Senior Quality Audits Manager (Raleigh, North Carolina)

Company Description

We are PrimeVigilance (part of Ergomed Group), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs and Quality Assurance. 

PrimeVigilance provides first class support to our small to large pharmaceutical and biotechnology partners maintaining long lasting relationships and has become one of the global leaders in its field. We cover all therapy areas including medical device. 

We love investing in our staff by providing an excellent training and development platform. We value employee experience, well-being and mental health and we acknowledge that a healthy work life balance is a critical factor for employee satisfaction and in turn nurtures an environment from which a high-quality client service can be achieved. 

Come and join us in this exciting journey to make a positive impact in patient’s lives.

Job Description

The Senior Quality Audits Manager supports the 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 Senior Quality Audits Manager plays an active role in the preparation, maintenance, and execution of the internal Tactical Audit Program and will lead and/or co-audit, both internally and as a billable activity on behalf of clients as requested and in agreement with the Director, Quality Assurance, or the Vice President of Quality. The Senior Quality Audits 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 the internal Quality Risk Assessment methodology.
• Develops and maintains a comprehensive Audit Universe.
• 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.
• Conducts 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 Director, Quality Assurance and/or VP of Quality.
• Undertakes activities in relation to audits as a service, such as conducting audits under supervision, working with clients on a project level, project management with clients and provides PV QA expertise and knowledge.
• Conducts audit documentation peer review and quality control activities.
• Monitors compliance within the organisation to ensure early identification and resolution of quality issues.
• Documents audit findings and recommendations and identifies process improvement initiatives via trending data as provided by Quality Management.
• 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 Director, Quality Assurance and/or VP of Quality
• Mentors, trains, and develops new and more junior PV QA team members.
• Line management tasks (periodic appraisals, performing holiday approval, ensuring adequate cover is in place to meet operational requirements for existing and new contracts)

Qualifications

• A university degree in a healthcare discipline or equivalent scientific area
• 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
• Knowledge of international regulations related to Pharmacovigilance and Medical Information

Additional Information

We prioritize diversity, equity, and inclusion by creating an equal opportunities workplace and a human-centric environment where people of all cultural backgrounds, genders and ages can contribute and grow.

To succeed we must work together with a human first approach. Why? because our people are our greatest strength leading to our continued success on improving the lives of those around us. 

 We offer: 

• Training and career development opportunities internally
• Strong emphasis on personal and professional growth 
• Friendly, supportive working environment 
• Opportunity to work with colleagues based all over the world, with English as the company language 

Our core values are key to how we operate, and if you feel they resonate with you then Ergomed is a great company to join!

• Quality 
• Integrity & Trust
• Drive & Passion
• Agility & Responsiveness
• Belonging 
• Collaborative Partnerships

We look forward to welcoming your application!