Manager, Quality Control

Vertex Pharmaceuticals Inc (US); United States; On-site; USD 118,000 - 177,000; Full time

Benefits offered by this job

Annual bonus

Annual equity awards

Medical benefits

Dental benefits

Vision benefits

Generous paid time off

Educational assistance programs

Commuting subsidy

Matching charitable donations

401(k)

Job summary

Vertex Pharmaceuticals Inc (US) is seeking a Manager, Quality Control to oversee analytical functions across the Vertex Manufacturing Center and Leiden Center, ensuring cGMP compliance and efficient operations. The role includes formal people management and a Wednesday–Saturday 10-hour night shift from 9:00pm to 9:00am.

Responsibilities include guiding lab programs, coordinating activities to meet commitments, ensuring proper training, and approving data and SOPs.

Qualifications

• Bachelor’s degree in science or related discipline with 8+ years in pharma/biopharma.
• Experience in QA/QC regulatory environments and inspections helpful.
• Strong knowledge of analytical methods and GMP expectations.

Responsibilities

• Oversee lab programs within QC department and coordinate activities to meet deadlines.
• Lead troubleshooting of analytical methods/equipment as needed.
• Author/review/approve data and SOPs; monitor lab metrics and records.
• Provide guidance to reports; coach and develop staff.
• Act as QC representative in cross-functional teams and with external vendors.

Skills

QC management

cGMP knowledge

Analytical methods (flow cytometry)

Data review & reporting

Communication skills

Training / coaching

Education

Bachelor’s degree in science or related discipline

Job description

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, 10 hour 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 facilitates 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:

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.

Benefits and Compensation:

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.

• The 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.
• Medical benefits
• Dental benefits
• Vision benefits
• 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.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States.

Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at [e-mail]

Help Us Achieve Our Mission

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions.

The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas.

Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London.

Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For.

For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them.

Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work.

The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible.

We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.