Director R&D Quality (R&D and Early Discovery)

Director R&D Quality (R&D and Early Discovery)

GW Pharmaceuticals

Cambridge, United Kingdom

About the role

To provide phase-appropriate quality oversight and support to internal and external drug discovery and early phase development activities, including non-clinical development.

Essential Responsibilities

  • To ensure the implementation of the global Quality strategy, as relevant to the early phase discovery and non-clinical R&D activities;
  • To develop and support initiatives to enhance/improve phase appropriate GxP compliance within R&D early phase discovery and non-clinical and to drive continuous improvement;
  • To ensure preparedness within the R&D and preclinical groups for inspections, including identification of compliance vulnerabilities and to assist in developing responses for inspectional observations;
  • To interpret, communicate and implement changes in GxP, ICH and compliance related regulations, standards and practices, as related to early development;
  • To develop and initiate efforts designed to constantly improve and globally harmonise R&D CMC processes and systems;
  • Promotes a product understanding and risk-based approach to R&D discovery activities, ensuring that Quality Risk Assessments are performed and documented, identifying appropriate Critical Quality Attributes and Critical Process Parameters;
  • Achieve financial objectives by preparing the R&D Quality budget, scheduling expenditures; analysing variances and initiating corrective actions;
  • Contributes to Global Quality strategic projects as a member of the Global Quality Leadership Team;
  • Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participating in professional societies;
  • Travels to locations as needed, to facilitate/coordinate activities, resolve issues, etc.

Required Knowledge, Skills, and Abilities

  • Excellent organizational, verbal, communication and presentation skills;
  • Ability to effectively lead and participate on multi-disciplinary teams;
  • Ability to work independently with minimal direction;
  • Ability to develop and manage a high performance team focused on accountability and meeting/exceeding expectations;
  • Ability to lead, influence, create and work within a multi-functional environment;
  • Assertive, proven manager with a strong results orientation and sense of urgency;
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and pharmaceuticals;
  • Ability to apply cGxP regulations and other FDA and international guidelines to all aspects of the position.

Required/Preferred Education and Licenses

  • BSc in life sciences or related discipline. MSc or PhD preferred;
  • Extensive experience in pharmaceutical industry, including a senior leadership position within the bio/pharmaceutical industry;
  • Prior experience of working in bio/pharmaceutical R&D;
  • Extensive experience in GxP regulatory compliance requirements, as they relate to early phase development;
  • Experience in strategic planning and collaboration with executive and key operational groups;
  • Progressive and proven track record of leadership and managing quality in a global organization.

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© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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