Senior Manager Quality Assurance


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2022-07-13 09:36:041970-01-01Team Horizon
Job TypePermanent
LocationMayo
AreaMayoMayoIrelandMayo
SectorQuality
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2549
Job Views49
Description
Senior Manager Quality Assurance – Team Horizon
 
Team Horizon currently has an exciting opening in Mayo for a Senior Manager to join the QA team for our client who are a global leader in the Biopharmaceutical Industry. In this role you will be 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 quality systems.
 
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary and benefits package.
  • Our client is forward thinking and pride themselves in excellence, both through their people and quality and dedication of customer care teams.
 
What you will bedoing:
  • Management and oversight of a large team or multiple teams across two functions, Quality Assurance (QA) and Quality Control (QC). Responsibilities include 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.
  • Establish training requirements and maintenance of a diverse and agile cross trained and effective QA team and laboratory personnel team to ensure business continuity and compliance.
  • 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 and QC to determine best steps forward.
  • Partnering with 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. Lead and oversee support activities related to product actions in the affiliate.
 

What you need to apply:
  • Master’s or Bachelor’s degree in Chemistry, Pharmacy, Biology or other technical/scientific area required.
  • 6-8 years’ experience in quality assurance, operations, regulatory, or relevant experience.
  • Minimum of 2 years’ supervisory/management experience.
  • Knowledge of aseptic manufacturing is essential.
  • 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 pharmaceutical products, combination products and devices.
  • Strong influencing, motivational, interpersonal, and relationship building skills at all levels.
  • Ability to make operational and business decisions with minimal direction.
  • Excellent written and oral communication skills.
  • Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded.
  • Strong computer skills and knowledge of enterprise systems such as SolTraqs, Attache, Attache Pro and various laboratory systems.
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