Senior Director, GMP Operational Quality (Hybrid)

Job Description

General Summary:

The Senior Director, Operational Quality is responsible for the Quality oversight of External Manufacturing operations for all Vertex Small Molecule programs, development and commercial. This is a critical role within Quality department responsible for developing and managing CDMO Quality relationships. The Sr. Director will also work closely with internal business stakeholders from Pharmaceutical Sciences, Commercial Manufacturing and Supply Chain as well as internal Quality functions to deliver quality outcomes.

The Sr. Director is responsible for oversight of department activities, development of personnel and ensuring the quality of deliverables within the role's purview. The incumbent is known for significant technical expertise and establishes the strategic alignment of group and department goals with its projects and activities, refining and adapting as necessary through proactive monitoring/measurement.

This position will be based in Vertex's corporate headquarters in Boston, MA.

**This is a hybrid role working 3 days on-site and up to two days remotely.**

Key Duties and Responsibilities:

• Ensure organization design, resources, capabilities, and processes are built to support the Vertex Small Molecule business needs.
• Responsible for oversight of external quality operations in support of GMP manufacturing (Development and Commercial) activities.
• Quality support of Tech Transfer and Process Validation activities
• Disposition of batches
• Responsible for Change Management to ensure proper evaluation of process related changes and to ensure compliance to Regulatory filings.
• Oversight of CDMO performance to compliance and Quality Agreement expectations. Establish Quality leadership engagement to deliver on expectations and process performance evaluations. Drive Quality operations messaging for Business Review Meetings.
• Drive Continuous Improvement through Operational Review and improvement initiatives. Responsible for leading and advancing Operational Review, a key element of Quality Governance model. Establish KPIs to drive behaviors within External Operations.
• Collaborate with cross functional Quality (Inspection Management, Compliance, International) and CDMO management to ensure pre-approval inspection and commercial readiness activities at the CDMOs. Adjudicate on compliance discussions and negotiate any required corrective actions.
• Create and foster a culture of collaboration and engagement for advancing quality outcomes and operational excellence.
• Lead team members, support development of organizational capabilities and talent development.
• Business travel up to 15% of time

Knowledge and Skills:

• Successful strategic leadership experience
• Successful people development and building/leading high efficiency teams experience .
• In-depth global health regulatory agency knowledge and experience across GxP life cycle in small molecules, devices and combination products preferred.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
• Broad technical knowledge in across product modalities, different types of processing and testing.
• Current knowledge of industry trends and best practices.
• Excellent communication skills and a proven track record influencing/building/promoting a culture of quality and excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical thinking and problem-solving skills

Education and Experience:

• Bachelor's and Master's degree in a Scientific/Technical/Business discipline.
• 15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Hybrid-Eligible Roles

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.

#LI-Hybrid #LI-ND2

Company Information