At a Glance
- Tasks: Lead global pharmacovigilance quality audits and enhance quality processes.
- Company: Join a leading pharmaceutical company focused on patient safety.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on continuous improvement.
- Why this job: Make a real impact in drug safety and quality assurance.
- Qualifications: Experience in pharmacovigilance quality assurance and strong communication skills.
The predicted salary is between 60000 - 80000 £ per year.
This role is a member of the GVP QA team providing global PV Quality Assurance oversight of Alnylam’s post‑marketing pharmacovigilance system, with a focus on PV audit execution, vendor quality oversight, CAPA management, and PSMF support. The role leads and executes the global PV audit program and partners cross‑functionally to strengthen PV quality processes. This position reports to the Associate Director, Global PV Quality Assurance and frequently interacts with cross‑functional teams. This role is hybrid, working 2 days per week based in either the Maidenhead, UK or Amsterdam, The Netherlands office.
Key Responsibilities
- Serve as a strong partner with Expertise Areas (EAs) in the enhancement of the global pharmacovigilance system through PV quality audits, risk‑based quality oversight, and continuous improvement of PV processes.
- 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).
- Support cross‑GxP QA activities requiring PV and PMS expertise.
- Lead and execute global PV quality audits for licensing partners, external PV vendors, internal functions, affiliates, and other applicable service providers in a post‑marketing environment.
- Determine, evaluate and investigate Quality Events, and assess adequacy of root‑cause analyses and CAPAs, applying risk‑based thinking to determine required actions.
- Effectively communicate and escalate critical matters to management.
- Own and drive the Global PV Strategic Audit Program, including development of risk‑based PV audit strategy, maintenance of the PV audit universe and risk tools, and creation of global PV audit plans and schedules.
- Determine, evaluate and investigate PV Quality Events, and own and drive root‑cause analysis, CAPA development, implementation, and effectiveness checks for PV audits and vendor oversight activities.
- Support the Global Strategic Audit Program – contribute to risk‑based audit strategy and maintain and enhance PV audit universe, risk tools and develop PV audit schedule.
- Own and execute PVQA contributions to the PV System Master File (PSMF), including compiling, maintaining and providing audit, CAPA and supplier quality information to ensure comprehensive and accurate PSMF content.
- Develop and maintain processes and tools to support quality audit execution and outcomes.
- Act as the primary operational PVQA owner and QA contact for global PV, PMS, and PV‑related vendors, including audit planning and execution, CAPA management, and ongoing vendor quality oversight.
- Develop and report GVP QA metrics and dashboards to support quality oversight.
- Develop and maintain GVP QA Training Plan; conduct PV and PMS training sessions for QA and EAs.
- Lead or contribute to Quality or PV and PMS initiatives, identify and propose process improvement opportunities and solutions.
- Other assignments as directed.
Qualifications
- Educated to university degree (preferably life sciences) or equivalent qualification or experience.
- Extensive experience in the pharmaceutical industry within global Pharmacovigilance Quality Assurance (PVQA), including PV audit execution and vendor quality oversight.
- Audit skills and experience of conducting GVP audits is preferred.
- Understanding of and working experience with international GVP regulations, FDA PV requirements, Health Authority guidance and ICH.
- Experience supporting Health Authority inspections.
- Self‑motivated with the ability to demonstrate initiative and internal drive for continuous improvement.
- Strong interpersonal, verbal and written communication skills, building positive and productive working relationships.
- Diplomatic in addressing sensitive issues confidentially and professionally, handling confidential information responsibly.
- Ability to analyse complex situations/issues and demonstrate strategic thinking.
Senior Manager, Quality Assurance (PVQA) employer: Alnylam Pharmaceuticals
Alnylam Pharmaceuticals is an exceptional employer, offering a dynamic work environment that fosters collaboration and innovation in the field of pharmacovigilance. With a hybrid working model based in Maidenhead or Amsterdam, employees benefit from a supportive culture that prioritises professional growth through comprehensive training and development opportunities. The company's commitment to quality assurance and continuous improvement ensures that team members are engaged in meaningful work that directly impacts patient safety and regulatory compliance.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, Quality Assurance (PVQA)
✨Tip Number 1
Network like a pro! Reach out to folks in the industry, especially those already working at Alnylam or similar companies. A friendly chat can open doors and give you insider info that could make your application stand out.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of pharmacovigilance and quality assurance processes. Be ready to discuss how you've tackled challenges in past roles, especially around CAPA management and audit execution.
✨Tip Number 3
Showcase your soft skills! Communication and relationship-building are key in this role. Think of examples where you've successfully collaborated with cross-functional teams or handled sensitive issues diplomatically.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you're genuinely interested in joining our team.
We think you need these skills to ace Senior Manager, Quality Assurance (PVQA)
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Manager, Quality Assurance role. Highlight your experience in pharmacovigilance and quality assurance, especially any relevant audits or CAPA management you've done. We want to see how your skills match what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in pharmacovigilance and how you can contribute to our team. Be sure to mention any specific experiences that relate to the key responsibilities listed in the job description.
Showcase Your Communication Skills:Since this role involves a lot of cross-functional interaction, make sure to demonstrate your strong communication skills in your application. Whether it's through your CV or cover letter, we want to see how you effectively convey complex information and build relationships.
Apply Through Our Website:Don't forget to apply through our website! It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it gives you a chance to explore more about StudySmarter and what we stand for.
How to prepare for a job interview at Alnylam Pharmaceuticals
✨Know Your Stuff
Make sure you brush up on your knowledge of pharmacovigilance and quality assurance. Familiarise yourself with the latest regulations and guidelines, especially those related to GVP and FDA requirements. This will not only show your expertise but also your commitment to staying updated in the field.
✨Showcase Your Experience
Prepare specific examples from your past roles that highlight your experience in PV audit execution and vendor quality oversight. Be ready to discuss how you've handled CAPA management and risk-based thinking in your previous positions. This will help demonstrate your practical skills and problem-solving abilities.
✨Communicate Effectively
Since this role involves cross-functional collaboration, practice articulating your thoughts clearly and concisely. Think about how you can convey complex information in a straightforward manner. Good communication skills are key, so be prepared to showcase your ability to build positive working relationships.
✨Ask Insightful Questions
Prepare thoughtful questions about the company's PV quality processes and the challenges they face. This shows your genuine interest in the role and helps you assess if the company is the right fit for you. Plus, it gives you a chance to engage with the interviewers and demonstrate your strategic thinking.
