Director of Quality Assurance and Pharmacovigilance

4 days ago

Waltham, Massachusetts, United States Alkermes, Inc. Full time

Job Summary:

The Director of Quality Assurance and Pharmacovigilance is a key leadership position responsible for overseeing the Clinical Quality Assurance Department at Alkermes, Inc. This role plays a critical part in ensuring the quality and integrity of post-marketing pharmacovigilance practices and commercial operations that contribute to the company's safety data.

Main Responsibilities:

  • Develop and Implement Quality Strategies: Develop risk-based and current industry-standard annual audit planning, focusing on incoming safety data from all sources, compliant case processing and reporting, medical review, signal detection, risk management programs, and safety-related labeling.
  • Conduct and Manage Quality Audits: Schedule, personally conduct, and/or manage quality audits for Good Pharmacovigilance Practices (GPvP), Commercial Safety, and Prescription Drug Marketing Act (PDMA) activities.
  • Build and Manage Resources: Build and manage internal and external resources for quality audits and ongoing departmental oversight and partnerships.
  • Regulatory Expertise: Serve as a key opinion leader for GPvP and PDMA regulations, process strategies, and regulatory guidelines (domestic and international) for all related departments.
  • Collaboration and Partnership Building: Collaborate and enhance partnerships with all departments to obtain optimal GPvP and PDMA education, training, compliance, and inspection readiness.
  • Audit Oversight: Provide oversight for and participate in audits of clinical safety and PV vendors, PV partners, electronic clinical and PV data systems, clinical and post-marketing PV documents.
  • Management Oversight: Provide management oversight for and participate in internal systems audits relevant to safety data and regulatory reporting and sample management.
  • Training and Development: Provide supervisory support, mentorship, and training to auditors and contract auditors.
  • Quality Assurance and Compliance: Provide quality assurance and compliance status of the company's Pharmacovigilance and PDMA systems to management and senior management.
  • Vendor Management: Assist in vendor selection, audit qualifications, oversight, and risk-based auditing of third parties supporting GPvP.
  • Follow-up and Resolution: Collaborate with the Drug Safety group in follow-up to internal, vendor, specialty pharmacy, and partner audits to ensure resolution of audit findings.
  • Metrics and Risk Management: Assist with the maintenance of tracking systems for all GCP/GPvP audit activity, develop and present periodic metrics and risk management to company leadership.
  • Global GPvP Training: Provide global GPvP training when requested.
  • Inspection Readiness: Lead the preparation and conduct of mock and regulatory agency inspections and report responses.
  • Continuous Improvement: Identify gaps in systems and processes and implement procedures as part of continuous improvement.

Basic Requirements:

  • Minimum bachelor's degree in nursing, pharmacy, or allied health/science.
  • 15-20 years of pharmaceutical industry experience within the Quality/Compliance Oversight of Drug Safety, Clinical, Regulatory, and/or Medical Affairs disciplines.

Preferred Requirements:

  • Experience in global GPvP regulations, Part 11 computer systems, all types of PV internal and external auditing.
  • Working knowledge of US, International Conference on Harmonization (ICH), and EU GPvP regulations and guidelines.
  • Good interpersonal skills and excellent oral and written communication skills.
  • Knowledge of safety and sample management systems (e.g., Argus, ARISg, Trial Works, and IMPACT) as well as standard tracking databases (e.g., Track Wise).

Travel Requirements:

  • 20-30% travel.

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