Vertex Pharmaceuticals

Job Description

The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel and ensuring quality of deliverables within department purview. The incumbent has comprehensive knowledge of principles and application of quality assurance and compliance. The incumbent is responsible for development of group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements, refining goals and projects when necessary. The incumbent not only coordinates group responsibilities to ensure timely delivery to support business, but mentors team members to provide individual development in addition to efficient and valuable service to project teams.

Key Duties & Responsibilities

• Lead and/or participate in the development and implementation of Quality analytical compliance principles throughout product lifecycle management within the Cell & Genetic Therapies product portfolio
• Lead and/or participate in the development and implementation of CMC and Analytical Quality standards for products and processes for stage gate deliverable, embedding the principles of product lifecycle and Quality by Design.
• Proactively maintain Quality Assurance oversight for analytical development, and qualification activities for the applicable methods/program.
• Work with cross-functional partners for the risk identification, resolution of issues, OOS, and risk /gap mitigation.
• Responsible for the QA oversight of the stability program to assure compliance with internal Vertex procedures and EU/US regulatory standards. Ensure compliance with cGMPs.
• Ensure quality and compliance frameworks, guidance, and systems are in place to keep the products current with industry and health authority regulatory expectations as well as Vertex’s QMS for products throughout the life cycle development.
• Work with development functions and commercial supply chain to drive analytical and compliance continuous improvements throughout the clinical development to commercial life cycle.
• Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of development. Partner with stakeholders to mitigate the identified risks and implement associated actions throughout product life cycle.
• Participate in appropriate governance meetings for Quality members to critically review proposed complex changes, assure compliance to regulatory requirements, and drive standardized processes across sites.
• Support OOS investigations, preparation of specifications, CMC clinical and commercial regulatory submissions.
• Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
• Lead and mentor team members, support development of organizational capabilities and talent building.

Knowledge and Skills:

• In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.).
• In depth experience in all stages of clinical product development to commercialization product life cycle management.
• Direct experience with regulators (e.g., NDA, BLA, MAA submissions and/or inspections).
• Broad technical knowledge in analytical development, method validations, method transfers, etc.
• 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 a biotech/Lifesciences field.
• Master's degree or relevant comparable background.
• 8+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

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

2. On-Site and work 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Pay Range:

$154,100 - $231,200

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:

Hybrid-Eligible Or On-Site Eligible

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