Senior Manager, Pharmacovigilance Quality Assurance, R&D Quality and Compliance

Moderna

Warsaw, Poland

The Role:

Reporting to the Director of Pharmacovigilance Quality Assurance (PVQA), Research & Development Quality and Compliance (RDQ&C), the Senior Manager, PVQA, plays a key role in strengthening Moderna’s pharmacovigilance quality function in the region. This position provides strategic oversight of PV quality systems, audits, and inspections while ensuring compliance with global and regional regulatory requirements.

The role involves close collaboration with Moderna’s Clinical Safety and Pharmacovigilance (CSPV) organization, Global Regulatory Science (GRS), Global Medical Affairs (GMA), and local affiliates, ensuring consistent implementation of quality standards, regulatory requirements, and compliance-related initiatives. The individual will lead complex pharmacovigilance audits, support regulatory inspections across EMEA, and contribute to CAPA and issue management processes.

This position requires an experienced PV quality professional with a strong auditing background, the ability to influence at multiple levels of the organization, and a proactive approach to quality risk management.

Here’s What You’ll Do:

Provide expert PV quality assurance guidance and support to internal stakeholders, ensuring compliance with global pharmacovigilance regulations and best practices.
Plan, conduct, and report on risk-based pharmacovigilance audits of Moderna affiliates, global PV systems, vendors, and business partners.
Ensure Moderna affiliates and functions are fully prepared for GVP regulatory inspections, providing strategic support before, during, and after inspections.
Ensure end-to-end PV audit activities are timely and compliant.
Provide strategic input to the planning and risk-assessment for the global PV audit program (e.g., vendor, system, affiliate, & partner audits).
Oversee CAPA development, execution, closure and, as needed, escalation for CAPAs associated or impacting pharmacovigilance.
Provide input into the R&D issue management impacting the local and global PV system to ensure early detection of issues, development of corrective and preventative actions (CAPA), tracking of CAPA completion, and assessment of effectiveness.
Identify and implement process enhancements to strengthen the PVQA department oversight and ensure regulatory expectations are met.
Remain current with industry trends and draft regulations/guidance.
Participate in ad-hoc RDQ&C compliance projects and initiatives.
Contribute to the continuing development of a quality culture at Moderna.
Approximately 50% of time is spent in the audit role.
Approximately up to 30% travel required.

Here’s What You’ll Bring to the Table:

BS/BA (10+ years), MS (8+ years), or PhD (7+ years) in Life Sciences, Pharmacy, or a related field.
Extensive experience in pharmacovigilance operations and/or GVP Quality Assurance within a global biotech, pharmaceutical, or CRO environment.
In-depth knowledge of relevant FDA, EMA, pharmacovigilance guidelines, and local/regional GVP regulations.
Hands-on experience of planning, leading, and reporting on global pharmacovigilance audits.
Experienced in CAPA management and issue resolution.
Working knowledge of relevant FDA, EU, ICH Pharmacovigilance guidelines and regulations preferred.
Experience working with CROs, vendors, and relationship management preferred.
Excellent auditing skills and ability to communicate significant observations to internal and external stakeholders in a sound and factual manner.
Strong interpersonal skills and ability to provide training and mentoring to auditor trainees and junior staff.
Strong leadership skills with ability to effectively organize and execute tasks.
Ability to work both independently and in a team environment.
Excellent communication and presentation skills, both verbal and written.
Ability to influence and negotiate effective solutions, excellent interpersonal skills.
Ability to manage multiple projects in a fast-paced environment.
Ability to collaborate effectively in a dynamic, cross-functional matrix environment.