Senior QA Leader — GMP Compliance & API Excellence

Veranova L P; Harvard (MA); On-site; USD 155,000 - 175,000; Full time

Job summary

Veranova L P is seeking a Senior Manager, Quality Assurance (QA) to lead multiple QA teams and oversee GMP compliance across manufacturing processes at the Devens, MA facility. The role emphasizes ownership, strategic direction, and collaboration with internal and external stakeholders.

Requirements include 10+ years in QA within FDA-regulated environments, 7+ years of supervisory experience, and strong GMP/ICH Q7 and 21 CFR Part 11 knowledge. On-site 1st shift with annual bonus eligibility.

Qualifications

• Minimum 10 years of experience in Quality Assurance in an FDA regulated industry.
• Experience in an API GMP environment preferred.
• Minimum 7 years of supervisory experience.
• Must have GMP, ICH Q7, and 21 CFR Part 11 knowledge.
• Experience with hosting/regulatory facing inspections is required.
• Knowledge of Inventory Management, LIMS, and Quality Management software is desired.

Responsibilities

• Lead QA teams for batch review, batch disposition and on-the-floor QA support to ensure GMP compliance.
• Interface with Clients for project planning and problem resolution with a strong customer service approach.
• Lead or support implementation of critical compliance systems and provide recommendations to operations management.
• Review and approve equipment qualification protocols and results.
• Participate in internal auditing programs to ensure regulatory compliance and company standards.
• Collaborate with Production, Maintenance, and QC for quality decisions.

Skills

Quality Assurance

GMP knowledge

Regulatory compliance

Education

BS or MS in Chemistry, Engineering or related field

Tools

LIMS

Quality Management software

Inventory Management

Job description

Veranova L P is seeking a Senior Manager, Quality Assurance (QA) to lead multiple QA teams and oversee GMP compliance across manufacturing processes at the Devens, MA facility. The role emphasizes ownership, strategic direction, and collaboration with internal and external stakeholders.

Requirements include 10+ years in QA within FDA-regulated environments, 7+ years of supervisory experience, and strong GMP/ICH Q7 and 21 CFR Part 11 knowledge. On-site 1st shift with annual bonus eligibility.