About the role
Function of department
The Business Integrity Unit (BIU) ensures the highest standards of honest, ethical and transparent behaviour are engaged in and adhered to across all Crown Agents operations.
Main job purpose
Reporting to Head of BIU or alternate as necessary, As Healthcare Compliance Manager, you will be responsible for ensuring medical healthcare compliance, including Good Distribution Practice, Medical Device Regulations (MDR), within Crown Agents’ Quality Management Systems.
Main responsibilities of the job
Product Integrity for Medicinal Supply Chain
- Ensures that key compliance standards are met by offering effective service provision to all Crown Agents’ offices and projects.
- Ensures that Crown Agents maintains Good Distribution Practice in all relevant medicinal supply chain projects.
- Manages CA’s Wholesale Distribution Authorisation Licence issued by the Medicines and Healthcare Products Regulatory Authority and our United Kingdom Controlled Drug Licence issued by the Home Office
- Assumes the position of ‘Responsible Person’ for Good Distribution Practice (GDP) compliance.
- Responsible for implementing all statutory requirements related to Crown Agents’ Wholesale Distribution Authorisation (WDA) Licence and Controlled Drug Licence.
- Takes responsibility for all MHRA and Home Office audits and licence renewal.
- Provide technical procurement inputs to projects, including advice on GDP and also assistance with specification writing and technical evaluations of bids.
- Promote compliance awareness across the company worldwide
- Maintain up to date Pharmaceutical and Freight industry knowledge, keeping abreast of hot topics and challenges
- Monitor regulatory environment and report changes in Quality and Regulatory compliance requirements
- Work with key customers and supply chain teams to develop optimum continuous improvement solutions to defined requirements that add value to the current relationship, improve margin returns and ensure client retention
- Be aware of and adhere to company quality standards and procedures in accordance with Crown Agents’ commitment to working to the highest quality standards and striving for continual improvement
- Be aware of and compliant with all the standards following Safeguarding procedures and policies.
- Promote Crown Agents’ speak up culture in order to protect the welfare of children, young people and vulnerable adults
Any other duties as appropriate to the position, as requested
- UK qualified pharmacist or equivalent
- Prior experience of working as an RP (responsible person)
- In-depth experience of Quality within Pharmaceuticals and Medical Devices, with a thorough knowledge of GDP
- Excellent understanding of MHRA and ISO 9001 Quality Management Systems requirements
- Qualified as a Responsible Person for a Wholesaler (medicinal) Licence
- Experience in dealing with MHRA required, experience in dealing with other regulatory bodies, e.g. EMA, FDA would be desirable
- International Supply Chain and Quality background
- Pharmaceutical, and developing/emerging market supply chain experience preferable
- Experience in managing sub-contract operations to regulatory standards
- Experience of support new business opportunities within the health supply chain sector (i.e. bid support)
- Project and Time Management skills
- Experience hosting customer audits and Defined Regulatory Authority (DRA) regulatory inspections
- Analytical and problem-solving skills
- Facilitation and coaching skills
- Ability to roll-out cross-regional and cross-functional initiatives
- Willingness to travel internationally as necessary
About what’s on offer
Crown Agents offers a competitive package