Pharmacovigilance Quality Assurance Lead

Zoetis Zaventem, Belgium

As the Pharmacovigilance Quality Assurance Team Lead within the Regulatory Affairs, Global Quality & Compliance (GQC) group, oversee the Quality Assurance (QA) PV program for Zoetis. Continuously develop and drive the strategy for quality and regulatory compliance within the program. Within this role, instill a philosophy of risk balance, consistency and efficiency within the Zoetis community, Global Pharmacovigilance, and other stakeholders of the company.

• As a leader within the GQC group, provide quality assurance oversight to the global PV program;
• Be the point of contact for pharmacovigilance QA, ensuring alignment and open communication with US and European Pharmacovigilance teams and other stakeholders of the program;
• Lead the day-to-day GQC PV operational activities including the scheduling of GQC PV auditing activities (process audits, distributor and Zoetis Country Office audits);
• Be proficient in performing pharmacovigilance quality assurance audits and inspections of Veterinary Medicine Research & Development (VMRD) PV processes as well as those PV processes which reside outside the VMRD organization (e.g., country offices, distributors);
• Take a lead QA role in the management of CAPA and deviation activities for pharmacovigilance operations;
• Participate in government inspections of the pharmacovigilance program and others types of inspections as requested;
• Provide advice on regulatory and corporate compliance, as well as provide evaluations of current practices that may need improvements. Provide novel approaches to increasing effectiveness of both the GQC group and the quality and compliance of VMRD. Interact effectively with VMRD managers and their staff as an advisor on the interpretation of compliance aspects;
• Supervise GQC colleagues and contractors who participate in PV audits. Be responsible for meeting company driven deadlines for conducting performance evaluations, colleague development planning, and other required supervisory roles;
• Assist the GQC Global Lead with budgetary planning and monitoring activities;
• Where appropriate, assist with staff recruitment and training;
• Participate in a variety of quality assurance-related activities including staff and project meetings, non-research study document reviews, and consultations with VMRD colleagues;
• Take a lead role in participating in VMRD meetings, specifically GQC PV meetings, projects and ad hoc committees for quality initiatives;
• Communicate (verbal and written) well with VMRD colleagues, management level individuals, and external parties (e.g., distributors, CROs, vendors). Ability to effectively represent the company or the GQC group in external-facing situations.

EDUCATIONAL BACKGROUND/EXPERIENCE

MINIMUM:

• Bachelor’s Degree or equivalent in biology, animal science or other relevant science field.

DESIRABLE:

• Master’s degree or equivalent in biology, animal science or other relevant science field.

WORKS EXPERIENCE/SKILLS

MINIMUM:

• Demonstrated relevant auditing experience (minimum 5 years) in veterinary pharmacovigilance or related regulatory environment;
• Experience with deviation/CAPA processes and associated documentation;
• Experience in managing people;
• High level of competency using Microsoft Office suite (e.g., Word, Excel, Outlook);
• Establishment of excellent interpersonal relations; good communications; ability to negotiate, risk assess, and problem-solve;
• Ability to work independently, while fostering good working relationships across physical distance and have flexibility and the capacity to handle multiple tasks at once;
• Ability to travel, if needed.

Senior/Principal Microbiologist

Eli Lilly Benelux Limerick, Ireland

Responsibilities:

We are seeking a Senior/Principal Analytical Microbiologist to support our new Biologics Manufacturing Facility at Raheen Co. Limerick. The Senior/Principal Analytical Microbiologist role in the Quality Control area provides the analytical technical leadership for all aspects of microbiological technologies and methods.

This role will be responsible for provision of analytical methods, data and information using analytical techniques in supporting site manufacturing processes and projects. The development, technical transfer and validation of the methods and their associated lifecycle will be a key aspect of this role.

The lifecycle management of existing technologies and instrumentation will be a further aspect of this role. This role will be responsible for all the information generated that will be used to support manufacturing objectives, across regulatory submissions and supply chain. The active participation in cross functional teams within the internal manufacturing sites and development will be required to understand manufacturing and regulatory requirements while also providing the analytical technical leadership and perspective to meet the manufacturing goals

• Support the introduction, validation and on-going technical agenda for pipeline and commercial analytical methods and technology.
• Ensure methods are scientifically robust with the required performance attributes to satisfy stakeholder needs.
• Execute and/or oversee testing protocols in accordance with local procedure and regulatory requirements.
• Develop strong links with Global Regulatory Affairs and participate in the preparation and review of regulatory submissions.
• Provide training and mentorship to QC team members and cross functionally.
• Act as SME for one or more technologies and/or business systems within QC. This will include the identification, sourcing, installation, and qualification of new equipment.
• Assure that all raw materials, utilities, including environmental, in-process samples or final products are appropriately analyzed and authorised. In the event of non-conformance to acceptable quality and/or safety standards, lead analytical investigations, using Root Cause Analysis techniques where appropriate. Ensure all associated countermeasures are complete. Work with onsite technical teams to improve the state of validation and drive analytical variability reduction.
• Support the writing of Annual Product Reviews (APRs) on Active Pharmaceutical Ingredients and Laboratory Periodic Review Reports (PRRs).
• Support and participate in self inspection or other audits with particular reference to the analytical aspects of cGMPs as defined by the Health Authorities, Food and Drug Administration, etc.
• Proactively support management decisions and strategy and be a role model for Quality Control team members in terms of performance and behaviors.
• Influence the business/external partners on critical issues to meet end goals – understand the external context/environment to achieve these goals.

Basic Requirements:

• BSc (Hons)/MSc/PhD Analytical Sciences (Chemistry, Biochemistry, Microbiology) with a minimum of 5 years pharmaceutical experience.