Responsibilities:
- to support the Group with quality assurance, compliance and regulatory matters,
- to lead and manage the operational performance of the Quality Department ensuring the successful delivery of business strategy, KPI’s and objectives, whilst adhering to regulatory compliance and achieving commercial success,
- work closely with SMT members to ensure consistent management of the site, setting objectives and KPI’s for the quality function,
- oversee Quality Assurance activities; document control; compliance within the EQMS system,
- to support all Validation and Qualification activities,
- support the Quality Assurance review of both batch documents and Quality Control/Microbiological data to support batch certification,
- lead and conduct internal & external audits across the Group and its suppliers,
- to ensure the availability of adequate competent resources to carry out the activities required of the Quality team in accordance with site and GMP requirements,
- to develop and communicate realistic objectives and standards for the team, regularly checking progress,
- to motivate, support and develop employees to fulfil their roles,
- maintain an awareness of new and proposed legislation that impacts the business, communicate any changes to SMT in a timely manner,
- ensure appropriate investigation of discrepancies, errors, complaints, failures or adverse events requiring documentation are reviewed and actioned,
- to approve site GMP Refresher training.
Requirements:
- 8–10 years of pharmaceutical experience – ideally from another CDMO (contract development manufacturing or clinical or commercial packaging),
- scientific degree (ideally pharmacy, pharmaceutical sciences, biology, chemistry or related),
- experience in coordinating and participating in regulatory inspections,
- demonstrable track record and skills/experience gained within a similar position(s) at a similar level,
- previous experience in the pharmaceutical industry,
- desirable to be an eligible QP,
- fluent English - must have.
The offer:
- work in an international environment,
- the possibility of a real impact on the organization,
- development opportunities,
- salary commensurate with your skills.