Quality Assurance and Compliance Manager

Quality Assurance and Compliance Manager

PrimeVigilance

Prague or Remote, Czech Republic

Job Description

The Quality Assurance and Compliance Manager supports the (Associate) Director, Quality Assurance by leading all aspects of the design, implementation and management of internal and vendor audits and corresponding Quality Risk Management activities. The position is key in fostering a culture of quality within the PrimeVigilance organisation and acts as an ambassador for the PV QA department. Additionally, the Quality Assurance and Compliance Manager plays an active role in the preparation, maintenance, and execution of the internal Tactical Audit Program and will lead and/or co-audit, internally. The Quality Assurance and Compliance Manager plays a lead role in representing PV QA in their interaction and exposure to our clients within PV Operations.

Role and Responsibilities

• Develops and maintains a comprehensive Audit Universe.
• Develops and maintains the internal Quality Risk Assessment methodology.
• Leads Quality Assurance activities in relation to procurement and vendor oversight.
• Develops, maintains, and manages mechanisms that assure ongoing monitoring and compliance with all applicable laws and regulations including but not limited to EU GVP, USFDA CFRs, JMPA and ICH-E6.
• Coordinates and contributes to internal system and/or vendor audits initiated by PrimeVigilance, according to the approved Tactical Audit Plan and Annual Audit Plan, including effective management of pre-audit and post-audit activities.
• Supports the Audit CAPA team in the effective management of CAPAs arising from vendor audits.
• Hosts and supports audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities as agreed with (Associate) Director, Quality Assurance and/or VP of Quality.
• Conducts or coordinates audit documentation peer review and quality control activities.
• Monitors compliance within the organisation to ensure early identification and resolution of quality issues.
• Assesses audit findings and recommendations, and identifies process improvement initiatives via trending data as provided by other Quality teams (e.g Quality Management, CAPA Quality Assurance team).
• Fosters a culture of quality within the organisation as led by members of the Quality Leadership Team.
• Conducts other ad-hoc activities as requested by (Associate) Director, Quality Assurance and/or VP of Quality.

Qualifications

• University degree in biomedical sciences, natural sciences or health sciences, or a Bachelor’s or Master’s degree in a scientific discipline or an equivalent advanced degree with experience, or equivalent industry experience.
• Previous experience in a regulated industry in a quality setting, preferably in pharmaceuticals or healthcare.
• Thorough understanding of the principles of Quality Assurance.
• Experience of participating in audits and inspections.
• Excellent communication and facilitation skills within a global organization.
• Proactive and self-motivated.