Operational Area Quality Senior Manager

Senior Manager, Operational Quality

General Summary :

The Senior Manager, Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. The Senior Manager coordinates or executes activities on multiple complex projects and takes a role in the design and execution of new projects. This role is responsible for primary QA oversight of commercial drug product manufacturing performed at Vertex's external vendors. The role also provides supporting oversight for commercial drug substance operations. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high-level combination product quality alignment.

Key Duties and Responsibilities :

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
• Participates in cross-functional teams as an experienced Quality technical resource
• Drafts and enforces Quality Agreements between CMOs / Suppliers and Vertex, as needed
• Assists Change Control owners with ensuring compliance to change procedure requirements
• Initiates and assesses change controls
• Conducts quality investigations / deviations and reviews corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Ensures appropriate CAPA actions are identified and addressed.
• Performs review and approval of master and executed batch records to support drug substance (DS), drug product (DP), device (Autoinjector) and finished goods (FG) disposition activities
• Lead DP governance, supplier performance monitoring and improvement, quality risk reviews, and partnering with external manufacturers.
• Provides tactics to address compliance gaps or recommends enhancements to cross-functional quality systems
• Conducts GMP document review, including procedures, work instructions, specifications, methods, protocols, and method reports
• Responsible for coordinating, facilitating and follow up on any QLT action items assigned.
• Identify and communicate risks and assist with risk mitigation plans as necessary
• Supports internal audit or external audit programs
• Provides QA support for regional / global submissions supporting new market entry or post-approval changes.
• Provides technical advice for partner and regulatory agency audits

Knowledge and Skills :

Education and Experience :

Bachelor's degree in a scientific or allied health field (or equivalent degree)

Typically requires 6+ years of experience, or the equivalent combination of education and experience

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Pay Range : $132,900 - $199,400

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.

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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.