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Job Details

Quality Leader/Manager PDMA Switzerland

Company: Key People Limited
Location: Switzerland
Closing Date: 29 Oct 16
Type: Contract
Salary (£): Negotiable

Job Summary:

Our leading Pharmaceutical client is looking for a Quality Leader / Manager with experience within the Pharmaceutical and pref Medical Affairs arenas.To Provide Global Product Development Medical Affairs (PDMA) staff with Compliance support.Duties include Quality Management, SOP's, Compliance support, ICH / GCP.


Job Title : Quality Leader PDMA

Objectives and Scope of Position:
• To provide Global Product Development Medical Affairs (PDMA) staff with compliance support
to ensure that all medical affairs activities are conducted in accordance to the clients SOPs, guidelines and policies and all international (ICH, GCP) & Health Authority regulations
• To provide Quality Management support to PDMA and the Affiliates, and deliver a quality
oversight plan and metrics ensuring that Medical Affairs activities are executed efficiently,effectively and in compliance with regulations
• To support the sharing of ‘best practice’ learnings within PDMA and the Medical Network

Summary of Main Responsibilities:

Training & Induction Programs
• Ensure PDMA staff are trained on the clients Controlled Documents and international regulations
(ICH GCP) or Health Authorities requirements
• Co-ordinate the Learning Management system for PDMA and maintain PDMA Training Grid
for Controlled Documents for relevant functions and external vendors
• Support the functional induction and orientation program for new PDMA staff
Quality Management
• Implement Quality Management processes to improve the accuracy or timelines of its
output, or to meet established standards (e.g. compliance checks)
• Develop and maintain PDMA quality standards & metrics for key medical affairs activities
• Active review of audit reports, propose and monitor action plans (CAPAs) to improve
medical affairs standards & processes
• Member of Quality networks
• Inspection Readiness support for PDMA

Compliance support
• Provide compliance support by answering questions or providing advice on ICH GCP, SOPs,
regulations and guidelines and bring issues to the attention of PDMA Leadership Team
members as appropriate.
• Play an active role in the preparation and review of Controlled Documents &
processes/working guidelines
• Work proactively as a member of global and regional Compliance & Training networks to
maintain and improve consistency across the organization, and sharing of best practices
• In collaboration with other Global Functions develop and maintain metrics to ensure
Affiliates medical compliance
• Promote cross-functional and Affiliates communication
• Is responsible for acting in line with legal, regulatory and company standards and codes of
practice (e.g. The Clients Code of Conduct, applicable directives, guidelines and SOPs)
• Completes all required training modules as a priority
Professional and Technical Requirements:
• University degree preferably in life sciences /biology/medicine or other healthcare discipline

Apply for this job: Quality Leader/Manager PDMA Switzerland

Contact Information:

Address:  Head Office
Catherine House
Adelaide Street
St Albans
Tel:  Tel: 44 (0) 1727 811634
Fax:  Fax: 44 (0) 1727 844838
Website:  Visit Our Web Site

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