We are seeking an experienced Senior Compliance Manager to support GMP compliance and inspection readiness within a regulated pharmaceutical environment.
Requirements
Desired Qualifications and Experience
* Ideally, 3-5 years’ 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 unit’s 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
Benefits
* 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