Vertex · 4 hours ago
Associate Director, GMP Operational Quality (QA Ops for QC)
Boston, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$157K/yr - $235K/yr
7+ years expVertex Pharmaceuticals Inc is a global biotechnology company that invests in scientific innovation. The Associate Director, GMP Operational Quality is responsible for quality oversight of QC data review and supports the stability testing of Cell & Genetic Therapy products while ensuring compliance with regulatory requirements.
Computer Software
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
Qualification
Required
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
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)
Preferred
Master's degree or relevant comparable background
Benefits
Annual bonus
Annual equity awards
Overtime pay
Medical, dental and vision benefits
Generous paid time off (including a week-long company shutdown in the Summer and the Winter)
Educational assistance programs including student loan repayment
Generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex
Vendor intelligence that combs through your supplier, manufacturer, logistics data to detect where you're leaving money on the table.
2-10 employees
H1B Sponsorship
Vertex has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (27)
2024 (18)
2023 (7)
2022 (13)
2021 (5)
2020 (7)
Funding
Current Stage
Early StageCompany data provided by crunchbase