Healthcare Compliance Manager
A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Healthcare Compliance Manager to join their West London team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.
Purpose To provide oversight of and guidance on company processes related to the ABPI and IPHA Codes of Practice, supporting affiliate training and compliance monitoring activities, and identifying opportunities for continuous improvement.
- Identify process gaps and solutions by continual review of existing company healthcare compliance (HCC) processes (global, regional and local)
- Develop / maintain HCC Standard Operating Procedures (SOPs) in collaboration with the relevant internal stakeholders
- Develop and deploy a Continuous Process Improvement Plan: Define, manage and monitor Code of Practice-related Corrective and Preventative Actions, Compliance Incidents and root cause analysis, and Change Controls in collaboration with the Quality team
- Perform regular monitoring checks/self-audits to ensure compliance with internal procedures and Codes of Practice, and report relevant metrics to affiliate management team and other relevant internal stakeholders
- Develop and deliver regular Code of Practice -related training sessions to the affiliate
- Provide support for internal /external audits/inspections for the UK/Ireland Affiliate in relation to Code of Practice activities in collaboration with the Quality team
- As Business Partner to a therapy-aligned Business Unit, first-line point of contact for Code of Practice-related process question, escalating where required and working with the Quality and Compliance team, Final Signatories and Code of Practice Forum (as appropriate) to ensure timely responses/required solutions are delivered to internal stakeholders
Skills and Knowledge Requirements:
- Established knowledge of the quality management principles
- Experience and knowledge of the ABPI and IPHA Codes of Practice.
- Experience of Inspections/Internal audits/HCC checks
- Must be pro-active, self-motivated, highly flexible team player
- Excellent negotiation skills
- Excellent written and verbal communication skills
- Effective problem-solving skills
- Excellent time management and planning / organisational skills with the ability to work to strict timelines and handle multiple priorities / deadlines without losing attention to detail
- Appreciation of the reputation of the industry and an understanding of how to protect the company's reputation
- Life science/pharmacy degree Core Leadership Competencies (Behaviours) Demonstrate Adaptability
- Responds resourcefully to changing business demands and opportunities, proactively looking for ways to contribute
- Deals constructively with mistakes and setbacks
- Responds openly to feedback viewing suggestions as learning opportunities
- Accepts challenging assignments and new responsibilities Promote Open Communication
- Clearly articulates ideas, opinions, and information
- Listens to others viewpoints and asks questions to clarify for understanding.
- Promptly communicates information that others need to know in order to do their jobs.
- Is accessible and approachable to discuss issues, concerns and ideas Drive Innovation
- Continually works to improve products, services, and work processes
- Moves ideas forward into action Drive Execution
- Places a priority on getting results, balancing a bias for action with high quality outcomes
- Identifies and anticipates internal and/or external customer requirements and expectations
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Caleb Mensah on +44 203 854 1080 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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