Quality Assurance Lead

Website Ref: TPM04462

Summary:
A Quality Assurance Lead is required for a biopharmaceutical company in Kildare. The successful candidate will support and manage all Quality Assurance Activities associated with a Business Unit for a defined suite of Products, also fulfilling an influencing role within the Quality Team. This is an exciting career opportunity to operate in a dynamic team environment, meeting business objectives through effective direction (coach, mentor and lead) – developing and supporting high performing teams in delivering solutions.

Responsibilities:

  • Contributes as a QA leader as part of a cross functional team, and as member of the QO leadership team.
  • Ensuring a constant state of compliance and audit readiness is maintained in line with current regulations, Quality Standards and business needs.
  • Decision making authority with respect to product quality, safety and efficacy in consultation with relevant stakeholders.
  • Quality oversight on Change Controls and Investigations (manufacturing, complaints, laboratory).
  • Management and oversight of Product Stability performance.
  • Annual Product Record Review approvals.
  • Quality oversight for Validation (process, equipment, computer systems).
  • Quality oversight for raw materials, packaging components, in-process product and supplier qualification.
  • QA support for the introduction of new, innovative products.
  • Providing QA technical direction and guidance to achieve overall business objectives.
  • Ensuring the QA function delivers efficient and effective business processes to support lean operations.
  • People reporting responsibilities, which includes selection and recruitment of colleagues. He/she will support a team of c. 4 -5 people.
  • Responsible for area budget preparation and management in conjunction with the Quality Operations Lead.

    Qualifications & Experience:

  • Third level Qualification Degree or higher in Science or a related discipline.
  • + 5 years’ relevant experience.
  • Experience in both QA and QC is desirable.
  • Eligibility for Qualified Person status (desirable).
  • Experience in a Pharmaceutical Management position.
  • Ability to interact in a corporate environment, with proven leadership qualities.
  • Ability to represent the company in external forums, e.g., in interaction with regulatory agencies.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.