Job Description

The Senior Director, GMP Operational Quality Assurance will be responsible for the oversight of Site Quality Operations for the Manufacturing of Cell & Gene products. The role will be responsible for leading the Quality on site operations team across multiple shifts for internal clinical and commercial manufacturing operations. Responsibilities include day-to-day operational quality oversight for internal batch record review, batch disposition and manufacturing operations across the end-to-end manufacturing processes for the manufacture of clinical and commercial intermediates and drug product batches.

Responsibility includes ensuring all shift quality operational activities are completed in time by identifying technical risks and mitigations, participation in governance committees and improvements to the disposition process.

This is an onsite role, 5 days in a week at the Leiden Center, Vertex Pharmaceuticals, Seaport, Boston.

Key Duties and Responsibilities:

• Directs multiple teams responsible for internal commercial and clinical operations in support of GMP manufacturing and testing activities, including disposition of intermediates, clinical and commercial cell therapy products internally at Vertex manufacturing facility.

• ​Responsible for clinical and commercial batch release, for US, Canada, UK, EU and ROW markets including liaising with QP certification and importation requirements where applicable.

• Monitors operational activities and assesses continuous improvement within the QA operations.

• Proactively identify trends/gaps/risks and implement plans to mitigate such trends/gaps and risks.

• Leads Material Review Board (MRB) discussions, as necessary in case any quality event

• Ensures quality staff assesses and approves change controls for commercial processes for assessment of lot disposition processes.

• Leads and manages highly complex projects/teams within corporate objectives and project timelines

• Provide support/lead or assist with preparing for and hosting partner audits and regulatory agency inspections.

• Responsible for team development Lead, develop, and implement Quality strategy and compliance principles throughout product lifecycle management within the Cell & Genetic Therapies product portfolio

Knowledge and Skills:

• In depth experience in all stages of clinical product development to commercialization product life cycle management.

• Direct experience with regulators (e.g., BLA, MAA submissions and/or inspections).

• Ability to lead improvement projects - experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.

• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.

• Ability to apply critical thinking and problem solving skills to decision making and operational priorities.

• Strong leadership and an innate ability to mentor, collaborate and build relationships

• Demonstrated influential leadership experienced operating in a matrix organization through presenting, influencing, negotiation and partnering is required. Capable of building alignment across diverse perspectives and functional areas.

Education and Experience:

• Bachelor's degree in an engineering/Lifesciences field.

• Master's degree or relevant comparable background.

• Typically requires 15+ years of onsite relevant industry experience in quality assurance operations

• A minimum of 10 years leadership experience leading teams or directing allocation of resources is preferred. Previous experience on a Site Leadership Team is strongly preferred

#LI-AR #LI-Onsite

Pay Range:

Disclosure Statement:

The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Flex Eligibility Status:

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

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com