Associate Director, GMP Operational Quality

General Summary

The Associate Director, GMP Operational Quality is responsible for overseeing team activities, developing personnel, and ensuring quality of deliverables within the department's purview. The incumbent has comprehensive knowledge of quality assurance and compliance principles and applications.

Key Duties And Responsibilities

• Leads a team in the Quality Operations organization responsible for internal commercial operations in support of GMP manufacturing and testing activities, including disposition of intermediates, working cell banks, and clinical and commercial drug products.

• Manages QA On The Floor and QA Walkthrough programs supporting Vertex GMP Facilities.

• Serves as the Quality Lead for assigned clinical programs, providing GCP compliance interpretation, consultation, and other support services necessary to maintain and/or improve the quality of Vertex research.

• Liaises with Vertex clinical functions and external parties including CROs, Vendors, and investigator sites to promote high levels of quality and consistency across and within programs.

• Provides QA review of protocols and participates on Operational Review Boards to identify operational risks and collaborate with study teams in developing risk mitigation strategies.

• Develops risk-based audit plans for assigned programs, ensures audits are conducted in accordance with the plan, reviews audit reports, evaluates responses and CAPA plans in accordance with company standards and policies.

• Manages and/or leads domestic and international audits for Clinical Investigators, ensuring compliance to ICH GCP, applicable regulations, and company standards.

• Leads quality issue investigations, root cause analysis, and CAPA development and assists study teams in implementing corrective and preventive actions in support of sustainable compliance.

• Contributes to the development and implementation of continuous quality improvement initiatives.

• Engages with study teams and functions for proactive inspection readiness across assigned programs.

• Provides inspection support as necessary for Regulatory Agency inspections held at Vertex facilities or Clinical Investigator sites.

• May serve as GCP Quality Management System representative.

• Participates in collaborative review of impacted SOP/WIs.

• Reviews and analyzes key Performance Indicator data and trends.

• Analyzes risk and proposes remedial, corrective, and/or preventive actions.

• May participate in process improvement initiatives.

• Develops and maintains QA to QA relationships with GCP Vendors to conform to quality agreements, and participates in applicable Vendor Joint Operating Committees, as needed.

• Affords support to 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)
  • Making sure employee engagement and retention are supported
  • Succession Planning
  • Ensuring staff results by communicating job expectations, planning, coaching, training, and developing personal growth opportunities through IDPs
  • Oversight of day-to-day team operations
  • Aiding in workforce planning/resource modeling and updating through forecasting activities

Knowledge And Skills

• 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;
• 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., QDoccs, Trackwise, Veeva).

Education And Experience

• 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

Pay Range

$156,600 - $234,800

Disclosure Statement

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family, and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental, and vision benefits to 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) and so much more. Flex Designation Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status In this Hybrid-Eligible role, you can choose to be designated as: Hybrid: work remotely up to two days per week; or select On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

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. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.