R&D QA Manager / QP - Cheshire - Pharma/Medical Devices
Salary: Circa 75k
Purpose of Role
To lead the R&D Quality Team to provide oversight and support to the New Product Development and Technical Support functions to ensure that new products are developed and projects and processes are introduced to the respective manufacturing site in compliance with current Good Manufacturing Practices. To act as a Qualified Person under EU directives for Investigational Medicinal Products.
Key Results Areas
Knowledge, Skills and Competencies
Must have a degree in a relevant science discipline.
Qualified Person under EU directive, eligible to release Investigative Medicinal Products.
Previous experience in a Quality Leadership role with previous experience operating as a Quality Assurance Manager in a modern manufacturing/R&D environment within the pharmaceutical industry.
Experience in steriles operations to EU and FDA standards.
Experience of new product introduction from development to final approval.
Experience with reviewing and assessing the suitability of new product licence dossiers/submissions.
Experience with Regulatory inspections (either hosting or being a key presenter).
Knowledge base expected of a QP, with special emphasis on the development and manufacture of sterile products.
Strong leadership skills with the ability to influence standards of behaviour and ways of working which contribute towards compliant and on time NPD operations.
Ability to objectively review a wide range of technical data and feed back problems and concerns in a constructive manner.
Ability to present information to and influence external auditors.
Ability to coach, train and develop team members.
QP / QUALIFIED PERSON / QA MANAGER / HEAD OF QA / QC MANAGER / MANAGERIAL / TECH TRANSFER / TECHNOLOGY TRANSFR / DRUG DELIVERY / INJECTABLES / STERILES / STERILITY / COMBINATION DEVICES / MEDICAL DEVICES / PHARMA / PHARMACEUTICALS / GMP / ENGINEERING / MANUFACTURING / PROTOTYPE / MANUFACTURING / PRODUCTION / REGUALTORY / CLINICAL / COMPLIANCE / R&D / PRODUCT DEVELOPMENT / DESIGN / ENGINEER / SCIENTIST / CHESHIRE / CHESTER / DERBY / DERBYSHIRE / MANCHESTER / LANCASHIRE / LANCASTER / LIVERPOOL / NORTH WALES / UK / UNITED KINGDOM / RELOCATE / GSK / GLAXO / BESPAK / ASTRA ZENECA / NOVARTIS / QAIGEN / PFIZER / SANOFI / PRODUCT DEVELOPMENT / ENGINEER / ENGINEERING / CLINICAL / REMEDIATION / PACKAGING / SCIENTIST / SCIENTIFIC / BIOMEDICAL / MEDICAL / HEALTHCARE / REGULATORY AFFAIRS / QA / QUALITY ASSURANCE / FORMULATION / AUDITING