Director of Quality - BioTalent : Job Details

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RA/QA Medtech & Life Sciences Recruitment for New England

Summary:

Seeking an experienced quality leader to oversee all quality operations for a GMP pharmaceutical manufacturing site. This role will direct quality assurance, quality control, and compliance functions to ensure product safety, efficacy, and regulatory compliance, while driving continuous improvement across the organization.

Key Responsibilities:

• Lead site-wide Quality Management System (QMS) in compliance with cGMP, FDA, EMA, and ICH guidelines.
• Oversee QA and QC operations, including batch record review, product release, stability programs, and laboratory compliance.
• Manage audits and inspections (FDA, EMA, MHRA, customer) and ensure timely resolution of findings.
• Direct deviation, CAPA, and change control programs; ensure robust documentation and timely closure.
• Partner with manufacturing, supply chain, and R&D to embed quality into processes and projects.
• Oversee supplier quality, raw material qualification, and contract manufacturer oversight.
• Monitor quality metrics and lead continuous improvement initiatives to optimize compliance and efficiency.
• Develop and mentor high-performing quality teams.

Qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or related field (advanced degree preferred).
• 10+ years in pharmaceutical quality roles, including 5+ years in site leadership.
• Expertise in cGMP and regulatory compliance for drug manufacturing.
• Proven success in leading regulatory inspections and driving systemic quality improvements.
• Strong leadership, communication, and decision-making skills.

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesPharmaceutical Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

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