Director, Product Quality – USA Remote

Global Life Science Hub is currently seeking a Director of Product Quality for an innovative biopharmaceutical company dedicated to transforming the treatment landscape for brain diseases. This company, a leader in the field, focuses on developing groundbreaking therapies for neuropsychiatric disorders and neurodegenerative diseases.

Our client is a clinical-stage biopharmaceutical company founded to address the global brain disease crisis with a unique approach to drug development. Their therapeutic pipeline comprises multiple clinical and preclinical neuroscience programs targeting various neuropsychiatric disorders and neurodegenerative diseases. Supported by advanced translational, clinical, and computational tools, they aim to redefine neuroscience drug development for improved patient outcomes.

Responsibilities:

• Manage GMP manufacturing, release, stability, and validation activities for Neumora’s small-molecule assets.
• Oversee batch disposition of drug substance, drug product, packaging, and labeling, including review/approval of protocols, methods, reports, and GMP source documents.
• Collaborate with Technical Operations for Drug Substance/Product/Bottling/Labeling to ensure cGMP conformance.
• Review and approve Master Batch Records (MBRs) in compliance with GMP regulations and regulatory submissions.
• Approve executed batch records, analytical data, stability protocols/reports, ensuring GMP compliance for substance and final product release.
• Review and approve validation protocols, raw data, and reports (Method, Process, Cleaning, etc.).
• Conduct data integrity/compliance assessments, including review against source docs for regulatory submissions.
• Support internal Change Control, Deviation, and Quality Investigation systems.
• Compile/archive MBRs, EBRS, and associated batch release documentation.
• Communicate effectively with CDMOs to achieve Quality objectives aligned with project timelines.
• Support Annual Product Review and Product Quality processes.
• Assist in FAR/Withdrawal and Product Recall processes.
• Provide oversight of CMO/CTL inspection readiness (e.g., PAI).
• Perform vendor audits domestically and internally.

Qualifications:

• B.S./M.S. degree in analytical chemistry or related life sciences with at least 15 years of quality assurance experience in pharmaceutical product development.
• Strong knowledge of cGMP compliance for manufacturing and testing drug substance/product.
• Familiarity with ICH requirements related to CMC activities for NDA/MAA registration.
• Experience in CDMO management and cross-functional collaboration.
• Ability to work effectively in a team/matrix environment and independently.
• Strong time management skills, ability to meet deadlines, and handle multiple assignments.
• Excellent written and verbal communication skills.
• Accuracy and attention to detail in procedures and assignments.
• Willingness to travel (10%).
• Preferred: Other Compliance or Regulatory certifications (e.g., RAC, ASQ), experience auditing suppliers/CMOs/CTLs, Veeva experience, familiarity with small molecule pharmaceutical development and testing for oral dosage forms, and work experience in a virtual biopharmaceutical development model.

Global Life Science Hub is a niche Life Science recruitment consultancy. We place professionals across the EU & USA for a variety of CRO, CDMO, and Pharma/Biotech companies ranging from small start-ups to large global organisations.

If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com or reach out to us via:

• Tel: +44 (0) 204 599 8130
• Email: christopher@glshub.com