We are seeking an experienced Senior Compliance Manager to support GMP compliance and inspection readiness within a regulated pharmaceutical environment.
Desired Qualifications and Experience
- Ideally, 3-5 yearsβ experience in the GMP pharmaceutical business
- Experience in a quality and/or QC function
- People management and leadership experience
- Relevant degree
- Comfortable working in a dynamic and changing environment.
- Appointment to this role is subject to the receipt of a satisfactory Enhanced DBS check.
Key Responsibilities
- Ensure compliance with EU/UK GMP and Isle of Man regulatory requirements
- Line management of the QA, QC, and R&D functions
- Mentorship and performance management of direct reports
- Effective planning and organisation of the unitβs day-to-day activities in collaboration with the other business units.
Quality
- Enforcement of GMP practices throughout the business
- Generation and implementation of GxP documentation and protocols where required
- SME in GMP standards and any inspections or internal quality event investigations
- Identifying and raising deviations, participating in root cause analysis, and implementing CAPA plans.
Communication
- Working closely and communicating effectively with the Growing and Production units
- Tracking of key metrics and sharing with other functions and the senior management team
- Cascading key information and strategy from the senior leadership team to the quality and technical unit.
Health and Safety
- Ensuring compliance with safety regulations and company policies
- Reporting near misses, accidents, and incidents in a timely manner.
- Controlled Drugs
- Following company and HO procedures for the handling and destruction of controlled drug material
- Salary depending on experience
- 25 days annual leave + Bank Holidays
- Full-Time role (Part-Time considered)
- Opportunity to live and work on the Isle of Man
- Relocation package available