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