Operational Area Quality Associate Director

Vertex Inc.•Boston, MA

24d•Hybrid

About The Position

General Summary: 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

Requirements

In-depth and specialized knowledge of both the conceptual and practical application of cGMPs in a pharmaceutical setting; in-depth knowledge of global GMP requirements and managing quality in support GMP manufacturing
Demonstrated success in building high-performing teams and skilled at managing team and individual development
Strong management skills with the ability to lead and motivate a team in a fast-paced environment while maintaining a high degree of quality, accuracy and timeliness
Substantial background in managing complex projects/teams within stated objectives and timelines and with a strong understanding of the underlying business drivers; skilled at applying project management processes / tools to lead meetings, assist with project planning, and facilitate attainment of project objectives
Ability to independently lead cross-functional teams and represent the interests, strategies and objectives of Quality unit
Strong skills in mentoring staff and transferring technical knowledge to enable their capabilities and development
Ability to communicate cross-functionally to a wide variety of audiences; exchanges complex concepts with the ability to influence leaders, customers, or vendors to adopt of a new point of view and/or to take action
Demonstrated ability to evaluate complex quality matters and make decisions utilizing risk-based approach; identifies and leverages the appropriate expertise to implement solutions
Substantial experience successfully leading event investigations, Root Cause Analysis (RCA), and CAPA
Extensive exposure with multiple regulatory agencies across applicable GxPs during inspections
Supstantial experience with electronic document management systems (e.g., Veeva)
Bachelor's degree in a scientific or allied health field (or equivalent degree)
Typically requires 8+ years of work experience and 2 years of management experience, or the equivalent combination of education and experience

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