Area R&D Quality Assurance Manager, Eastern Europe, Middle East & Africa

Area R&D Quality Assurance Manager, Eastern Europe, Middle East & Africa

AbbVie

Wroclaw, Poland

Job Description:

RDQA AREA has been implemented with the focus of building quality into R&D functions within a designated hub of Affiliates supporting AbbVie clinical trials. The new role of RDQA AREA Manager has been developed and will report to the RDQA AREA Head. Initial scope includes R&D, clinical development activities associated with investigational medicinal product (IMPs) clinical trials conducted globally for market authorization. Expected results are first pass approvals thereby ensuring access to innovative therapies by patients and advancing the pipeline.

Key Responsibilities Include:

  • Responsible for the integration and support of quality regulations: drug, biologics, device and/or combination products driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality systems.
  • Responsible for the management and oversight of a team, as applicable, including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues. Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs. In the case of some affiliates, the role may not include direct reports but is responsible for all Commercial QA activities at the commercial entity.
  • Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
  • Lead and oversee support activities related to product actions in the affiliate.
  • Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity.
  • Partner with stakeholders across the enterprise to gain a better understanding of processes external to QA to determine best steps forward.
  • Responsible for partnering and overseeing support activities related to product actions in the affiliate. Oversee coordination and investigation of key quality systems (ie. CAPA, product complaints) ensuring KPIs are being met.
  • Perform assessments to determine compliance to processes, procedures and regulations to identify potential gaps and mitigate and implement improvements. Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
  • Quality management of supplier qualification program including performance monitoring for key suppliers, QTA management and assessments.
  • Provide guidance and oversight for all activities governed by Good Storage and Distribution Practices including monitoring of controlled temperature and cold chain shipments. Represent affiliate QA in regional, global and cross functional teams, projects and programs, as appropriate.

Qualifications:

  • Bachelor’s Degree in Chemistry, Pharmacy, Biology, other technical/scientific area.
  • 2-4 years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred.
  • Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations.
  • Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting device, biologics and pharmaceutical products.
  • Strong influencing, motivational, interpersonal and relationship building skills at all levels.
  • Excellent written and oral communication skills. Proficiency in English.
  • Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
  • Strong decision making skills.
  • Negotiation skills, effective collaboration and ability to anticipate needs and requirements.
  • Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache and Attache Pro.

Travel:

25% Travel

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© EuroJobsites 2018

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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