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 will 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 with regulations and risk mitigation strategies.
• Lead Change Control expectations ensuring compliance with change procedure requirements.
• Lead escalation investigations and communication with leadership 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 a multi-level organization.
• Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness.
• Excellent communication skills and a proven track record influencing / building / promoting a culture of Quality and Excellence.

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.

Flex Designation :

Hybrid-Eligible or On-Site Eligible

Flex Eligibility Status :

In this Hybrid-Eligible role, you can choose to be designated as :

Scroll down the page to see all associated job requirements, and any responsibilities successful candidates can expect.

1. Hybrid : work remotely up to two days per week; or select

2. On-Site : work five days per week on-site with ad hoc flexibility.

Note : The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

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