An exciting opportunity has arisen for a Senior Compliance Manager to join a global biopharmaceutical company based in Cambridge, UK. A very patient-focused company, whose scientific research has resulted in 15 marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
- Reporting to the Director of Compliance, you will be responsible for leading the pharmacovigilance audit programme, including internal process audits and external vendor audits and you will coordinate audit follow-up and corrective action planning.
- Maintain knowledge of pharmacovigilance regulations and company standard operating procedures for pharmacovigilance.
- Ensure the completion of pharmacovigilance annual audit plans.
- Establish excellent working relationships with stakeholders in assigned departments and compliance/quality groups of vendors or business partners.
- Assist with activities for other GxP compliance programmes, and as such you will be required to develop knowledge in these areas.
- Responsible for providing guidance on interpretation and application of existing and new regulatory requirements to Regulatory Compliance management and assigned departments.
- Assist with the provision of guidance and training to Regulatory Compliance, developing standard training modules on special topics.
- Assist in the evaluation of SOPs and processes needed to comply with regulatory requirements.
- Provide guidance to assigned departments and management when specific compliance issues arise.
- Assist with the preparation, facilitation and follow-up of regulatory authority inspections.
- Foster a commitment to quality in individuals and a culture of quality within the organization.
- Establish relationships and agreements with consultant auditors.
- Both direct and collaborate with internal and external staff in the conduct of audits.
- Both lead and participate in intra- or interdepartmental teams of an operational nature such as: preparing the Company for changes in regulations, continuous improvement initiatives etc.
- Initiate operational change where required and communicate change in a positive manner.
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 Kevin Hansberry on +44 207 4400 636 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.