Job Description

General Summary:

The Vendor Quality Management Director provides technical and strategic leadership for vendor quality, vendor quality processes, and associated governance for the cell and gene therapy business unit. This position focuses not just on the "what" but the "how", ensuring phase appropriate and risk based compliance.

**This is a hybrid role located in our Seaport offices.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Management of vendors and vendor process including onboard, risk based and phase appropriate qualification oversight, and ongoing monitoring.
• Monitors health of vendor quality management system as well as vendor performance through audits, inspections, SCARs, and other inputs. Ensures escalation and increased governance of low performing vendors and tracks the risks and mitigation plans.
• Work with global quality and functional areas to ensure vendor qualification program is scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations
• Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation within corporate objectives and project timelines
• Provide technical and strategic support to functional areas including other quality groups for vendor related issues
• Identify ways to improve efficiency and effectiveness of processes
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: vendor management, risk management, auditing techniques, and quality governance
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific or allied health field (or equivalent degree)
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

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