Manager, Quality Control

Manager, Quality Control

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.

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.

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 View email address on click.appcast.io