Job Title: Quality Management System and Audit Manager
Location: Hay on Wye
Reporting to: N/A
Responsible for (staff): QA Team
Relocate to the countryside
Enjoy green fields, fresh air and country leisure pursuits. Canoeing, horse riding, country pubs, antique shops, nature parks and a thriving market await the successful candidate.
PCI Pharma Services are an expanding, financially stable global organisation with ambitious growth plans. The company are very focused on the internal development of staff and Qualified Person (QP) training is available for the right person!
About the package:
Excellent salary with benefits + potential QP training support
About the Quality Management System and Audit Manager Role:
Challenging management position leading a team of five, responsible for compliance with quality management systems processes. Hosting and support customer and regulatory audits. Managing the internal audit program. Driving implementation and instigating improvements to quality systems.
As the Quality Management System and Audit Manager you will be responsible for:
- Auditing, management of commercial and clinical customer and regulatory audits.
- Supplier management, leading the supplier management program to including, auditing, agreements, risk assessments, supplier complaints and supplier performance.
- Quality management systems, control of QMS to include complaints, change controls, CAPA, QMR, GMP documentation, PQRs and internal audit program.
- Leadership, manage, mentor and develop a team of five, including conducting personal development reviews and appraisals.
About you and what you will need:
- Must have well developed management / leadership skills, with a proven track record of developing, mentoring and managing small teams in a challenging environment.
- A background in quality systems is essential, quality experience in a highly-regulated environment such as pharmaceutical, healthcare or medical would be preferred.
- Extensive customer facing experience is required.
- A degree level qualification in a scientific subject would be an advantage.
- Should be willing to undertake regular travel both within the UK and Europe.