Job Opportunitie At Switzerland For Quality Department At Bristol Myers Squibb

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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 .

You will be responsible for ensuring the implementation and maintenance of a quality management system (QMS) to achieve GDP compliance with regulatory standards.

Key Responsibilities

Quality Oversight:

• Support the quality oversight of storage service providers (ex-US).
• Contribute to the maintenance, update, and revision of controlled documents (SOPs, WIs, etc.) owned by Distribution Quality.
• Act as the GDP review responsible reviewer for GDP space (delegation possible).
• Collaborate with Global GDS (Market Supply Operations) for strategy and review/approve GDP-relevant documents

Support and Contribution:

• Maintain the Distribution Quality Systems Quality Manual.
• Manage the lifecycle of SCQ customer complaints.
• Conduct periodic self-inspections according to the self-inspection plan and implement necessary corrective measures.
• Implement Deviation and CAPA management.
• Implement Change Control management.
• Review Quality Agreements with external partners and internal functions.
• Oversee the CLS Customer Qualification process.
• Support CLS inspections by Health Authorities.
• Conduct internal and external GDP training.

Subject Matter Expertise:

• Act as a global GDP SME, providing guidance and advice to key stakeholders as requested.
• Serve as an SAP user and backup for CLS quality activities related to inventory stored in Swiss DCs (e.g., FIEGE).
• Support IT validation activities by participating in UAT exercises (script runs) for quality tasks and act as an ALM user as needed.
• Establish global GDP standards as a quality partner.
• Review and approve technical qualification protocols and reports for storage activities.

Quality Operations Implementation:

• Oversee vendor/supplier management, including Quality Agreements, approval of subcontracted activities impacting product quality, and evaluation of supplier qualification status.
• Conduct periodic vendor/supplier license verification as per BMS procedures.
• Handle compliance/quality events within the SCQ team.
• Attend Market Action meetings as needed and support the characterization of adequate action plans within the market.
• Support any market action operations, including recalls for medicinal products and mock recalls.

Quality Risk Management:

• Coordinate and prepare Quality Risk Management activities.
• Participate in periodic Business Reviews with the DC.

Distribution Quality Organization:

• Communicate activities efficiently using the team's processes.
• Ensure full coverage (e.g., vacations, prioritization) through deputation as agreed.

Local Process Owner:

• Act as the SCIMQ LPO for Warehousing Strategy & Warehousing Support Execution.

Disclaimer: The responsibilities listed above are a summary and other responsibilities may be assigned as required.

Expected area of competence:

• Good knowledge in GDPs and/or cGMPs regulations promulgated by the FDA, EMA or equivalent regulatory Agencies and requirements for pharmaceutical products storage and distribution
• Ability to multitask and manage multiple deliverables and projects at the same time (agility) under supervision
• Good knowledge of industry standard Quality and Compliance methodology to ensure they meet the regulatory requirements.
• Can act as quality liaison for projects with GDP/GMP impact within SCIMQ and stakeholders
• Ability to work in a team environment, effectively interacting with others
• Must be results oriented, and demonstrate a simplification knowledge
• Excellent communication and presentation skills, with the ability to convey complex information to diverse audiences
• Ability to work independently and prioritize tasks effectively in a fast-paced environment
• Demonstrated innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities
• Demonstrated ability to work in a matrixed organization with diverse teams and to influence areas not under direct control
• Fluent in English

• Decision making:
• Involved in executing company-controlled documentation (SOP, WIs, FRM, etc.) that affect immediate operations and may have company-wide effect
• Works on problems and unplanned event under supervision
• Exercises judgement within defined practices and policies in selecting methods, techniques and (a plus) evaluation criteria

• Ability to develop and apply BMS operating philosophy and to operate within Company policies and procedures within Quality and Compliance area.
• Good verbal, written and presentation skills in English.
• Team oriented with good interpersonal skills.
• Ability to participate in projects within a multi-disciplinary environment, inquisitive, science technology oriented individual but practical.

Qualifications & Experience:

• 3-5 years of progressive experience within the quality function of the pharmaceutical health care industry.
• Knowledge and experience in pharmaceutical health care operations, quality assurance, distribution and international regulations are essential.
• Proficient in GDPs and regulations promulgated by the FDA, EMA or equivalent regulatory Agencies, and requirements for pharmaceutical products distribution.
• Demonstrated experience in international Quality Operations activities with markets

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.

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