GMP Operational Quality Manager
GMP Operational Quality Manager
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Job Description
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.
- Lead and execute with complete ownership of quality agreements with vendors
- Supports Master Batch Records and other vendor documentation required for product release.
Education and Experience:
Minimum of a Bachelors 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:
$115900 - $173800Disclosure 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:
Hybrid-Eligible Or On-Site EligibleFlex 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 Vertexs 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 persons 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
Required Experience:
Director
Employment Type
Full-Time
