Quality Control Lab Manager
About the Company
Our client is a well-established contract manufacturing organization that partners with leading consumer healthcare, pharmaceutical, and regulated product companies to develop, manufacture, and package a diverse portfolio of products. With a strong focus on quality, compliance, and operational excellence, the organization supports customers through the full product lifecycle, from development and scale-up through commercial manufacturing. This role offers the opportunity to join a growing quality organization and make a meaningful impact on laboratory operations, compliance initiatives, and continuous improvement efforts.
Position Summary
Our client is seeking an experienced Quality Control Laboratory Manager to oversee laboratory operations, lead a team of quality professionals, and ensure testing activities meet regulatory, quality, and business requirements. This individual will serve as a key leader within the Quality organization, providing technical expertise, driving continuous improvement, and supporting both internal stakeholders and external customer relationships.
Key Responsibilities
- Lead day-to-day laboratory operations, ensuring timely and compliant testing of raw materials, in-process samples, finished products, and stability samples.
- Manage, mentor, and develop laboratory personnel, fostering a culture of quality, accountability, and continuous improvement.
- Review and approve laboratory documentation, including specifications, test methods, protocols, reports, and standard operating procedures.
- Drive investigations related to deviations, OOS/OOT results, nonconformances, complaints, and CAPA activities.
- Partner with cross-functional teams to support manufacturing operations, product transfers, process improvements, and customer initiatives.
- Provide technical leadership for analytical method development, validation, verification, and troubleshooting activities.
- Support internal audits, customer audits, and regulatory inspections while maintaining inspection readiness.
- Oversee laboratory equipment, vendor relationships, calibration programs, and resource planning to ensure efficient operations.
- Ensure compliance with applicable regulatory requirements, cGMP standards, company procedures, and quality system expectations.
Qualifications
- Bachelor's degree in Chemistry, Biology, Microbiology, or a related scientific discipline; advanced degree preferred.
- 7+ years of quality control laboratory experience within a regulated manufacturing environment.
- Prior leadership experience managing laboratory teams and driving performance in a fast-paced setting.
- Strong knowledge of cGMP regulations, quality systems, investigations, CAPA, and laboratory compliance requirements.
- Experience supporting audits and regulatory inspections, including interactions with health authorities and customers.
- Expertise in analytical testing, laboratory operations, method validation, and quality risk management.
- Strong communication, problem-solving, and project management skills with the ability to collaborate across multiple functions.
Why Join?
This is a highly visible leadership opportunity within a growing manufacturing organization where quality is a strategic priority. The successful candidate will have the chance to build and develop a high-performing laboratory team, influence quality initiatives across the site, and play a key role in supporting customer success and operational excellence.
FAQs
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