Associate Director, GMP Operational Quality (QA Ops for QC)

Vertex Inc.•Boston, MA

2d•Onsite

About The Position

General Summary: The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review for both non-routine and routine cGMP process testing and in support of stability testing of Cell & Genetic Therapy products. The role will also oversee team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams. This role requires collaborative interaction with cross-functional partners such as analytical and process development, clinical and commercial QC, and manufacturing operations to ensure the on-time closure of deviations, CA/PA, and change controls. This QA position will work with internal and external QA teams and QC labs ensuring adherence to compliance while supporting both clinical and commercial release and stability testing of a genetically edited cell therapy product. The position will provide compliance support to both clinical and commercial data review and data management. This person will support QA activities related to GMP release and stability as well as lifecycle improvement for methods related to raw material, in-process, and drug product samples. The GMP-facing nature of this work requires keen attention to detail and understanding of analytical compliance expectations.

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., QDoccs, Trackwise, Veeva)
Seven (7) + years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in cGMP related industry, with four (4) or more years of work experience in proven leadership/supervision and experience within a sterile manufacturing site and sterilization activities.
Knowledge of contamination control practices and engineering controls for cleanroom operations and critical systems (i.e., process air, water for injection, etc.)
Knowledge of standard microbiological procedures (sterility testing, environmental monitoring, bioburden, and bacterial endotoxin testing)
Must have experience in ethylene oxide, steam sterilization, and gamma radiation requirements.

Nice To Haves

Preferred Master's degree or relevant comparable background.

Responsibilities

Lead a Quality team: primarily responsible for providing quality oversight and support to business activities within purview at Vertex
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.
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 Performance Management (goals, monitoring, reviews); Monitoring /Supporting Employee Engagement and Retention; Succession Planning; Accomplishing staff results by communicating job expectations, planning, coaching, training and developing personal growth opportunities through IDPs.
Accountable to provide oversight of day to day team operations
Assists with workforce planning/resource modeling and to update through forecasting activities