Auftragsdetails

Detailed Description

The Quality Manager serves as the central/regional point of control for Audit Management, Deviation and CAPA Management, Document Control, and develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements.

This is a leadership role where you will manage a team of 6 direct reports and drive positive change and process improvement. You will utilise your Quality expertise to represent the needs and perspectives of the Quality department and collaborate with various operational teams across the business to support the achievements of ProPharma's business goals.

The role will be offered on a remote basis with travel required for occasional onsite audits at our office located at Olliver, Aske, Richmond North Yorkshire, DL10 5HX.

Essential Functions:

Personnel Management

• Provides direction, guidance, support, and ongoing performance feedback to direct reports.
• Make decisions consistent with company guidelines and policies.
• Fosters an environment of teamwork and collaboration.
• Conducts annual performance and compensation reviews.
• Participate in staffing responsibilities such as hiring, schedules, performance/disciplinary, training, separations.

General

• Implement and maintain the Quality Management System and processes to ensure high quality services and compliance with applicable current Good Practices (cGXPs), including GMPs, GCPs and GVPs.
• Maintain awareness of, and ensuring compliance with, the legal requirements and professional guidelines associated with the provision of Medical Information (MI), Pharmacovigilance (PV) and Clinical Pharmacovigilance (CPV) on behalf of the pharmaceutical industry.
• Identify potential quality failures and establish appropriate corrective actions including coordination of their implementation
• Project and maintain professionalism in handling difficult situations and in times of stress.
• Flexibility to adapt and meet fluctuating business priorities

Qualified candidates must have:

• University/Bachelor’s degree and/or or appropriate relevant work experience
• 5 years of Quality operations experience required within the pharmaceutical, medical device or another regulated industry
• 2 years’ experience hosting, leading and/or attending audits as a Quality representative
• 1 year of people management experience
• Preferred: Working knowledge of quality audit practices in pharmaceutical and medical device relating to MI, PV, and CPV