Vertex Pharmaceuticals

Senior Manager, Operational Area Quality (Combination Products)

Boston, MA · Senior

Sponsorship not specified$134k-$201kDetected 8 days ago

StatisticsComplianceProduct ManagementSupply ChainRecruitingGMPMedical DevicesLeadershipCommunicationCollaborationProblem Solving

About the role

Job Description General Summary The Operational Area Quality Senior Manager provides quality leadership for assembly manufacturing operations supporting medical device and combination products.
Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
Flex Designation: Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1.

Review and approve Manufacturing Batch Records (MBRs), Electronic Batch Records (EBRs), Device History Records (DHRs), and associated manufacturing documentation.
Support complaint investigations and product quality assessments as required.
Provide input into risk management activities, including DFMEA, PFMEA, hazard analyses, and Risk Management Files, to ensure manufacturing risks are appropriately evaluated throughout the product lifecycle.
Promote continuous improvement initiatives to enhance manufacturing quality, compliance, operational efficiency, and product reliability.
Demonstrated experience reviewing and approving MBRs, EBRs, DHRs, product disposition, manufacturing investigations, CAPAs, deviations, change controls, and nonconforming material records.
Demonstrated knowledge of GMP, 21 CFR Part 820, 21 CFR Part 4, ISO 13485, ISO 14971, and applicable combination product regulations.
Experience working with Contract Manufacturing Organizations (CMOs) and external suppliers.
Strong technical problem-solving, investigation, and root cause analysis skills.

$133,800 - $200,600
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.

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 ApplicationAssistance@vrtx.com

This listing is sourced directly from Vertex Pharmaceuticals's careers page and normalized into a canonical job model.