Associate Director Post Marketing Quality

Associate Director of Post-Marketing Quality Assurance

Role summary:
Lead post-marketing quality oversight to ensure continued compliance of commercial pharmaceutical products throughout their lifecycle. Provide strategic and operational oversight of third-party logistics centers, distribution partners, and pharmacovigilance interfaces. Represent Quality on the commercial launch team to incorporate quality elements into product launch timelines.

Responsibilities:
- Manage product complaints, field alerts, and product recalls; collaborate with medical affairs and product safety teams.
- Lead responses for potential defective product, serious deviation, or recall/Field Corrective Actions, including reporting to the appropriate Regulatory Agency.
- Define quality and performance objectives; analyze metrics and report trends to management.
- Participate in supplier qualification activities (e.g., supplier audits, develop/implement quality agreements).
- Oversee suppliers for packaging, labeling, and distribution of commercial products.
- Ensure timely investigations, root cause analysis, and CAPA implementation.
- Release finished products for distribution in the US.
- Review and approve labeling and artwork for US.
- Review batch-related documentation to ensure GMP compliance for finished product release.
- Oversee deviation investigations for packaging and shipping events.
- Provide QA oversight and approve Change Control records impacting product distribution and implementation.
- Ensure distribution procedures align with US FDA requirements and other applicable country/state board of health requirements.
- Author and/or revise controlled documents (e.g., SOPs, controlled forms, work instructions).

Qualifications & Experience:
- Bachelor’s degree preferred; or at least 5 years of experience in a GMP-related field in biotechnology/biologics/pharmaceutical manufacturing.
- ASQ Auditor certification is a plus.

Required/Preferred Skills:
- Extensive knowledge of quality system requirements (US FDA GMP, GCP, EMA, ICH) with a track record of successful implementation.
- Proficiency with quality tools (lean, six sigma, risk management/risk-based tools).
- Ability to interact with regulatory health authorities.
- Ability to lead and influence cross-functional teams to ensure compliance.
- Ability to present information to staff, customers, regulators, and executive management.
- Excellent interpersonal, verbal, and written communication skills.
- Proficient in MS Word, Excel, PowerPoint; Veeva QMS is a plus.
- Knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211).
- Strong knowledge of GMP, SOPs, and quality systems related to document management.