Manager, Quality Control

Vertex Pharmaceuticals LLC; Boston (MA); Hybrid; USD 118,000 - 177,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Commuting subsidy

Paid time off

Job summary

Vertex Pharmaceuticals LLC in Boston is seeking a Manager, Quality Control to oversee analytical functions across the Vertex Manufacturing Center and Leiden Center, ensuring testing and reporting on in-process, release, and stability samples meet cGMP standards. The role includes night shift leadership and formal people management responsibilities.

The position requires a Bachelor’s degree in science with 8+ years in pharma/biopharma and hands-on expertise in flow cytometry, sterility, and

Qualifications

• Bachelor’s degree in science with 8+ years in pharmaceutical/biopharmaceutical industry.
• Strong knowledge of cGMP regulations and quality systems.
• Experience leading QC teams and cross-functional projects.

Responsibilities

• Lead laboratory programs in QC, including data review, reporting, and readiness.
• Coordinate and oversee training, sample management, and metrics publication.
• Provide guidance during investigations (OOS/OOT) and implement corrective actions.
• Represent QC in cross-functional teams and with external vendors as needed.

Skills

QC management

cGMP knowledge

regulatory awareness

Education

Bachelor's degree in science

Tools

Flow cytometry

Sterility testing

Endotoxin testing

Job description

## Manager, Quality ControlApply: Boston, MA: Full time: Posted Today: REQ-30149**Job Description****General Summary:**The Manager, Quality Control is a key position that provides oversight of a variety of analytical functions that occur across the Vertex Manufacturing Center (VMC) and Leiden Center (LC1) supporting testing, and reporting of in-process, release, and stability samples. This role also ensures activities occur in an efficient and cGMP compliant manner. The role is a third shift position, Wednesday through Saturday, and will have formal people management responsibilities. ***Work shift:** Wednesday to Saturday, night shift between the hours of 9:00pm to 9:00am***Key Duties and Responsibilities:*** Independently manages a variety of laboratory program(s)/processes within the department (assay readiness, training, sample management, data review and reporting and serves as Quality Control representation at triage and Quality Control contact for Quality Events.* Coordinates and facilities laboratory activities to meet commitments on time* Ensures lab personnel have appropriate training.* Assists in troubleshooting of analytical methods and/or equipment as required* Authors, review, and/or approves data, SOPs,* Assists in monitoring, tracking and publishing lab metrics* Ensures all laboratory records adhere to cGMP/GDP expectations* Leads sub-teams working towards the goal of continuous improvement* May be required to lead OOS/OOT investigations/deviations and to identify corrective actions to prevent reoccurrence* Provides guidance to reports when issues arise. Coach and develop reports.* Serves as the Quality Control representative in cross-functional, cross-departmental working teams and/or working with outside vendors to meet all laboratory needs.**Knowledge and Skills:*** Prior QC management experience* Knowledge of US and EU cGMP regulations/guidance and some 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 communication skills, both verbal and written* Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail**Education and Experience:*** Bachelor’s degree in science or related discipline is required with 8 years of experience in pharmaceutical/biopharmaceutical industry, or the equivalent combination of education and experience. At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.**Pay Range:**$117,800 - $176,800**Disclosure Statement:**The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.**Flex Designation:**On-Site Designated**Flex Eligibility Status:**In this **On-Site** designated role, you will work **five days per week on-site** with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.