Associate Director, GMP Operational Quality

Vertex Pharmaceuticals•Boston, MA

6d•Onsite

About The Position

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

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)

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