Senior Director of Pharmacovigilance QA / Quality Assurance Leader in Drug Safety
Location
Bridgewater, NJ | United States
Job description
Join my client, a global biopharmaceutical company, in transforming the lives of patients with serious and rare diseases. As the Senior Director of Pharmacovigilance QA, you will play a pivotal role in managing quality and regulatory compliance, ensuring adherence to Good Pharmacovigilance Practices (GVP) and related activities. This is an opportunity to make a significant impact on patient well-being by fostering collaboration and maintaining a high standard of quality.
Why You Should Apply:
- Shape the Future: Be a key strategic partner in shaping the direction of drug safety and pharmacovigilance practices globally.
- Top Employer: Join a company consistently recognized as a top employer in the biopharma industry, fostering a collaborative and inclusive work environment.
- Innovation Focus: Contribute to innovative solutions for patients, translating passion for science and research into impactful outcomes.
- Global Impact: Work with a diverse and talented team from around the world, addressing critical healthcare needs.
What You'll Be Doing:
- Risk-Based Quality System: Facilitate and maintain a risk-based quality system supporting GVP.
- Inspection Readiness: Establish and maintain Pharmacovigilance inspection readiness, representing the company during regulatory agency inspections.
- Audit Expertise: Develop and implement a risk-based audit plan, conduct internal and external audits on PV vendors, and contribute to the evaluation of Pharmacovigilance vendors.
About You:
- Be able to do the job as described.
- 10-15 years of pharmaceutical industry experience with 7-10 supporting pharmacovigilance
- Experience with effectively managing regulatory agency inspections.
- Strong knowledge of FDA, EU, and ICH regulations, pharmacovigilance processes, and risk-based quality systems.
- Demonstrate hands-on leadership and cross-functional collaboration.
- Ability to organize and conduct internal and external audits on PV vendors and organizations.
- Advanced degree, or Bachelor's degree with additional experience.
- Ability to travel and work onsite periodically.
How To Apply: We'd love to hear from you! Send an email to [email protected] and share why you're interested. If you have a resume ready, apply here.
Join us in accelerating your career while making a difference in patients' lives. Be part of a company that values collaboration, accountability, passion, respect, and integrity.
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