SENIOR QA Manager
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.
Tasks and responsibilities associated with the role of SENIOR MANAGER, QA.
- 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 authorization.
- Participate in unplanned deviation investigation and Laboratory Investigations as required.
- Manage the validation group equipment, software and process re-validation, 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.
The successful applicant must possess the following knowledge, skills, qualifications, attributes and experiences.
- An MSc in Pharmaceutical Science or similar course recognized by HPRA to permit Qualified Person status as per Article 49 of Directive 2001/83/EC
- At least 7-9 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.
- QP Qualified, Excellent People Management, Quality experience in a FDA & EMA regulated plant, IMP Release, Excellent Decision Making Skills, Communication Skills, Deviation investigations