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Covering the following locations: Cambridge, Guildford, Oxford, Reading

Job Title: Compliance Manager

Location: Head Office Based, Buckinghamshire

Reporting to: Medical Director

Objectives:
The Compliance Manager ensures that all Grünenthal Ltd SOPs, policies and procedures are adequate, effective, and conform with the UK pharmaceutical industry's practices and Government regulations.

1. Overall Purpose of the Role

Act as a central point of expertise for the Association of British Pharmaceutical Industry's (ABPI) Code of Practice for the Pharmaceutical industry ("ABPI Code")
Establish the company's local SOPs and policies related to ABPI Code
Ensure company Global and Local SOPs, policies, procedures, and standards of conduct are implemented within the remit of the ABPI Code by training and undertaking internal monitoring and audits to ensure the highest quality of compliance
Respond promptly to any detected deviations concerning the above, by developing corrective action plans which are promptly implemented
2. Limits of Authority/Freedom to Act

The holder of the position should:

Work closely with all the Directors to ensure that high standards are maintained with respect to the company's SOPs, policies and procedures
Ensure all feedback on relevant compliant matters is relayed to the Medical Director. This includes opportunities for improvement in efficiency and quality as well as reduction in the company's vulnerability to non-compliance
Ensure appropriate confidentiality is maintained regarding information relating to individuals and company plans.
3. Special Relationships and Contacts (Internal and External)

Reports to the Medical Director
Work will be mainly office based with occasional travel to attend relevant external meetings (including overseas to Grünenthal Headquarters at Aachen, Germany)
Internal
Source of expert ABPI Code advice and relevant company SOPs, policies and procedures
Consistently promotes best practice
Writes and reviews relevant company SOPs, policies and procedures
Works with Learning and Development and HR to ensure that all appropriate employees and contractual staff are knowledgeable of and compliant with the relevant company SOPs, policies and procedures by the provision of training and testing ( with certified materials) to:
New starters
Internal staff who move roles or promoted
All staff, as part of regular (e.g. annual) revision
Ensures a company training log is kept and that individuals keep personal training logs up to date with an accompany CV
Prepares a monthly report for the Board on the Compliance status within the company
Participates in monthly senior management meetings to:
present progress /updates
advise on planned and ongoing activities
Member of the SOP committee
Liaises with appropriate compliance staff in the UK Head office
Uses a set procedure to put in place corrective measures where identified and to liaises with HR staff where disciplinary matters need to be considered.
Liaises with Global (where UK non-staff residents are involved in company activities and events)
Special review of 2010 Bribery Act as related to company activities any other relevant change/addition in employment law
External
Maintains an awareness of any new or changes to any existing regulations that could have an impact on the UK business
Represents GRT UK on Code Compliance matters. May be called upon to interact with external bodies as appropriate e.g. the MHRA, PMCPA or Department of Health

Job Package

Competitive Basic Salary and benefits on offer

Person Profile

Special Requirements of the Role:

Technical:

Relevant university degree/qualification.
Pharmaceutical Industry experience
Detailed knowledge and practical implementation of all applicable rules and regulations relating to the pharmaceutical industry with particular reference to the ABPI Code and the MHRA Blue Guide
Previous experience of or familiarity with external audits by either the PMCPA or MHRA
Ability to appreciate the limits of their knowledge and to undertake research/seek further external advice as required, for complex compliance issues
Good document management skills
Appropriate Information Technology ("computer") skills and working knowledge/experience of standard software tools.
General:

Good communication skills with the ability to work with people at all levels in their organisation
Good organisational skills. Ability to meet deadlines, and have robust procedures in place to ensure that issues are dealt with promptly
Ability to work on multiple tasks simultaneously (includes ability to organise and prioritise).
Project management skills
Attention to detail
A high level of integrity
Fluent knowledge of English (spoken and written) and good report writing skills
Flexible, independent, and proactive working style
Self starter and able to work in a team

Interview Process

2 Stage Process

See more jobs from Grunenthal Ltd
Grunenthal Ltd
* Salary Guide
£50,000-£63,000
Buckinghamshire
Job Ref: 40565

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