Quality Operations Laboratory Manager
About The Position
The Quality Operations Laboratory Manager leads a team of Environmental Monitoring analysts in routine sampling, testing, start-up, and method transfer activities at the Durham site. The role reports to the Associate Director, Laboratory Operations, and supports microbiological testing and environmental monitoring. Method transfer activities may include qualification of equipment, facilities, and utilities. The manager works cross-functionally across company laboratories and organizations to maintain existing facilities or start up new ones, supporting routine environmental monitoring, trending, operational needs, and potential start-up testing of new or modified facilities and utilities. The work applies the company's Production Systems, Lean Laboratories principles, and GMP requirements. The manager supports cGMP and regulatory compliance during facility design, construction, start-up, method transfer and validation, and routine product testing. Responsibilities also include working with internal sites and global partners to build testing capability, collaborating with customers and vendors, supporting project timelines and budgets, and maintaining relationships across site leadership, stakeholders, customers, suppliers, and regulatory agencies. The position represents Quality in the laboratory, supports audits and inspections, and contributes to laboratory and manufacturing quality initiatives. The position is based primarily in Durham, North Carolina. The listed shift options are first (day), second (evening), and third (night); the posting does not specify which shift applies to this role. Travel requirements are 10%. Relocation is not offered, and visa sponsorship is not offered.
Requirements
- Bachelor's or master's degree in Biological Sciences.
- At least 5 years of laboratory experience.
- Experience executing and troubleshooting microbiological testing.
- Experience in Environmental Monitoring, including sampling, testing, and reporting.
- Experience with aseptic handling techniques.
- Technical writing skills.
- Previous GMP laboratory experience.
- Ability to work effectively in an automated or electronic laboratory environment.
- Understanding and application of cGMP/GLP, Compendial, and other applicable regulatory requirements for analytical testing.
Nice To Haves
- Leadership experience.
- Experience in new assay development, validation, and/or technology transfer.
- Experience authoring technical documents supporting regulatory filings, including FDA, EMA, or JNDA filings.
- Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry.
- Experience with regulatory agency audits and/or regulatory filings.
- Experience with Lean Six Sigma and problem-solving tools.
Responsibilities
- Lead a team of Environmental Monitoring analysts in routine sampling, testing, start-up, and method transfer activities.
- Support routine Environmental Monitoring, trending, operational support, and start-up testing for new or modified facilities and utilities.
- Work cross-functionally with internal sites, global partners, laboratories, and other organizations to build and operate testing capabilities.
- Collaborate with internal customers and vendors to execute method transfer or method validation activities.
- Apply project management concepts to laboratory testing start-up, regulatory requirements, project timelines, and budgeting.
- Author and review technical documents, standard operating procedures, change controls, and investigations related to laboratory methods.
- Troubleshoot laboratory process and equipment issues.
- Manage samples and plan and execute testing to meet established delivery timelines.
- Provide active support during regulatory, internal, and safety audits and inspections.
- Assist regulatory groups by providing documentation for licensure supplements and new product license registrations.
- Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements.
- Support Manufacturing Division and Quality initiatives, as well as additional project and routine testing needs.
- Lead project team initiatives to meet timelines and ensure laboratories are ready for routine product testing.
- Escalate potential cGMP or compliance issues in a timely manner.
- Assist in controlling costs related to the role.
- Perform other duties requested by management to support laboratory operations and performance metrics.
Benefits
- Medical, dental, and vision healthcare benefits.
- Other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays.
- Vacation.
- Compassionate and sick days.
- Eligible for an annual bonus and long-term incentive, if applicable.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
