Associate Director, Tech Transfer and Process Validation Operational QA

Job Description

General Summary:

The Associate Director for Tech Transfer and Process Validation Operational QA is a technical expert in the principles and application of Quality Assurance and compliance, specifically in process validation and technical transfers.  The Associate Director will provide compliance oversight for tech transfer and process validation activities across the Small Molecule portfolio. This position will have a broad role working with stakeholders across MS&T and External Manufacturing as well as various Quality functions (Development and Commercial Operations, Product Quality. Compliance, etc.). The Associate Director provide Quality leadership for new and multiple projects, effectively ensuring alignment with corporate goals and compliance with all regulatory requirements. 

This position is a Hybrid Role based out of the Boston office and reports to the Senior Director, GMP Operations Quality. The successful candidate will ensure timely delivery to support the business goals, mentor team members to provide individual development in addition to efficient and valuable service to project teams.

Key Duties and Responsibilities:

• Establishes Quality technical expectations and ensures quality oversight and support to Validation and Tech Transfer manufacturing operations within Vertex or at contracted suppliers 
• Ensures Validation strategy for new products and second sources to comply to regulations and risk mitigation strategies
• Lead Change Control expectations ensuring compliance to change procedure requirements
• Lead escalation investigations and communication with leaderships for alignment and execution of endorsed action plans. Ensures assessment on Validation activities
• Responsible for developing process for product knowledge transfer to the Quality Operations team
• Establishes and enforces Quality Agreements between new CMOs/Suppliers and Vertex, as needed
• Initiates strategy for onboarding of Qualified vendors through the establishing of Quality Operations oversight
• Ensures Preapproval Inspection Readiness activities by collaborating with the Compliance team and contracted suppliers
• Communicates and monitors risks and risk mitigation plans as necessary 
• Identifies topics requiring Inspection Storyboards
• Provides technical advice for regulatory agency audits
• Provides leadership and partners with QA management in proactive and strategic planning for QA and translation of the strategy to technical transfers and process validation for execution
• Develops plan and leads Quality team to enable support for future small molecule portfolio advancement
• Collaborate as Leadership Team member of the Small Molecule External Manufacturing Operational Quality
• Responsible for the development of the team and individual team members. - -
• Business travel can be up to 25% of time

Knowledge and Skills:

• Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance and effectiveness
• Experience providing Quality support and oversight of GMP manufacturing operations for validations and tech transfers
• Experience with drug substance and drug product (oral solid dosage forms preferred) development and manufacturing with proficient knowledge in a pharmaceutical setting
• Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment
• Broad and deep operational and project management knowledge and experience
• Demonstrated strategic planning and execution skills required 
• Proven ability to design/evolve and /or implement quality strategies and operational planning and oversight in a fit-for-purpose manner enabling effectiveness, flexibility and adaptability in a dynamic and evolving business model
• Proven team leadership skills with the ability to work in a fast-paced environment and meet quality, accuracy and timeliness objectives
• Excellent leadership of complex projects/teams; effectively applies project management processes / tools to lead meetings, assist with project planning, and facilitate completion of tasks
• Ability to independently lead and drive cross-functional teams and represent the Quality unit
• Ability to communicate cross-functionally to leadership; exchanges complex and sensitive information
• Developing individuals and teams; proven leadership capabilities within multi-level organization  
• Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
• Excellent communication skills and a proven track record Influencing/b