Director of Quality - BioTalent : Job Details

Get AI-powered advice on this job and more exclusive features.

Direct message the job poster from BioTalent

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 level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at BioTalent by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Paid maternity leave

Paid paternity leave

Get notified about new Director of Quality jobs in Boston, MA

Senior Director / Vice President, Quality

Somerville, MA $177,000.00-$266,000.00 2 days ago

Sr. Director, R&D Quality and Compliance

Senior Manager/Associate Director, Quality

Waltham, MA $137,500.00-$261,000.00 4 days ago

Associate Director, Quality Assurance CMO Management (Hybrid)

Cambridge, MA $200,000.00-$225,000.00 12 hours ago

Senior Director, Operational Quality & Compliance

Sr. Director, R&D Quality and Compliance

Director/Sr. Director, Quality Systems and GxP Compliance

Burlington, MA $170,000.00-$180,000.00 3 weeks ago

Director, Food Safety and Quality Assurance

Deputy Director for Design Quality Assurance

Boston, MA $175,000.00-$200,000.00 2 weeks ago

Associate Director, Quality Management Systems

Waltham, MA $185,000.00-$227,000.00 4 days ago

Boston, MA $176,000.00-$264,000.00 5 days ago

Director of Quality and Program Integrity

Chelmsford, MA $80,000.00-$90,000.00 2 months ago

Director, Quality Assurance & Analytics

Director of Operations for a Love Coaching Company

Associate Director, Clinical Quality Assurance

Greater Boston $160,000.00-$200,000.00 2 weeks ago

Associate Director, Quality - GMP/ Med Device

Sr. Director, R&D Quality and Compliance

Senior Director, GCP/GVP Quality Assurance

Boston, MA $260,000.00-$275,000.00 4 days ago

We're unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.