Manager, Quality Control

Location/Division Specific Information

As part of the Thermo Fisher Scientific team youll 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 worlds 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.

• This is a fully onsite position. Unfortunately relocation assistance is NOT provided. Priority will be given to LOCAL candidates currently residing in Southern California.
• Must be legally authorized to work in the United States without sponsorship now or in the future.
• Must be able to pass a comprehensive background check which includes a drug screen.
  

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 materialdisposition andparticipate 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

• Bachelors degree inChemistry Biology Biochemistry Pharmaceutical Sciences or related scientific field required.

• Advanced degree in a technical or business discipline preferred.

Experience

• Minimum of8years of progressive experiencein Quality Control laboratory operations within the life sciences or regulated pharmaceutical/biotech industry.

• Minimum of3 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 within a regulated life sciences manufacturing environment including oversight of laboratories performing molecular biology biochemical chromatographic cell-based and radiological testing.

• Working knowledge of applicable safety regulatory and compliance requirements for specialized laboratory operations including BSL-2 environments radioactive materials and radiation-based assays and controlled substances with appropriate understanding of requirements for personnel authorization safe handling access and inventory controls documentation storage and disposal.

• Working knowledge of applicable cGMP ISO Quality Management System and regulatory requirements including relevant FDA EMA and ICH requirements sufficient to provide effective QC laboratory oversight and leadership.

• Strong knowledge and practical application of method validation and qualification laboratory investigations data integrity requirements and laboratory information management systems (LIMS).

• Strong understanding of equipment qualification calibration maintenance and lifecycle requirements for analytical instruments.

• Demonstrated ability to use laboratory performance data and quality metrics to identify risk establish priorities and influence operational improvement.

• Strong leadership and people-development capabilities with the ability to build high-performing laboratory teams develop talent establish clear accountability and lead through change.

• Demonstrated ability to exercise sound scientific judgment and make timely risk-based decisions in complex situations involving analytical and release testing manufacturing operations product quality and business priorities.

• Strong cross-functional leadership and influencing skills with the ability to effectively challenge align and partner with Operations Manufacturing Sciences Quality Systems & Compliance Regulatory Affairs R&D and other stakeholders.

• Strong knowledge and application of continuous improvement methodologies including Practical Process Improvement (PPI) Lean and/or Six Sigma principles.

• Excellent written and verbal communication skills with the ability to clearly communicate quality risks laboratory priorities recommendations and decisions to audiences ranging from technical teams to senior leadership.

• Demonstrated ability to manage multiple priorities laboratory capacity productivity financials and resources while appropriately escalating significant risks and maintaining quality standards and compliance.

• Strong customer focus and commitment to workplace safety biosafety radiation safety data integrity product quality and regulatory compliance with an understanding of how laboratory performance and analytical results impact manufacturing operations and customer outcomes.