Quality Manager, QEs and CAPAs

2 tygodni temu

Kraków, Lesser Poland PrimeVigilance Pełny etat

We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider initially 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 becoming one of the global leaders in its fields. We cover all therapy areas including medical devices.

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 Quality Manager, QEs and CAPAs, is responsible for leading PrimeVigilance's Quality Event and CAPA team in line with global strategic objectives and assists in pragmatically developing a culture of Quality Excellence. The role holder will ensure that reporting, review and analysis of Quality Events and CAPAs is performed efficiently and in compliance with global regulations, legislation and PrimeVigilance requirements. The Quality Manager QEs and CAPAs, leads, educates, mentors, and develops the team within the function to ensure their competence and confidence in developing to become subject matter experts.

Lead the QE and CAPA team to ensure that PrimeVigilance's activities are in compliance with applicable regulatory requirements, and that its clients' Sponsor and Marketing Authorisation Holder obligations are fulfilled. Ensures support and advice to PrimeVigilance functional teams is provided in identifying, reporting and addressing deviations, non-conformities and issues.

Activities include, but are not limited to:

  • Review and approve the need for a CAPA plan
  • Ensures support and advice to PrimeVigilance functional teams is provided in creating, managing and implementing CAPA plans
  • Identify and escalate serious and/or systemic issues to (Associate) Director of Quality Management.
  • Performs periodic trending of deviations data across the company, providing insights into the potential causes of trends to operational and quality management.
  • Performs training on CAPA management process (both to new QE and CAPA team members and to functional department team members)
  • Ensure that relevant QE and CAPA reports are generated within timelines
  • Distributes information related to QEs is visible to internal customers through the use of dashboards.
Qualifications
  • Strong experience with QA, QEs and CAPAs as well as Pharmacovigilance experience
  • Ideally CRO background
  • Previous Line Management experience is mandatory
  • Must be organised with prioritisation skills
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 PrimeVigilance could be a great company to join

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

We look forward to welcoming your application.

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