Associate Director, GMP Quality Assurance

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the quality aspects of outsourced drug substance and drug product manufacturing, testing, and supply.

• Manage a small, hands-on quality assurance team.

• Provide GMP quality oversight for contract manufacturers, testing laboratories, packagers, and distributors.

• Review and authorize master and executed batch records, deviations, investigations, change controls, and CAPAs.

• Conduct batch disposition for clinical supply in the US and EU, including assistance for Qualified Person certification.

• Establish the commercial quality framework, which encompasses commercial batch release, annual product quality reviews, complaint management, recall preparedness, and stability program supervision.

• Offer QA oversight for process performance qualification, analytical method validation and transfer, along with other critical launch activities.

• Facilitate readiness for pre-approval inspections through gap assessments, mock inspections, and support on inspection days.

• Draft, negotiate, and maintain quality agreements.

• Organize and execute supplier qualification and routine GMP audits, ensuring audit observations are addressed and resolved.

• Develop and enhance risk-based GMP procedures and quality system processes.

• Collaborate with CMC, Supply Chain, Regulatory Affairs, and Clinical Operations to maintain supply timelines and provide quality insights for regulatory submissions.

• Monitor and report on quality metrics and partner performance, escalating compliance risks to leadership.

⛳️ Requirements

• Bachelor's degree in chemistry, pharmacy, biology, engineering, or a related scientific field.

• Over 10 years of GMP experience in the pharmaceutical or biotechnology sector, including more than 5 years in Quality Assurance.

• Proven experience managing CDMOs and contract laboratories, with a focus on batch record review, deviation and CAPA management, and batch disposition.

• Strong understanding of US and EU GMP regulations, including 21 CFR Parts 210/211 and Part 11, as well as EU GMP Annexes 13 and 16, and ICH Q7, Q9, and Q10.

• Direct participation in at least one regulatory GMP inspection.

• Experience in drafting quality agreements and conducting GMP audits.

• Exceptional communication and influencing abilities.

• Capability to work both independently and collaboratively in a lean, matrixed organization with external partners.

• Willingness to travel up to 25%, including visits to partner sites in Europe.

• Preferred experience in supporting a first commercial launch, particularly in process validation, pre-approval inspections, and marketing application CMC content.

• Preferred experience with small-molecule drug substances and oral solid dosage forms.

• Prior experience in developing quality systems within a small or virtual company is preferred.

• Familiarity with an eQMS like Veeva is preferred.

🏝️ Benefits

• Equity

• Bonus

• Remote work arrangement

• Commitment to equal opportunity and fostering a diverse, inclusive, and equitable workplace