Head of Quality Operations - EML
Proclinical are seeking a Head of Quality Operations to join a dynamic and talented team in England. The Head of Quality Operations will be expected to review and disposition batches for marketed products in accordance with the UK Code of Practice for Qualified Persons on behalf of the company.
- Perform QA review and approval of master and executed batch records and associated documents.
- To support the ongoing compliance of the EML facility. Including implementation of new GMP requirements. Raising initiatives to improve compliance with current GMPs. Ongoing training, coaching and mentoring of EML staff in GMP and compliance.
- To write, review and approve SOPs.
- To participate in the execution of the internal and external audit process according to the audit schedules.
- To support the Quality Operations Senior Director EMEA in the preparation and management of third party audits and competent authority inspections.
- To review and approve Quality Agreements and Product Quality Review.
- To review and approve deviations and customer complaints, and support with their associated investigations and CAPAs.
- Assessment of change controls.
- To review and approve qualification/validation protocols and reports.
- To participate, when required, in the testing of the effectiveness of EML's EU product recall procedures on an annual basis or product recall.
- Support EML projects where required.
- Initiate and support EML continuous improvements.
- Support EML management review meetings.
Skills and Requirements
- Demonstrable Leadership and people management skills
- Problem solving and decision-making capabilities
- Ability to drive and lead organisational change
- Professional behaviour and self-awareness, diplomatic,
- Ability to build, motivate and develop high performance teams
- High level of self-awareness and ability to influence
- Auditing skills, appropriate qualifications in auditing an advantage.
- Proficient in English, fluency in other languages is advantageous.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.