Senior Quality Lead

United States of America, California, South San Francisco
United Kingdom, Welwyn

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Responsibilities

  • The PDQ Strategy Portfolio Lead is responsible for the determination of the Quality Assurance positions for a given area of the PDQ Strategy portfolio (GCP, therapeutic areas of the molecule pipeline – specifically early development)
  • Deliver the PDQ Strategy in assigned enterprise/therapeutic area through defined QA positions aimed at ensuring successful Health Authority engagement, including getting prepared for and hosting/supporting inspections
  • Establish strong partnership/relationship with business stakeholders (internal and external) and seek to understand and evaluate their priorities, develop the frequency and how best to check-in to stay on top of changes, which then inform your strategy
  • Continuously determine the prioritized PDQ activities (to include but not limited to; QA programs, training focus, process improvement, Affiliate visit focus, data analytics) which requires the delivery of evidence against the defined QA positions
  • Synthesize the results of this evidence against the stated target positions (spending time with the PDQ staff delivering the strategy for your area, understanding their outcomes and building this into the narrative of your positions)
  • Contribute to the development and execution of PDQ goals and initiatives
  • Maintains highest level of awareness and expertise in GxP regulations and internal policies and SOPs
  • This position will focus on determining QA positions for early development, including both GCP and GLP focus areas.  This is an exciting position to stretch your abilities, to be accountable for the QA positions and to create an amazing and impactful outcome, helping our patients, get our products faster.

Education/Qualifications

  • Masters, Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training and experience
  • Advanced degree in referenced fields preferred

Minimum Requirements

  • Minimum 7 years in pharmaceutical industry and/or quality assurance
  • Minimum 5 years in GCP/GLP related discipline
  • Demonstrated applied knowledge of clinical and regulatory requirements, as well as analytical, organizational and planning skills
  • Project management experience with proven leadership, mentoring and coaching

Desired

  • Proficiency in GLP/GCP regulations
  • Experience supporting regulatory authority inspections
  • Ability to formulate clear business questions that can be answered with data
  • Proficiency in utilizing data and visualization tools to generate insights

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