Senior Manager/ Associate Director GMP Quality

Location: Boston, MA preferred but can be remote

Position: Sr. Manager/Associate Director GMP Quality

Reporting to: Director, GMP Quality

The position will be responsible for day-to-day operational support ensuring compliance with current Good Manufacturing Practices (cGMP) for all clinical and commercialization activities. This role will perform GMP operations, from clinical trial material manufacturing, QC testing, distribution and validation. This role will assist in the transition into commercial-scale production. Partner and collaborate with internal and external teams, ensuring alignment on quality standards and the timely execution of all deliverables.

The ideal candidate will possess a strong combination of strategic thinking and hands-on expertise in GMP Quality operations within the biotech industry.

Key Responsibilities

· GMP Quality Oversight: Point of contact for GMP Quality Operations function for clinical manufacturing, distribution, validation and commercialization activities. Support tech transfer as applicable. Ensure all activities comply with relevant regulatory guidelines (FDA, EMA, ICH, etc.) and Quality Agreements.

· Regulatory Compliance: Support regulatory inspections and audits (FDA, EMA, etc.) as assigned.

· Supplier & CMO Management: Provide quality oversight of external manufacturers, contract manufacturing organizations (CMOs), and suppliers to ensure compliance with GMP standards.

· Quality Systems and Compliance: Provide oversight on investigations related to deviations and product quality issues, ensuring timely resolution, root cause analysis and CAPA implementation. Point of contact for 3rd party supplier & CMO quality events. Responsible for inputting quality documents into the eQMS.

· Inspection Readiness: Support functional groups to perform identified inspection readiness activities and provide oversight of vendor inspection readiness activities.

· Documentation Management: Author, review and approval of GMP documentation, including batch records, release specifications, QC data, protocols, validation reports, etc.

· Risk Management: Identify and mitigate quality risks within clinical development and pre-commercialization activities.

· Cross-functional Collaboration: Partner with CMC, Supply Chain, Commercial and Regulatory Affairs teams to ensure quality compliance throughout the product lifecycle from clinical trials to commercial manufacturing.

Qualifications

· Education:

o Bachelor's degree in Life Sciences, Engineering, or a related field.

· Experience:

o Minimum 8 years of experience in quality operations, quality assurance, or GMP manufacturing within the biotechnology or pharmaceutical industry.

o Experience with Phase 3 clinical trials and the transition to commercialization is highly preferred.

· Skills & Competencies:

o Expertise in GMP, regulatory requirements, and industry best practices (FDA, EMA, ICH).

o Ability to collaborate with cross-functional teams and complex initiatives.

o Excellent knowledge of quality systems, documentation, and compliance management.

o Exceptional problem-solving, troubleshooting, and analytical skills.

o Strong communication and presentation skills, both written and verbal.

o Ability to work effectively in a remote, fast-paced, and evolving environment

The salary range for the Senior Manager GMP Quality is expected to be between $160,000 and $175,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

The salary range for the Associate Director GMP Quality is expected to be between $175,000 and $200,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.