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Director, Product Quality Cell and Gene (Hybrid)

Semma Therapeutics

Semma Therapeutics

Product, Quality Assurance
Boston, MA, USA
Posted on Wednesday, June 26, 2024

Job Description

The Director of Product Quality is has quality oversight of cell and genetic programs throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This oversight includes setting and maintaining overall oversight of Quality strategies, product project management in support of commercialization efforts including establishing relevant product quality standards for current or novel technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying product quality risks and mitigations throughout development for the assigned programs.

The role will closely partner with operational stakeholders to participate in Cell & Genetic therapies projects and associated governance to meet business, regulatory and operational requirements.

Key Duties & Responsibilities

  • Lead, develop & implement CMC Quality standards for products and processes for stage gate deliverable working in collaboration with key internal and external stakeholders, embedding the principles of product lifecycle and Quality by Design.
  • 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 to drive manufacturing and compliance continuous improvements throughout the commercial life cycle.
  • Proactively identify Quality risks and improvement opportunities for the assigned program(s) across all stages of manufacturing. Partner with stakeholders to mitigate the identified risks and implement associated actions throughout product life cycle.
  • Serve as the Quality SME on the Chemistry, Manufacturing, and Controls (CMC) Governance teams covering Analytical Development, Process Development, Technical Operations, and Supply Chain topics for technical transfers, new product introduction, clinical trial and commercial products to assure a compliant strategy is developed, executed and maintained.
  • Support preparation of 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.

Required Knowledge/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 AAV/Cell technology, aseptic processing, process & analytical development, manufacturing science & technology, 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 an engineering/Lifesciences field.
  • Master's degree or relevant comparable background.
  • Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment
  • A minimum of 3 years leadership experience leading teams or directing allocation of resources is preferred. Previous experience on a Site Leadership Team or R&D Leadership Team is strongly preferred

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-ND

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