Senior Manager, Quality Assurance - Lab Operations

Role Summary

The Senior Manager, Quality Assurance - Lab Operations oversees QA for GMP laboratory operations, including testing, method validation, and stability programs in a biotech manufacturing environment. Ensures compliance with regulations and internal procedures, maintains data integrity, supports regulatory inspections, and drives continuous improvement across quality control laboratories.

Responsibilities

• Provide strategic and operational QA oversight for GMP laboratory operations, including QC testing, method validation, and stability studies.
• Lead QA review and approval of laboratory documentation such as test records, method validation protocols/reports, and stability data.
• Ensure compliance with cGMP, GLP, and data integrity standards across all lab operations.
• Collaborate with QC, Analytical Development, and Regulatory Affairs to support product release and regulatory submissions.
• Manage and mentor a team of QA professionals supporting lab operations.
• Lead or support investigations related to laboratory deviations, OOS/OOT results, and laboratory incidents.
• Participate in internal audits and regulatory inspections as a QA representative and subject matter expert.
• Drive continuous improvement initiatives to enhance lab compliance, efficiency, and quality culture.

Qualifications

• Experience with electronic laboratory systems (e.g., LIMS, Empower, LabWare).
• Strong leadership, communication, and interpersonal skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Experience supporting regulatory inspections (FDA, EMA, etc.).
• Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field.
• 8+ years of experience in Quality Assurance or Quality Control in a GMP-regulated biotech or pharmaceutical environment.
• 3+ years of leadership or management experience.
• Strong understanding of analytical testing, method validation, and stability programs for biologics.
• In-depth knowledge of cGMP, GLP, ICH guidelines, and data integrity principles.

Skills

• QA leadership and team management
• Laboratory data integrity and regulatory compliance
• Documentation review and approval
• Investigations into deviations and OOS/OOT
• Internal audits and regulatory inspections

Education

• Bachelor's or Master's degree in Life Sciences, Chemistry, or a related field

Additional Requirements

• None