Senior Manager Quality Control

About the role

We are seeking an experienced Quality Control professional to support analytical testing activities for biologic drug development programs. This individual will serve as a key liaison between internal teams and external testing laboratories, ensuring high-quality analytical support for GMP testing, method validation, and product release activities. This is an excellent opportunity for someone with strong biologics experience, particularly in monoclonal antibody programs, who enjoys working cross-functionally in a fast-paced, growing environment.

Responsibilities

• Oversee day-to-day Quality Control testing activities conducted by contract manufacturing organizations (CMOs) and external testing laboratories.
• Act as a primary technical contact for external laboratory partners and participate in operational and scientific discussions.
• Support analytical method validation, qualification, and transfer activities.
• Troubleshoot analytical methods, assay performance issues, testing delays, and laboratory-related challenges.
• Manage sample logistics and tracking, including shipment coordination, testing status updates, and result timelines.
• Monitor laboratory performance and ensure testing schedules and deliverables remain on track.
• Coordinate testing priorities, sample requirements, and laboratory capacity planning.
• Collaborate closely with Quality Assurance, Analytical Development, Manufacturing, and other cross-functional teams.
• Support GMP testing activities and product release timelines.
• Communicate technical findings, project risks, and testing updates to internal stakeholders.
• Build strong relationships with external testing partners and effectively manage timelines, priorities, and expectations.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Biology, Pharmaceutical Sciences, or a related scientific discipline.
• 8+ years of experience with significant Quality Control experience within the biotechnology, pharmaceutical, or biologics industry.
• Hands-on experience supporting biologic drug development programs, including monoclonal antibodies.
• Proven experience with analytical method validation and method transfer activities.
• Strong understanding of GMP regulations and quality requirements related to analytical testing and product release.
• Experience working directly with CMOs, contract testing organizations