual conversation with the hiring manager.
  
• The final step is a panel conversation with the extended team.
  

Our people make a difference

At Galderma, you’ll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us .

Qualifications & Experience

• Bachelor's degree in science, or a closely related field.
• 10+ years of experience in a pharmaceutical/ biopharmaceutical/Advanced Therapeutic Modality Products (ATMP) environment including 7+ yrs previous Supplier/Vendor Quality mgmt leadership position and 5+ yrs managing/leading teams. ATMP experience a plus.
• Expertise in GMP compliance, Quality System and global GMP regulations; must also have strong knowledge and experience with Quality Risk Management.
• Strong understanding of supplier management principles, governance frameworks, and performance metrics.
• Strong analytical and problem-solving skills, with the ability to analyze supplier data, assess risks, identify trends, and develop mitigation strategies and improvement opportunities.
• Strong leadership and stakeholder management skills, with the ability to influence and collaborate effectively with cross-functional teams.
• Demonstrated Strategic Agility through anticipation of future trends and consequences, and adjustment of strategies accordingly.
• Demonstrated influential leadership expertise and experience with senior level interactions.
• Demonstrated Enterprise mindset to be able to think and act across functions and divisions.
• Demonstrated ability to wield and develop technologies, innovations, programs, and procedures that move the business forward.
• Demonstrated and perceived ability to lead, develop and instill confidence through the reinforcement of teamwork and exemplification of BMS values.
• Excellent communication and presentation skills, with the ability to convey complex information to diverse audiences.
• Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.

Key Responsibilities

• In partnership with the Senior Director, Supplier Quality Excellence, Global Supplier Compliance Leads and the Vendor & Materials Mgmt. Global Process Lead & Systems Lead, Support the development and implementation of a comprehensive quality management program for supplier lifecycle management inclusive of risk-based oversight models, ongoing strategy and continuous improvement and ensuring compliance with regulatory requirements.
• Lead the cross-functional collaboration with BMS Site, Procurement, Supply Chain and Material Science teams to ensure holistic understanding of supplier performance across the BMS GPS operating units to inform and drive the strategy for enhanced supplier performance supporting business drivers and optimizing value.
• Proactively identify supply risks and create and execute strategies to avoid or minimize their impact.
• Co-chair internal and supplier specific quality governance and oversight forums, as required.
• Responsible for the management and coordination of activities related to the governance framework including process alignment with evolving regulations, and development and maintenance of global procedural documents and training materials.
• In partnership with the SD, Supplier Quality Excellence, develop and implement transformational strategy of real-time assessment of supplier performance and predictive indicators which will enable preventive actions to enhance operational performance.
• Provide direction and critical input in setting, monitoring, and analyzing globally aligned metrics, key performance indicators/key quality indicators across the VMM QMS and Supplier LCM for applicable BMS quality councils and supplier quality steering committees.
• Work horizontally across QMS, Procurement and Site teams to analyze and integrate metrics data across GxP for review and actioning with appropriate risk mitigation strategies centered on health of the QMS, products in development and in commercial supply.
• Oversee the development and maintain Quality Performance dashboards in partnership with Predictive Quality Governance & Performance Mgmt, BI&A, GPS Strategic Sourcing & Procurement (GPS SSP) and site quality teams for VMM QMS Health & Maturity management, Supplier Quality global KQI/KPIs and individual supplier KQI/KPI to ensure real-time visibility of QMS and Supplier LCM performance, driving accountability and actions.
• Oversee the development and implementation of improved mechanisms for metric monitoring, analysis, trending, and reporting with innovative data analytics and technology solutions.
• Promote and enable a culture of psychological safety, inclusion, and diversity.
• Champion an Enterprise-wide Quality mindset / Culture of Quality

Other Responsibilities:

• Support Health Authority inspections and audits of BMS sites/functions, act as QA representative (SME) for functional area relevant topics.
• Lead and/or participate as QA representative to internal work streams, projects, and improvement initiatives.
• Participate in external trade organizations and external programs to represent BMS in the development of industry-wide Supplier Quality Mgmt. health and maturity programs.

#BMSBL

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science™ , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol

BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ eeo -accessibility to access our complete Equal Employment Opportunity statement.

BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: 

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Within this role you will be responsible to specialize in developing new QC microbiology test methods; providing critical microbiology support to cell-culture, manufacturing (drug substance and drug product), and facilities. This position may be actively involved in Alternative and Rapid Technologies associated with Microbiological Assays. Ensure departmental compliance to regulatory guidelines are maintained. Drives continuous improvements for microbiological methods.

This is a 12-month temporary contract

As a QC Micro Specialist, a typical day might include, but is not limited to, the following:

• Identifying, introducing, onboarding and initially qualifying alternative and rapid technologies applicable to microbiological assays and procedures, becoming the SMEs of these technologies, assays, and procedures
• Leading Test Method validations, studies and assisting in troubleshooting efforts (Investigations). These include test methods transferred or developed at CMO/CLOs. All these efforts may gain complexity over time
• Applying a fundamental understanding of the science behind the microbiological assays to perform advanced troubleshooting and complete complex microbiological investigations
• Assisting in the building of processes where gaps have been identified
• Leading tasks associated with aseptic process simulations
• Collaborating with team members on activities associated with Change Control. This includes initiating, impacting, and implementing the change; also initiating and closing workflows and CAPAs
• Participating in the writing of technical documents and studies to troubleshoot and support investigations
• Applying their expertise in the creating and updating of SOPs
• Leading data gathering and analysis in support of investigations and business decision-making
• Leading the evaluation of data entry, analysis, and reporting of microbiological data and supporting the implementation of changes to identify streamlining opportunities
• Suggesting alternative solutions/workarounds while obtaining buy-in from the organization
• Participating in internal audit discussions and seeking alignment with the team to address microbial requests
• Collaborating in technical discussions and problem-solving with outside entities (i.e., contract manufacturers and contract test labs) to drive resolutions
• Assisting in effectively communicating technical solutions to others in the organization
• Seeking support to make good judgments and quick decisions regarding microbiological methods
• Assisting in the integration of technical updates into team procedures while maintaining compliance with regulatory agencies
• Staying current with industry trends in QC technology
• Implementing the creation and review of LIMS configurations to meet the needs of QC-Microbiology, this may include implementing new specifications, designing LIMS/ELN templates for new/revised test methods, designing queries, and reporting
• Assisting in the collection and maintenance of reference libraries for microbiological methods
• Assisting others across all aspects of the team, may manage others through influence rather than direct authority

This role might be for you if :

• You are a facilitator with organizational agility
• You can assist in the development and support of strategies on how to achieve what needs to be done and develops metrics to measure the strategy
• You have advance knowledge in Microbiological Test Methods (This includes, but is not limited to: Endotoxin, Low Endotoxin Recovery, Bioburden, Sterility) associated with Drug Substance, Drug Product; Gene Therapy, Raw Materials, Utilities and Disinfectants
• You have excellent written, verbal and interpersonal communication skills
• You have the ability to effectively interact with all levels both within and outside the company
• You can resolve and negotiate conflicts or problems with tact, diplomacy and composure
• You have the ability to handle multiple priorities with exceptional organizational and time management skills
• You are proficient in IOPS Systems (e.g. BMRAM, Discoverant, Documentation Compliance, LIMS, Microsoft Word, Microsoft Excel, Process Compliance)

To be considered for this opportunity you should have a BS/BA microbiology with at least 2 years of relevant experience or equivalent combination of education and experience.

#REGNIELSM #LI-Onsite #IRELIM #JOBSIEST #REGNIEEC

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.