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Senior Director, Product Quality Lead Cell and Gene

Semma Therapeutics

Semma Therapeutics

Product, Sales & Business Development, Quality Assurance
Boston, MA, USA
Posted on Thursday, June 27, 2024

Job Description

The Senior Director of Product Quality is accountable for end-to-end quality oversight of cell and genetic program throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This oversight includes setting and maintaining overall oversight of Quality strategies, and product life cycle in support of commercialization efforts. This includes 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 lead a team and 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, and implement Quality strategy and compliance principles throughout product lifecycle management within the Cell & Genetic Therapies product portfolio
  • Lead, develop & implement 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 manufacturing 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 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 across a product life cycle to assure a compliant strategy is developed, executed and maintained.
  • Chair/Lead 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.
  • Prepare, maintain and manage to budget allocation.

Required Education Level

  • Bachelor's degree in an engineering/Lifesciences field.
  • Master's degree or relevant comparable background.

Required Experience

  • Typically requires 15+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
  • A minimum of 10 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

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.

Other Requirements

Up to 15% travel

On-Site Roles

On-Site designated role, you will work five days per week on-site with ad hoc flexibility.

#LI-Onsite #ND-2

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