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Associate Director Quality, Operational Excellence & Complaints, Cell & Gene (Hybrid)

Semma Therapeutics

Semma Therapeutics

Quality Assurance
Multiple locations
Posted on Wednesday, June 26, 2024

Job Description

The Quality Operational Excellence and Complaints Associate Director provides technical and strategic leadership to drive strategic change and improve operational efficiency within the cell and gene therapy business unit. This position focuses not just on the “what” but the “how”. This role will also be responsible for the complaints process.

Key Duties and Responsibilities:

  • Collaboration and Integration: Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing. Develop partnerships across the organization to drive collective learning.
  • Drive performance optimization, continuous improvement, and operational excellence. Apply expertise to develop solutions, streamline operations, and enhance productivity.
  • Responsible for all activities associated with the product complaint process, including reconciliation training, complaint sample management, triage, trending, and SOP management, etc.
  • Processes incoming clinical and commercial production complaints including intake, initial evaluation, and triage. Coordinates with CMOs for external investigations including root cause analysis and corrective actions.
  • Work with global quality and functional areas to ensure processes are scalable and flexible including integration of new modalities into the quality systems as Vertex expands its scope of operations.
  • Proactively identify ways to improve efficiency and effectiveness of processes which may include quality system process improvements, improving existing methodologies, data generation, report development and presentation

Requirements:

  • Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field
  • Typically requires 8 years of experience or the equivalent combination of education and experience
  • Continuous improvement experience such as six sigma or lean
  • Strong technical knowledge including but not limited to: complaint process, risk management, and quality governance
  • Ability to understand and translate customer needs
  • Proven ability to lead improvement projects and project teams and organize various teams and forums
  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
  • Proven ability to identify and analyze performance indicators.

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-ND2

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