Job URL
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Job Details
Job ID: 108
Job Title: Quality Systems Manager
Job Type:
Hire Type: Direct Hire
Level: Managerial
Recruiters: Hannah Woodward
City: Harefield
Country England

Job Description
Description: Understand and have oversight of all Quality systems within Norgine. Utilising matrix management design, develop and maintain a Quality Management system (QMS) that is ‘fit for purpose’ and adapts to changing business needs.
Requirements/Qualifications: SKILLS & KNOWLEDGE

Experience at a managerial level in a medium to large sized organisation and a thorough knowledge of GxP/FDA guidelines for the manufacture of pharmaceutical products and ISO standards for Medical Devices.

• Clear understanding of the pharmaceutical and medical device industry
• Strong analytical skills with respect to organisational patterns, to professional and personal interactions between staff and to documented evidence.
• Experience of working within Quality Management Systems within a pharmaceutical company
• Experience of setting up and managing Quality Management Systems
• A scientific degree.
• Wide range of GxP auditing experience
• Ability to present effectively to groups.
• Ability to build effective relationships (internal and external) strong influencing skills
• Excellent verbal and written communication skills, including the ability to interact effectively with different audiences.
• Excellent networker with the ability to collaborate and agree outcomes.
Responsibilities: MAIN PURPOSE:

Understand and have oversight of all Quality systems within Norgine. Utilising matrix management design, develop and maintain a Quality Management system (QMS) that is ‘fit for purpose’ and adapts to changing business needs.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Management
• Design, develop and maintain the Quality Management System (QMS)
• Provide oversight of current and evolving regulatory requirements to ensure the QMS remains current.
• Ensure those processes needed for the quality management system are established, implemented and maintained
• Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to GxP, medical device and code of practice requirements.
• Act as a leader of global quality and to ensure that their actions and behaviours reflect the norm of the department at all times.
• Report to senior management on the performance of the quality management system and any need for improvement using KPIs
• Maintain awareness of customer requirements throughout the organization and ensure these are supported by the QMS.

Quality system

• Implement and maintain the electronic tool (trackwise) used to manage records within the QMS
• Implement and maintenan the global QE/CAPA and eGSOP processes
• Ensure that the QMS supports the needs and local implementations of ICH Q10
• Development of globally harmonised processes for critical business processes
• Development and maintenance of the QMS that meets Regulatory and business expectations for Medicinal Products and Medical Devices.

Accountabilities
• D design, development and continuous review of the QMS to ensure its continues to meet business and regulatory expectations for Medicinal Products and Medical Devices.
• Performs and executes audits in compliance with GxP, code of practice and ISO 13485 as applicable.
• Accountable for GSOP, and eQMS systems

MAIN TASKS

• Design, continuously develop and maintain the Quality Management System (QMS) so that processes are in place and supported to ensure compliance with regulatory requirements impacting the whole of Norgine.
• Report to senior management on the performance of the quality management system and any need for improvement, and ensuring the promotion of awareness of customer requirements throughout the organization.
• Support the implementation of compliance improvements across the Norgine business.
• Implement and maintain the electronic QMS (trackwise) used to manage Quality records

RELATIONSHIPS:

Interact with and make reports to VP and director level across the organisation.
Influence management in a constructive way to support the Quality System Strategy
Norgine BV management are the key stakeholder related to medical device requirements
The individual must ensure excellent teamwork within and across Norgine, both within quality and across all functions and business units.
Ability to work and lead successfully in a matrix organisation.
Ability to influence and challenge others in a constructive way.

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