Job Description
General Summary:The GMP Operational Quality Senior Specialist supports the principles and application of quality assurance and regulatory compliance. The incumbent supports or executes a wide range of straightforward activities, and supports new/existing project initiatives. The role works with a high degree of independence to provide QA Analytical support for commercial product stability programs and executes routine tasks and activities in support of QA Analytical function.Key Duties and Responsibilities:•Provides QA review of the GMP data in support of commercial product stability as required.•Collaborates with internal and external business partners to resolve quality issues to ensure compliant solutions in support of QA Analytical function.
•Represents QA Analytical on cross-functional teams as an experienced Quality technical resource as needed.
•Supports quality oversight of Root Cause Analysis (RCA) and product impact assessment for deviation and OOS/OOT investigations. Ensure that appropriate CAPA actions are identified. May approve investigations/CAPAs.
•Supports stability impacting change control activities such as assessment, implementation, and closure.
•Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and reports.
•Supports external stability program activities for commercial products such as internal/external protocol review/approval, data review/approval and study initiation.
•Enforces Quality Agreements between CMOs/Suppliers and Vertex as applicable to stability study pulls, test initiation, data reporting and OOS/OOT management.
•Identifies and facilitates continuous improvement efforts.
•Identifies and communicates risks and assists with risk mitigation plans, where applicable.Knowledge and Skills:•Knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting including knowledge of global GMP requirements in regard to GMP manufacturing and testing.
•Knowledge of basic analytical techniques in a Quality/commercial setting (e.g., HPLC, dissolution, GC, KF, etc.)
•Experience working with Contract Manufacturing Organizations (CMOs)/Contract Testing Organization (CTOs).
•Experience supporting multiple projects/teams, ability to work in a fast-paced environment and meet quality, accuracy and timelines.
•Demonstrated ability to evaluate quality matters and make decisions leveraging technical experience and judgement.
•Good communication skills (written and verbal) and the ability to communicate cross-functionally to a variety of audiences.
•Demonstrated ability to work independently to provide QA advice for large, multifaceted projects
•Experience in supporting Quality Event Investigations, RCA and CAPA implementation.
•Experience in assessing Change Controls
•Experience with electronic document management systems (e.g., LIMS, Veeva).Education and Experience:
- Bachelor's degree in a scientific discipline (or equivalent degree) and 3-4 years of experience, or the equivalent combination of education and experience.
- Advance knowledge of GMP regulations and applicability.
- Operational QA experience in analytical or manufacturing setting, interpretation, and application of GMPs and applicable guidelines/guidance’s ex. ICH, USP, etc.
- Experience in Root Cause Analysis tools/methodology and technical writing.
- Facilitation/problem solving/organizational planning skills in a regulated environment.
Pay Range:
$94,200 - $141,200Disclosure 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 Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
#LI-Hybrid
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 [email protected]
Skills Required
- Bachelor's degree in a scientific discipline or equivalent experience (3-4 years)
- Advanced knowledge of GMP regulations and applicability (cGMP, ICH, USP)
- Operational QA experience in analytical or manufacturing setting
- Experience with Root Cause Analysis tools/methodology and technical writing
- Experience supporting Quality Event Investigations, RCA and CAPA implementation
- Experience assessing and managing Change Controls
- Knowledge of basic analytical techniques (HPLC, dissolution, GC, KF)
- Experience working with Contract Manufacturing Organizations (CMOs) and Contract Testing Organizations (CTOs)
- Experience with electronic document management systems (e.g., LIMS, Veeva)
- Strong written and verbal communication and ability to work cross-functionally
Vertex Pharmaceuticals Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Vertex Pharmaceuticals and has not been reviewed or approved by Vertex Pharmaceuticals.
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Parental & Family Support — Policies provide 12 weeks of 100% paid bonding leave for all U.S. parents with additional fully paid time for birth parents. Family-forming supports include adoption and surrogacy assistance, fertility options like IVF and egg cryopreservation, breast‑milk shipping, subsidized childcare, backup care, and a DCFSA match.
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Leave & Time Off Breadth — Time off includes roughly four weeks of vacation, 13 holidays, sick time, and two companywide shutdowns (summer and year‑end). Some roles also include flexible or unlimited time off and paid volunteer time.
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Retirement Support — Programs include a 401(k) plan with employer contributions and an employee stock purchase plan. Filings describe employer contributions occurring in company stock, supporting long‑term ownership.
Vertex Pharmaceuticals Insights
What We Do
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious and life-threatening diseases. We discovered and developed the first medicines to treat the underlying cause of cystic fibrosis (CF), a rare, life-threatening genetic disease. In addition to clinical development programs in CF, Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases. Founded in 1989 in Cambridge, Massachusetts, our corporate headquarters is now located in Boston’s Innovation District, and our international headquarters is in London, United Kingdom. We currently employ approximately 3,500 people in the United States, Europe, Canada, Australia and Latin America with nearly two-thirds of our staff dedicated to research and development. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. Our research and medicines have also received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the French Prix Galien and the British Pharmacological Society awards.
