Manager, Quality Control
General Summary
The Manager, Quality Control provides oversight of a variety of analytical functions across the Vertex Manufacturing Center (VMC) and Leiden Center (LC1), supporting testing and reporting of in‑process, release, and stability samples. The role ensures activities are efficient and cGMP compliant and includes formal people‑management responsibilities.
Key Duties and Responsibilities
- Independently manages laboratory programs/processes (assay readiness, training, sample management, data review and reporting) and serves as Quality Control representation at triage and for Quality Events.
- Coordinates and facilities laboratory activities to meet commitments on time.
- Ensures lab personnel have appropriate training.
- Assists in troubleshooting analytical methods and/or equipment as required.
- Authors, reviews, and/or approves data and SOPs.
- Assists in monitoring, tracking, and publishing lab metrics.
- Ensures all laboratory records adhere to cGMP/GDP expectations.
- Leads sub‑teams working toward continuous improvement.
- May lead OOS/OOT investigations/deviations and identify corrective actions to prevent recurrence.
- Provides guidance to reports when issues arise; coaches and develops reports.
- Serves as the Quality Control representative in cross‑functional, cross‑departmental teams and works with outside vendors to meet laboratory needs.
Knowledge and Skills
- Prior QC management experience.
- Knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections.
- Strong knowledge of analytical methodologies such as flow cytometry, cell counts and viability (NC‑200), sterility (BACT), endotoxin, cell culture, and applying/interpretation of GMP requirements.
- Effective verbal and written communication skills.
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines, maintain flexibility, and attend to detail.
Education and Experience
- Bachelor’s degree in science or a related discipline (required).
- Eight years of experience in the pharmaceutical/biopharmaceutical industry, or an equivalent combination of education and experience.
Pay Range
$117,800 – $176,800. This range reflects a reasonable estimate for the base salary at the time of posting. The role is eligible for an annual bonus, annual equity awards, and may be eligible for overtime pay in accordance with federal and state requirements. Actual base salary will be based on factors such as skills, competencies, experience, and other job‑related considerations permitted by law.
Benefits
Vertex offers market‑leading total rewards, including medical, dental, and vision benefits; generous paid time off with a week‑long company shutdown in summer and winter; educational assistance programs (including student loan repayment); a commuting subsidy; matching charitable donations; 401(k); and additional resources to support employees’ financial, family, and wellbeing journeys.
Schedule
Third‑shift position: Wednesday through Saturday, night shift from 9:00 pm to 9:00 am.
Flex Designation
On‑site role with ad‑hoc flexibility; employees work five days per week on‑site. Flex status is subject to Vertex’s Flex @ Vertex Program and may change at any time.