R&D Quality Manager
Essential Job Functions
- To oversee all QA activities from cell banking through to final release to clinical trial sites
- Liaise with CMC project teams to ensure timely delivery of clinical trial supply materials
- Provide CMC teams with information and guidance on Quality related issues
- Prepare, manage and execute QA project plans
- Prepare, or oversee management of, Product Specification Files
- Review and approve Quality documentation relating to manufacture, testing and release of materials to be used in pre-clinical or clinical trials where appropriate, including those arising from validation and tech transfer activities
- Provide quality oversight for complex development supply chains encompassing internal and external suppliers of raw materials, drug substance and drug product manufacture and testing related to clinical trial supplies:
- Provide Quality input into supply chain activities such as approval of new suppliers, raw materials, components, subcontractors
- Liaise with third parties over QA related project matters, including preparation of QA agreements. Ensure third party QA related requests are reviewed and incorporated into appropriate documentation where required.
- Act as person-in-plant for manufacture/testing activities performed at subcontractors, where required.
Skills, Knowledge and Personal Attributes
- Attention to detail
- Appreciation of need to comply with regulatory requirements
- Good organisational skills
- Excellent communication and interpersonal skills, with the ability to provide support to other teams in meeting the commitment to cGMP and patient safety.
- Keenness and ability to assimilate information for new Investigational Medicinal Products and apply relevant product quality specifications and in process controls.
- Some flexibility in working hours.
- Good knowledge of IT systems.
- Ability to work to written systems, and a methodical approach to performing duties.
- Helpful attitude, highly motivated team worker.
- Required: demonstrable ability to follow written procedures and to evaluate systems and records.
- Preferred: experience in Pharmaceutical Quality systems.
- Strong technical expertise in pharmaceutical validation
- Ability to travel both nationally and internationally up to 20% of working time
Relevant experience within a Pharmaceutical R&D or commercial environment with a bachelor’s degree or equivalent in Biology, Chemistry or Health Related Science.
- Experience in pharmaceutical Quality related role in a relevant pharmaceutical manufacturing environment.
- Experience in quality systems, quality methods, statistics, product qualification/validation, and a basic understanding of clinical product supply requirement
- Eligibility to act as a QP / trainee QP would be an advantage.
- Evidence of a high level of proficiency with IT Systems.