Associate Director, GMP Operational Quality (Hybrid)

General Summary:

The Associate Director, GMP Operational Quality isan advanced technical resource and is recognized as an expert internally in the principles and application of quality and regulatory compliance. The individual adapts to new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements.

The Associate Director is responsible for management of CDMO performance and commercial product disposition, including management of direct reports to execute the team's responsibilities. The role is responsible for coordinating and/or executing activities on multiple complex projects and takes a role in the design and execution of new projects. The Associate Director will be the Quality Operations point of contact for a disease portfolio involved in strategic product decisions and escalations, as necessary.

The Associate Director manages and develops personnel to support department and functional activities. This position reports directly to the Sr. Director of GMP Operational Quality and is based onsite at our Boston, MA offices (3 days/week).

Key Duties and Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

• Lead strategic quality oversight of operations at external manufacturing sites in alignment with the Vertex corporate Quality strategy

• Lead Quality team providing project oversight of CDMO operations; responsible for driving improvements at the sites and monitoring performance to Quality Agreement expectations.

• Establish and revise Quality Agreements in collaboration CDMOs

• Engage in Quality-to-Quality Meetings

• Collaborate with internal and external partners to resolve complex quality issues to ensure compliant solutions

• Identify and escalate Quality events and communicate risks; oversee and assist risk mitigation plans as necessary

• Supports audit and inspections at CDMOs; ensures proper and timely CAPA for observations

• Drives performance through reporting and monitoring KPIs and metrics in collaboration at Operational review

Lead and develop team to deliver on the following responsibilities:

• Commercial drug product disposition

• Collaboration in cross-functional teams as an experienced Quality technical resource

• Drafting and enforcing Quality Agreements between CMOs/Suppliers and Vertex, as needed

• Assisting Change Control owners with ensuring compliance to procedure, assessing and approving change controls

• Conducting quality investigations /deviations and reviewing corrective action plans for adequacy and compliance. This includes root cause analysis and product impact assessments for investigations resulting from deviations and OOS.

• Ensuring appropriate and timely CAPA actions.

• Identifying, facilitating, and/or leading continuous improvement efforts

• Maintaining Quality Metric data to support process improvement activities

Responsible for the following activities related to people management responsibilities:

• Talent Acquisition/ Recruiting/Interviewing/ Selection/Onboarding

• Performance Management (goals, monitoring, individual development, training, performance reviews)

• Accountable to provide oversight of day-to-day operations. Assists with workforce planning/resource modeling and to update through forecasting activities.

• Provides information to assist in budgeting and scheduling

• Travel requirements up to 25%

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

• Substantial experience with electronic document management systems (e.g., 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

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