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Director Quality Operations

Semma Therapeutics

Semma Therapeutics

Operations, Quality Assurance
Multiple locations
Posted on Wednesday, May 17, 2023

Job Description

We are looking for a quality leader who will partner with our International Commercial and Supply Chain teams to support the distribution of Vertex’s clinical and commercial product portfolio. This leader will foster strong collaboration with these teams to define and implement our strategic approach for partnering with global distribution partners for all patient supply channels including distributors, 3PLs, wholesalers, home deliveries and various patient access programs. They will also be responsible for establishing the organizational structure and associated quality team, to manage these activities and ensuring quality of deliverables within their remit.

This candidate will ensure alignment with Quality leadership and other quality teams in development of integrated strategies for international expansions and sustained compliance across all affiliates, process and vendor oversight and assurance.

Key responsibilities:

  • Serves as the International Supply Chain and Distribution quality leader with accountability for strategic leadership and quality oversight for Distribution i.e., all routes to customer and patients for both clinical and commercial products
  • Provides strategic direction and oversight to development, execution and continual improvement of quality risk management/mitigation strategies to support the distribution of Vertex product portfolio
  • Responsible for the processes and systems to provide approval and quality oversight of all distribution partners such as 3PL, Transport & storage providers, Wholesalers, Distributors, importer & exporters etc.
  • Owner of the Global Materials Management Standard and the processes to proactively manage and report operational performance targets/goals for the distribution of all materials globally i.e., raw materials, intermediates and finished goods.
  • Serves as Quality representative to International commercial and clinical Supply chain organisation and supports them in establishing and maintaining Supply Chain maps for the global markets.
  • Responsible for the development and management of an effective global shipping qualification process inclusive of transportation lanes, modes of transport, risk assessments and data loggers
  • Partners with QPs and RPs across the regions to enable new product launches and effective quality governance of the in-region distribution of our products
  • Manages for cause, critical and/or complex quality issues in the distribution operations and supports CMC quality teams investigating any potential product quality issues arising within the distribution network.
  • Provides leadership for their team and partners with International and QA management in proactive and strategic planning for QA and translation of the strategy to operating plans for execution
  • Manages the international GDP management review process and the input into the local and global GDP and GMP management review processes.
  • Supports our in region quality teams in the inspection preparation and management, prior to, during and following any competent authority inspection of international locations.
  • Participates in geographic expansion activities with Commercial, Regulatory and Supply chain teams to ensure quality related requirements/actions are included and completed in line with commitments e.g. QMS build out, new distribution partner audits & QTA, new/variations to licences
  • Acts as the delegate for the International Head of Quality, when required.

Key requirements:

  • Significant experience in a senior quality leadership role in a pharmaceutical supply chain management and/or distribution environment.
  • Understanding of Gene and Cell or biological manufacturing and/or distribution environment.
  • M.S. (or equivalent degree) or B.S. in a scientific discipline.
  • Broad and deep global health regulatory agency knowledge and experience across multiple GDP/GMP with current knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.
  • Knowledge and demonstrated experience in application of risk-based quality principles in a pharmaceutical environment.
  • Demonstrated capability to lead a team through organisational change and a dynamic/ evolving business model.
  • Proven leadership ability to design/evolve and implement quality strategies to support their commercial and supply chain partners in both a clinical and commercial setting.
  • Proven leadership capabilities within multi-level organization and ability to foster exceptional collaboration across an international organisation.
  • Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
  • Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions



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