Associate Director, Analytical Product Quality (Onsite)

Job Description

The Associate Director, Analyt

ical Product Quality is accountable for end-to-end technical quality oversight of cell and genetic QC analytical program throughout clinical development, commercialization, product launch and post approval lifecycle management activities. This includes establishing relevant analytical quality standards for current or novel analytical technologies, ensuring internal and cross-functional alignment with industry and regulatory expectations, and identifying analytical quality risks and mitigations throughout development for the assigned programs. The role will closely partner with Quality Control, Process and Analytical Development, and Manufacturing/MSAT to participate in Cell & Genetic therapies projects and associated governance to meet business, regulatory and operational requirements.

Key Duties & Responsibilities

·Lead the development and implementation of Quality analytical compliance principles throughout product lifecycle  within the Cell & Genetic Therapies product portfolio by applying experiences with ICH and other industry standards

·Lead 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 quality control laboratories during method qualification and validation activities.

·Work with cross-functional partners for the risk identification, resolution of issues, investigation of OOS, and risk /gap mitigation.

·Lead the development and implementation of training standards and best-practices involved with the QA oversight of QC laboratories, including but not limited to QA review, quality event and report technical writing

· 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 and ensure program is inspection ready.

·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 critical deviation and OOS investigations, preparation justification 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, DM