GMP Operational Quality Senior Specialist (Stability)

Job Description

General Summary:

The GMP Operational Quality Senior Specialist is recognized as a subject matter expert in 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 and coordinates GMP activities 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.

Has a good understanding of stability requirements per ICH and experience in stability protocol management.

• Collaborate 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.

• Manages 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 in supporting Quality Event Investigations, RCA and CAPA implementation.
• Experience in assessing and managing Change Controls

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 - $141,200

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:

Hybrid-Eligible Or On-Site Eligible

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.

#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 ApplicationAssistance@vrtx.com