Manage the QA Department to ensure all regulatory, cGMP and standards are consistently maintained
Senior QA Manager- Pharmaceuticals- Dublin
The primary purpose of the Senior Manager of Quality Assurance is to effectively manage the QA Department to ensure all regulatory, cGMP and corporate standards are consistently maintained throughout all activities associated with the manufacture and release of commercial and investigational medicinal products.
- Manage the manufacturing QA group including batch release analysts and QP group, ensuring manufacturing and batch release is completed in compliance with GMP and the requirements of marketing authorisation. Participate in unplanned deviation investigation and Laboratory Investigations as required.
- Manage the validation group - equipment, software and process revalidation, ensuring that all validation activities are executed in accordance with company, industry and regulatory standards.
- Support the Technical Affairs Department in New Product Development activities within the company ensuring successful progress to commercial manufacture.
- Fulfilling the role of the Qualified Person for commercial and investigational medicinal products (IMPs) within the company in accordance with EU Directives and relevant current guidelines.
- Assisting the company in preparing for compliance audits by customers/regulators, to include the satisfactory close out on any matters arising from same.
- Work with the Senior Director, Quality and other Departments to ensure the company meets its quality, customer service, safety and financial goals.
Education and Experience:
- An MSc in Pharmaceutical Science or similar course recognised by HPRA to permit Qualified Person status as per Article 49 of Directive 2001/83/EC
- At least 10 years' experience in the Pharma industry having served a minimum of 5 years at a Supervisory Level (or above) in a "Quality" centric capacity.
- Experience of working within a FDA and EMA regulated environment
- Previous experience of IMP release activities (preferable).
- Excellent People Management Skills
- Excellent Organisation, Report Writing, Communication, Problem Solving and Presentation Skills.
- Sound Decision Making and Negotiation capabilities.
Morgan McKinley is acting as an Employment Agency in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.