Manager, Quality Control

About this role

Work Schedule First Shift (Days) Environmental Conditions Office Job Description

Manager, QC Location/Division Specific Information As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day by enabling our customers to make the world healthier, cleaner, and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges. The Manager, QC supports the Biosciences Division and is based at our Carlsbad, CA site. This role reports directly to the Director, Quality. DESCRIPTION How will you make an impact? The Manager, QC provides leadership and operational oversight for Quality Control laboratory operations supporting multiple product lines manufactured at the Carlsbad site. This role leads and develops the QC laboratory team, ensuring effective analytical and release testing, regulatory compliance, and reliable laboratory execution while maintaining a culture of quality, data integrity, and continuous improvement. As a QC leader for the site, the Manager partners closely with Operations, Manufacturing Sciences, Quality Systems & Compliance, Regulatory Affairs, R&D, and other key stakeholders to ensure product quality, resolve laboratory and testing issues, and support business objectives. Through sound scientific judgment, data-driven decision making, and cross-functional collaboration, this role advances product quality, laboratory performance, customer outcomes, and operational excellence. What will you do? • Lead, develop, and manage the QC laboratory team, including supervisors and team leads, ensuring effective laboratory operations, building team capability, and driving consistent execution of quality control and testing priorities across multiple product lines.

• Oversee analytical testing operations, including in-process and finished product release testing, troubleshooting investigations, and support for method validation, qualification, and transfer activities, ensuring timely execution and compliance with established methods, specifications, and quality standards.

• Strategically manage laboratory capacity, testing priorities, financials, productivity, and resource allocation to meet manufacturing and business needs while maintaining quality standards and compliance.

• Leverage laboratory performance data and quality trends, including out-of-specification (OOS) results, laboratory deviations, and testing metrics, to identify risks and opportunities, drive deeper investigation when warranted, and partner with cross-functional teams to improve product quality, laboratory performance, and customer outcomes.

• Drive effective QC execution of deviation investigations, change controls, and laboratory-related nonconformance records, ensuring timely progression, thorough root cause analysis, effective resolution, and high-quality documentation in alignment with Quality Systems & Compliance requirements.

• Ensure QC laboratory operations and practices align with applicable cGMP, ISO, Quality Management System, and regulatory requirements, maintaining inspection and audit readiness and partnering with Quality Systems & Compliance and Regulatory Affairs to identify and address laboratory quality or compliance gaps.

• Provide QC leadership for significant laboratory decisions and analytical activities supporting material disposition, and participate as a subject matter expert in site governance forums, including CAPA Review Board, Change Control Review Board, and other cross-functional quality forums, as appropriate.

• Partner with Operations, Manufacturing Sciences, Quality Systems & Compliance, Regulatory Affairs, R&D, and other key stakeholders to resolve significant product and process quality issues related to analytical testing and drive effective, sustainable solutions.

• Champion Practical Process Improvement (PPI) and continuous improvement within the laboratory, using QC insight and cross-functional influence to strengthen analytical testing, laboratory efficiency, product quality, and a culture of quality and accountability.

• Maintain strong alignment with divisional, group, and corporate Quality and Regulatory Affairs organizations to ensure QC laboratory priorities and execution support broader Quality and business objectives.

REQUIREMENTS How will you get here? Education • Bachelor's degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or related scientific field required.

• Advanced degree in a technical or business discipline preferred.

Experience • Minimum of 5 years of progressive experience in Quality Control laboratory operations within the life sciences or regulated pharmaceutical/biotech industry.

• Minimum of 3 years of people leadership experience, with demonstrated success leading, developing, and building capability within QC laboratory teams in a regulated manufacturing environment.

• Experience managing QC laboratory operations across multiple product lines or manufacturing areas with differing analytical and business requirements.

• Demonstrated experience partnering with Operations, Manufacturing Sciences, and cross-functional leadership to resolve product and process quality issues related to analytical testing.

• Experience managing laboratory investigations, deviations, OOS results, and CAPA activities with effective root cause analysis and sustainable corrective actions.

• Experience applying analytical data, quality metrics, and risk management principles to identify priorities and drive laboratory improvement.

• Experience supporting regulatory inspections, customer audits, and other audits within a QC laboratory environment.

Knowledge, Skills & Abilities • Strong knowledge of analytical testing methods, laboratory operations, and QC practices w

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