Quality Assurance Lead

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.