General Summary:
The Associate Director, GMP Operational Quality is responsible for oversight of 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 On-Site role is located at Vertex’s Leiden Center Building (LC1), 316-318 Northern Ave, Boston, MA-02210.
1st Shift B1: Wed to Sat 7:00am to 5:30pm
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 internally at Vertex manufacturing facilities.
- 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 to ensure the protection of subjects' safety, rights, and well-being as well as the integrity and credibility of data generated.
- Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to Good Clinical Practice (GCP).
- Liaise 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 collaborates with study team in development of 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, to ensure compliance to ICH GCP, applicable regulations, and company standards.
- For assigned programs/ studies, leads quality issue investigations, root cause analysis and CAPA development and assist 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/WI
- 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
- Develop and maintain QA to QA relationships with GCP Vendors to conform to quality agreements, and participate in applicable Vendor Joint Operating Committees, as needed.
- 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
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
- 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)
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:
1. **Hybrid** : work remotely up to two days per week; **or select**
2. **On-Site** : work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is on Vertex’s Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid
