Operational Area Quality Associate Director

Associate Director, GMP Operational Quality

The Associate Director, GMP Operational Quality is an advanced technical resource in the principles and application of quality assurance and compliance. This role is responsible for primary QA oversight of commercial drug substance manufacturing performed at Vertex's external vendors as well as secondary quality support of commercial drug product manufacturing vendors. This position ensures robust sterile manufacturing controls, commercial supply continuity, support for global jurisdictional expansion, and high-level combination product quality alignment. The incumbent will mentor team members to provide individual development in addition to efficient and valuable service to project teams.

Key Duties and Responsibilities :

• Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
• Oversee CMO / Vendor performance, establishment of Quality Agreements and adherence of Quality Agreement terms
• Enable team to achieve team goals / objectives and enable their individual career development
• Develop and maintain compliant quality processes to support GMP activities
• Oversee the QA support of Change Controls, GMP investigations and associated CAPAs.
• 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
• Track performance metrics and report to Sr Management; develops tactics to improve performance outcomes
• Participate in inspection readiness activities and lead Quality development discussions as necessary during regulatory site inspections.
• Support review of regulatory submissions, as applicable
• Lead continuous improvements of department processes, realizing efficiency gains, and ensuring team continues to meet expanding business needs with lean resources.
• Lead 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; assists in preparation of audit responses
• Provide comprehensive knowledge support for partner and regulatory agency audits
• Assist management team in budgeting and scheduling
• Responsible for the following activities related to people management responsibilities :
• Talent Acquisition / Recruiting / Interviewing / Selection / Onboarding
• Accountable to provide oversight of day to day team operations

Knowledge and Skills :

Education and Experience :

Pay Range : $154,100 - $231,200

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.

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.