GMP Operational Quality Manager

Job Description

General Summary:

The Quality Manager is a technical resource in the principles and application of quality assurance and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.

Key Duties and Responsibilities:

• Provides quality assurance support in the design and development of combination medical device products, facilitating the application of design controls and risk management. Supports Design History File establishment, creation, approval, and maintenance
• Supports Design History File audits at Phase Gates to ensure product development projects comply with applicable design control regulations (21 CFR 820) and company policies and procedures.
• Reviews and approves design documentation including, but not limited to, verification and validation methods, test plans, protocols and reports, test and inspection documents, design engineering drawings, statistical analysis methods, and risk documents (design and process).
• Familiar with Risk Analyses, including d.F.M.E.A., u.F.M.E.A., and p.F.M.E.A. Able to present to Cross-Functional Team for input, revision, and closure. Must be familiar with U.S. FDA and E.U. Risk Analysis methods, as well as those of other regulatory jurisdictions.
• Reviews new and modified product designs for quality characteristics, including manufacturability, testability, reliability, biocompatibility, sterility, and conformance to product requirements.
• Supports Change Control, works with the Cross-Functional Team for Impact Assessment, and ensures the timely completion of activities while updating relevant documents in the Design History File.
• Supports the technical aspects of New Product Commercialization by effectively utilizing product knowledge and first-generation learnings to inform the efficient Design and Development of subsequent product generations.
• Familiar with Root Cause Analyses relating to Process and Product Development. In addition, with cross-functional input, authors and supports study protocols and applicable testing regimens, and documents all Root Cause Analysis Reports.
• Performs Design History File Remediation as required, including, as applicable, review and revision of all Design and Quality System Documentation.
• Investigate product complaints and reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements.
• Supports vendor management and third-party auditing assessments.
• Supports Master Batch Records and other vendor documentation required for product release.

Education and Experience:

• Minimum of a Bachelor's degree in Engineering with 5+ years of experience working in a regulated medical device environment. Experience with device-biologic combination products

• Proven experience with Medical Device Product Development, ownership and authorship of Design History Files, leading Device Risk Management initiatives, and Lifecycle Management.

• Working knowledge of Process Instrumentation and Controls, development and characterization of Test Methods for selection, verification and validation of components, sub-systems and assemblies.

• A thorough understanding of c.G.x.P principles and practices, ISO 13485, ISO 14971, and 21C.F.R.820.

#LI-hybrid

Pay Range:

Disclosure Statement:

Flex Designation:

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: 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 ApplicationAssistance@vrtx.com