Senior Quality Assurance Lead

4 weeks ago

ireland Fastnet Full time

About the Company - A fantastic career opportunity has arisen for an experienced Senior Quality Lead within the Pharma/ Biopharma sector, to join an expanding Biopharmaceutical companies’ Irish operation. The successful candidate will have a high level of technical competence, be a highly effective leader who will align with our client’s culture and values and have a level of personal ambition to develop with the organisation as it scales. This is a unique opportunity for a Quality Leader who can demonstrate a complex mix of leadership, be able to drive tactical day to day operations to the highest standard, deliver on metrics and be able to work with peers and Senior Leadership to develop the strategic roadways to optimise Quality processes within the operation.

About the Role - Essential Functions:

  • Responsible for the batch record review (batch records, IPC and QC test results) and disposition of the product batches for final packaging.
  • Responsible for maintaining an appropriate level of QA oversight of manufacturing and testing sites in the supply chain. This includes review and adjudication of all associated records such as third-party deviations, change controls, CAPAs etc.
  • Responsible for maintaining and executing relevant Quality Technical Agreements.
  • Participate in the Global supplier management program through planning, executing, and closure of External audits.
  • Act as a primary QA technical contact point and provide quality/ technical support as required.
  • Participate in the corporate Quality Management System and Quality workflows-such as for example- active participation and review of change controls, deviations, training, SOPs, CAPA etc.
  • Responsible for maintaining a self-inspection schedule for the Irish organisation and aiding other sites/offices with their self-inspection and internal audit responsibilities.
  • Responsible for serving as the local training coordinator, maintaining quality/compliance related training records for all GMP related staff in the Irish organisation and participate in global GMP related- training.
  • Provide quality/ technical support for intermediate product and customers.
  • Collate relevant information and participate in the intermediate product’s Quality Management and Product Quality.

Qualifications - Experience and Qualifications:

  • Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
  • Minimum of 10 years relevant quality management and compliance experience in the pharmaceutical/biotech industry
  • At least three years’ experience at management or supervisory level
  • Strong competency in commercial GMP solid oral dosage form manufacturing and supply
  • Previous experience in a Quality Control/Testing environment preferred
  • Working understanding and knowledge of ICH method development and validation
  • Thorough and up to date knowledge of cGMPs/GDPs and global regulatory requirements (HPRA/FDA/EU)
  • Previous demonstrated experience of working on one’s own initiative in a remote working environment
  • Experience of using an electronic QMS
  • Comprehensive experience working with a virtual external manufacturing organization including managing CMOs, CDMOs, and multiple qualified vendors

Pay range and compensation package - Can be based remotely within the Republic of Ireland but travel (25%) will be required.

Equal Opportunity Statement - Include a statement on commitment to diversity and inclusivity.

Seniority level
  • Mid-Senior level
Employment type
  • Full-time
Job function
  • Quality Assurance
Industries
  • Pharmaceutical Manufacturing
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