Job Details

Senior Manager, GMP Quality 

The Opportunity:

Seeking a Senior Manager, GMP Quality who will play a key role within Quality Assurance and is responsible for providing leadership and operational support for programs through different phases of development.

Responsibilities:

• Responsible for providing QA support for batch disposition, quality record ownership, and management of QA activities.

• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.

• Collaborate with internal and external stakeholders and execute quality systems as the QA SME on deviation investigations, CAPA plans, change controls, shelf-life extensions, revisions to documentation, and other Quality processes.

• Lead efforts for QA oversight of the manufacture, validation, and disposition of pre-clinical, clinical, and commercial product materials, including drug substance (DS), drug product (DP), and final product (FP) at CMOs in partnership with PDM (CMC), Supply Chain, Analytical Development, and other functions.

• Establish and maintain internal quality metrics for the GMP Quality group that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.

• Provide Quality oversight as well as review and approval of CMO documentation (e.g., specification documents, Method Validations, Stability records, Master Batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and perform product dispositions.

• QA lead in periodically reviewing and revising GMP-related SOPs and procedures.

• Support quality review of regulatory documents (IND/IMPD, NDA) to ensure compliance with late-stage and commercial drug product validation requirements.

• Participate in inspection readiness efforts, particularly for late-stage development and commercial launch preparations.

• Build positive professional relationships and trust to support learning, respect, open communication, collaboration, and teamwork.

Required Skills, Experience and Education:

• A Bachelor’s degree in a scientific or technical discipline is required.

• A minimum of 8 years of experience in GMP Quality in the pharmaceutical industry, with experience in late-stage drug product development and validation, is required.

• Experience managing quality aspects of development, validation, manufacturing, and testing activities at CMOs.

• Experience in process validation (PPQ), late-stage regulatory submissions, and commercial readiness.

• Experience in Inspection Readiness (domestic and ex-US).

• Excellent analytical skills and a strong technical background in small molecule process development, validation, and testing are strongly desired.

• Knowledge of applicable US and Global compliance regulations and industry practices.

• Ability to critically evaluate and troubleshoot complex problems with diligence.

• Strong teamwork, collaboration, and management skills.

• Ability to manage multiple priorities and aggressive timelines.

• Highly responsible, self-motivated professional with enthusiasm and passion for the work.

• Highly proficient with various Microsoft and other computerized systems (e.g., Word, Outlook, Excel, PowerPoint, Visio, etc.).

Preferred Skills:

• Experience in auditing vendors and suppliers is preferred.