Description
THE COMPANY
The Harvey Nash Group was founded in the UK in 1988, and now has offices throughout Europe, America and Asia. The Harvey Nash Group is known for the thousands of successful assignments completed throughout the world. From more than 39 offices, and with 5000 staff and associates, we offer a unique range of consulting recruitment specialising in IT & Engineering recruitment, benefits subcontracting and outsourcing services to our clients. Our departments of and support our customers around the world by placing the senior managers essential to business growth and effective management.For our client we're actively looking for a Quality & Risk Manager for Global Medical Affairs.
KEY RESPONSIBILITIES
1.Provide support for Global Medical Affairs (GMA) Risk Management
Support the business by driving and/or assisting the development/update of the Risk Universe (RU) , the Risk Register (RR) and associated Risk Treatment Plans (RTPs)
Help in tprocess of periodic review of the RU and RR by e.i. seeking input from the business, stakeholders
Ensure the easyDoc community on Risk Management activities is updated accordingly
Collaborate in issuing periodic progress reports or presentations on risk management activities (with figures) to the GMA management team or client's Quality Bodies as appropriate
Work/communicate with the other Compliance Units, other departments like GVCoE (Global Commercial group) impacting GMA or other QRMs as appropriate
2.Participate in audit/inspection management activities including GMA and GVCoE
Facilitate central process audit/inspection coordination in audit/inspection scoping, preparation, coordination and internal communication
Prepare/support the business for audits/inspections (preparation meetings, advise during audit or inspection and on audit/inspection report responses)
Interact with the different departments impacted by the audits/inspection within Biologicals, as well as with the corporate auditors
Collaborate in follow up and tracking of corrective and preventive action plans (CAPAs)
Participate in sharing or trending of audit/inspection findings
Liaise with the SOP and Training groups as appropriate
3.Lead or participate actively in specific projects across GMA (and GVCoE)
Direct or coordinate quality control activities defined with the GMA Operations team
Provide input in assessment of results
Establish (progress) reports on these activities to enable appropriate decision from the GMA management team
4.Help in the management of L1 and L2 activities (QC and audits/assessments)Participate in the creation of agreed QC forms, checklists or tabs to support L1 activities
Participate in the gap analysis of L2 activities controls for GMA significant risks in view of implementing an annual QA plan
5.Providing advice and guidance on applicable policies and procedures to GMA (and GVCoE where applicable) customers
Provide consultancy in line with specific projects that are running: day to day questions; advise to task forces, ad hoc representation for process documents (POL,SOP) review cycle needs, representation in task forces
Work with Training & SOP Team as appropriate
PREREQUISITES
Education Master degree in Sciences (Life Science subject) or equivalent by experience
Excellent knowledge of Medical Affairs activities
Excellent knowledge of written & spoken English
Strong Quality mindset
Good communication skills, both oral and written
Well organized, concern for order and clarity
Good analytical skills
Good sense of urgency
High level of personal integrity
Ability to handle sensitive and confidential issues with complete discretion
Able to promote friendly climate and co-operation, team spirit
Independent work
Stress resistant
Motivated and dynamic personality
Proactive
Familiar with electronic tools like Microsoft Word, Excel, PowerPoint
2-3 years' experience in medical affairs or clinical rarch or clinical safety/pharmacovigilance or regulatory affairs in the pharmaceutical industry or academic field
Should the aforementioned degree and type of experience not be available, a Quality Assurance background in other areas (eg GCP, GLP, GMP etc.) will be regarded as equivalent.