This role is a member of the GVP QA team providing Quality oversight of Alnylam’s global post-marketing pharmacovigilance system, full application of EMA Good Pharmacovigilance Practices (GVP) Modules, and implementation of other worldwide PV regulations, and application of Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP). This includes support of the development and execution of the GVP audit program as well as contributing to Alnylam’s Inspection activities. The Associate Director PV QA will deputize for Director Global PV QA as needed.

This position reports to the Director, Global PV Quality Assurance and frequently interacts with external parties, and cross-functional teams. Interactions will also be with cross-QA management and cross-EA management as needed.

Summary of Key Responsibilities:

Associate Director, PV QA supports all the GVP QA responsibilities as listed below. Different members of the team will have particular focus areas. The Associate Director will lead specific activities and support the more junior members of team:

• Execute on global core auditing processes for licensing partners, external vendors, internal audits, affiliates, and other applicable service providers in a post-marketing environment.
• Lead activities related to the Global Strategic Audit Program. Define a risk-based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
• Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system, including ensuring compliance with GVP regulations.
• Partner and support EAs in ensuring conduct of non-interventional, observational, and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology Practice (GPP) and Good Post-marketing Study Practice (GPSP)
• Lead or contribute to cross-GxP QA activities, and cross-functional Quality or PV and PMS initiatives. Identify, propose and drive process improvement opportunities and solutions.
• Determine, evaluate and investigate Quality Events. Determine and influence adequacy of root cause analyses and CAPAs.  Applies risk-based thinking in determining required actions.
• Effectively communicate and escalate critical matters to management and monitor remediation actions.
• Attend and present at leadership and governance forums on behalf of GVP QA, as requested.
• Provide QA Audit, CAPA and Supplier data for the PV System Master File (PSMF). Develop and maintain efficient processes to ensure comprehensive and accurate data.
• Approve PSMF contributions on behalf of Director PV QA when required.
• Identify, develop and maintain processes and tools to support quality audit execution and outcomes.
• Determine, develop and report GVP QA metrics and dashboards to support quality oversight.
• Lead or support inspection management (IM) activities and contribute to IM strategies.
• Determine risk-based approach for Quality oversight of PV, PMS and PV-related vendors and commercial partners. This includes vendor notification, qualification or due diligence assessments, Quality Agreements, KQIs and audits.
• Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
• Providing development support and mentoring to more junior staff
• Other assignments as directed.

Requirements and skills

• Educated to university degree (preferably life sciences) or equivalent qualification or experience
• Extensive experience in the pharmaceutical industry in a quality or compliance function.
• Audit skills, and experience of leading GVP audits.
• Experience supporting Health Agency inspections and leading some inspection activities.
• Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidances and ICH.
• Self-motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
• Strong interpersonal, verbal, and written communication skills. Builds positive and productive working relationships.
• Significant experience in Quality role, demonstrating leadership
• Ability to anticipate business risks, GVP compliance issues, and quality related challenges while being solution oriented.

About Alnylam: Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by “interfering” with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.