Associate Director, Product Quality
Kymera Therapeutics
6 months ago
Remote friendly (Greater Boston)
United States
Operations
How you’ll make an impact:
The Associate Director will serve as a Quality subject matter expert for Good Manufacturing Practices (GMP) activities, responsible for material disposition and Quality oversight for technical transfers, stability assessments, manufacturing, analytical, and distribution activities performed at external suppliers, ensuring compliance with regulations and company policies/procedures.
Responsibilities:
- Provide quality oversight of contract organizations for the manufacturing and distribution of Drug Substances, Drug Products, and Finished Goods.
- Collaborate with manufacturing and distribution teams to review manufacturing batch records, protocols, reports, and specifications; perform disposition of critical intermediates, drug substances/drug products, and finished goods.
- Partner with CMC analytical colleagues to review test methods, SOPs, analytical data summaries, validation and stability protocols, and technical reports; oversee specification control and shelf life management.
- Ensure product quality issues (deviations, OOSs, OOTs, and product complaints) are investigated and resolved.
- Collaborate cross-functionally with internal and external partners.
- Support preparation and review of regulatory filing submissions (IND/IMPD/NDA).
- Develop and implement phase-appropriate SOPs and policies; ensure compliance with FDA, EMA, and ICH guidelines.
- Manage qualification and performance monitoring of external GMP suppliers; maintain Quality Agreements.
- Develop and track quality metrics and present assessments to the Material Review Board and Quality Management Review Board.
- Support late-stage manufacturing and commercialization readiness activities.
Skills and experience you’ll bring:
- 8+ years in pharmaceutical manufacturing or laboratory settings, including at least 4 years in a GMP quality assurance role; small-molecule manufacturing experience preferred.
- Experience providing Quality oversight of outsourced late-phase GMP manufacturing, including process validation and commercial readiness.
- Excellent communication and interpersonal skills.
- Experience working in a CMC team as a Quality representative.
- Ability to work independently and manage multiple projects within timelines and objectives.
- Strong problem-solving skills; ability to make risk-based decisions on quality matters.
The Associate Director will serve as a Quality subject matter expert for Good Manufacturing Practices (GMP) activities, responsible for material disposition and Quality oversight for technical transfers, stability assessments, manufacturing, analytical, and distribution activities performed at external suppliers, ensuring compliance with regulations and company policies/procedures.
Responsibilities:
- Provide quality oversight of contract organizations for the manufacturing and distribution of Drug Substances, Drug Products, and Finished Goods.
- Collaborate with manufacturing and distribution teams to review manufacturing batch records, protocols, reports, and specifications; perform disposition of critical intermediates, drug substances/drug products, and finished goods.
- Partner with CMC analytical colleagues to review test methods, SOPs, analytical data summaries, validation and stability protocols, and technical reports; oversee specification control and shelf life management.
- Ensure product quality issues (deviations, OOSs, OOTs, and product complaints) are investigated and resolved.
- Collaborate cross-functionally with internal and external partners.
- Support preparation and review of regulatory filing submissions (IND/IMPD/NDA).
- Develop and implement phase-appropriate SOPs and policies; ensure compliance with FDA, EMA, and ICH guidelines.
- Manage qualification and performance monitoring of external GMP suppliers; maintain Quality Agreements.
- Develop and track quality metrics and present assessments to the Material Review Board and Quality Management Review Board.
- Support late-stage manufacturing and commercialization readiness activities.
Skills and experience you’ll bring:
- 8+ years in pharmaceutical manufacturing or laboratory settings, including at least 4 years in a GMP quality assurance role; small-molecule manufacturing experience preferred.
- Experience providing Quality oversight of outsourced late-phase GMP manufacturing, including process validation and commercial readiness.
- Excellent communication and interpersonal skills.
- Experience working in a CMC team as a Quality representative.
- Ability to work independently and manage multiple projects within timelines and objectives.
- Strong problem-solving skills; ability to make risk-based decisions on quality matters.