Vertex Pharmaceuticals · 2 weeks ago
Operational Area Quality Associate Director
Boston, MA
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $231K/yr
8+ years expVertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation. They are seeking an Associate Director, GMP Operational Quality who will provide primary QA oversight of commercial drug substance manufacturing and support for drug product manufacturing vendors, ensuring compliance and quality alignment. The role involves collaboration with business partners, oversight of vendor performance, and mentoring team members.
BiotechnologyHealth CareMedicalPharmaceutical
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
Qualification
Required
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
Substantial 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
Benefits
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
A generous commuting subsidy
Matching charitable donations
401(k)
Company
Vertex Pharmaceuticals
Vertex Pharmaceuticals is focused on the discovery and development of small molecule drugs for the treatment of serious diseases.
5001-10000 employees
H1B Sponsorship
Vertex Pharmaceuticals 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 (188)
2024 (150)
2023 (111)
2022 (164)
2021 (112)
2020 (80)
Funding
Current Stage
Public CompanyTotal Funding
$657.31MKey Investors
Janssen Belgium
2024-07-10Post Ipo Secondary· $1.11M
2022-05-17Post Ipo Equity· $50M
2009-12-03Post Ipo Equity· $443M
Leadership Team
Reshma Kewalramani
CEO and President
Nina Devlin
Senior Vice President, Chief Communications Officer
Recent News
2026-01-05
Company data provided by crunchbase