Associate Director, GMP Operational Quality (Hybrid)

Job Description

General Summary: 

The Associate Director, GMP Operational Quality is an 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  

• Performan