Associate Director, GMP Quality Assurance

Reports to: Director, GMP Quality Assurance

Location: Princeton, NJ (hybrid)

This role is responsible for providing GMP QA expertise, oversight, and auditing support of contract manufacturing organizations of small molecule, oral dosage formulations. Additionally, this role supports PMV’s GxP procedures program, document control, and training activities, utilizing an electronic document management system.

Responsibilities

• Support GMP QA activities spanning across CMC (Chemistry, Manufacturing & Controls) for drug substance, drug product, and clinical trial material, for all outsourced GMP activities.
• Ensure all API, drug product and packaged and labelled investigational material meet GMP regulations, as applicable to phase of development, and are released in a timely manner.
• Collaborate with CMC, Clinical Supplies Management, Regulatory Affairs, and other departments to resolve quality issues and implement process improvements.
• Review and approve GMP-related documents, including master and executed batch records, SOPs, material specifications, and analytical documents (test methods, analytical data, stability data and associated protocols and reports).
• Monitor and report on key quality metrics and trends.
• Stay current with industry best practices and regulatory changes, and ensure the organization is prepared for compliance.
• Participate in risk assessments and provide quality input for new product development and process changes. Support risk-based management activities including change control, deviation and CAPA management.
• Foster a culture of quality and continuous improvement within the organization.
• Maintain GMP electronic document files in an organized and compliant manner.
• Provide GMP QA expertise to the development of the commercial supply chain and ensure inspection readiness.
• Support the development / amendment of Quality Assurance Agreements with GMP vendors and key raw material suppliers.
• Lead and support audits and associated vendor audit plans specifically supporting GMP activities.
• Review CMC sections of global regulatory submissions to ensure consistency with applicable GMP regulated activities.
• Support regulatory inspectional activities including at PMV and GMP contract manufacturing sites.
• Up to 10% Travel / Field work is required to domestic and international locations in a lead / support role with consultants, partners, subject matter experts, inspectors, etc.
• Provide support to QMS system activities including system security, access, upload, and computer validation activities as needed.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• Minimum of 7 years of experience in pharmaceutical GMP QA. Experience with small molecule API and solid oral dosage form manufacturing, preferred.
• Experience in QA oversight of global GMP contract manufacturing organizations. Previous experience with Chinese CMOs a plus
• In-depth knowledge of GMP regulations, quality systems, quality assurance, quality control, and health authority inspections.
• 2 years’ experience in conducting GMP audits of contract manufacturing, packaging, and labelling facilities domestically and internationally, EU and APAC preferred.
• Experience in the use of electronic document management systems (eDMS) such as Veeva (Veeva preferred) Trackwise or, MasterControl.
• Knowledge of risk management approaches in clinical phase and commercial manufacturing.
• Ability to work both independently with minimal direction and within project teams, supporting multiple projects simultaneously.
• Strong verbal / written communication and presentation skills.
• Ability to work well in a deadline-driven environment.
• Excellent computer skills in use of Microsoft Office (Excel, Word, PowerPoint) and Adobe Acrobat.

PMV provides a competitive benefits package that includes a choice of health, dental, and vision insurance, life insurance, flexible spending accounts, 401K plan, PTO, and stock options.