Auftragsdetails

The Quality Manager provides leadership for quality activities and drives positive change and process improvement in the assigned region. This is a permanent role with ProPharma Group. This role functions as an independent and objective entity and operates in a multifaceted function by working and supporting various operational teams. The Quality Manager performs quality activities as outlined in ProPharma Group’s Quality Policy and procedures. Serves as the central/regional point of control for Audit Management, Deviation and CAPA Management, Document Control, and other Quality Management System activities. Develops, manages, and executes quality management processes to ensure quality standards are maintained and compliant with regulatory requirements.

Essential Functions Include:

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.

• Review workload on an ongoing basis to ensure effective resource allocation and utilization.

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.

• Support the monitoring and assessment for quality of the MI, PV and CPV services provided by ProPharma Group.

• Identify potential quality failures and establish appropriate corrective actions including coordination of their implementation.

• Oversee Standard Operating Procedure (SOP) and other controlled document development and maintenance process and participate in procedure development as appropriate.

• Serve as Subject Matter Expert (SME) for Operational Managers and Client Services in investigating and deviations, Quality Events, identifying CAPAs and communicating these to the internal and external stakeholders.

• Support internal audit activities, throughput coordination and management of CAPA responses, which requires close collaboration with management.

• Lead client audits and regulatory inspections processes by engaging with auditor/inspector in the coordination and finalization of agenda, document provision; ensuring internal logistics and SMEs are in place; Host and facilitate the audit/inspection; coordination and management of audit CAPA responses; and finally ensuring audit information is maintained and stored in eQMS.

• Coordinate client Questionnaire responses.

• Participate in relevant client operational meetings (i.e., standard meetings, Business Review and Ad Hoc meetings requiring QA representation).

• Liaising and communicating with all applicable internal and external stakeholders on all aspects of the Quality team’s responsibilities in a professional and business focused manner to ensure good relations between the Quality Department and the rest of ProPharma Group globally, and its clients.

• Perform other duties as required.

• Required: Bachelor’s degree or equivalent work experience in lieu of education.

• 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 required.

• Preferred: Working knowledge of quality audit practices in pharmaceutical and medical device relating to MI, PV, and CL. 

• Fluent in English speaking and writing.

• Knowledge and experience in working with Quality Management Systems (GxP, Pharmacovigilance).

• Proficient computer knowledge and computer keyboarding skills, including Microsoft Office Suite (Outlook, Word, Excel, PowerPoint). 

• Experience working with databases.

• Exceptional organization, prioritization, project management and delegation skills; able to multitask.

• Excellent verbal, written and interpersonal communication skills with the ability to establish strong professional relationships with clients, regulatory agency representatives and internal staff.

• Able to communicate quality issues to non-quality staff in a clear and concise manner.

• Excellent attention to detail and focus on quality.

• Exceptional customer service skills.

• Strong decision-making skills.

• Strong problem-solving skills.

• Able to project and maintain professionalism in handling difficult situations and in times of stress.

• Flexibility to adapt and meet fluctuating business priorities.

• Must be willing to travel at least 5%, including internationally.