- BBBH802338 Dec 21, 2021 Competitive
An amazing opportunity has arisen for a Quality Lead for a biologic's facility near Dublin.
This role will be at associate director level and will be responsible for providing QA direction for NPI at this state-of-the-art, single-use facility. This person will be responsible for managing and planning QA on site by supporting all divisions while ensuring compliance with cGMP and safety regulations. This is a key leadership position within the business and is on a permanent capacity.
The successful person will need to have 10-12 years' experience conducting similar duties coming from a Pharmaceutical and or biotechnology industry with 6-8 years at management level. A degree in a technical discipline such as chemistry, microbiology, or relevant education essential. Extensive knowledge in a GMP environment with experience leading QA teams through strategic planning and coaching. Proven experience in managing people and the ability to prioritise multiple aspects essential in this role. You will drive culture on site and communicate effectively across all disciplines.
- Oversee the sites overall function to meet and achieve site goals and objectives.
- Provide QA support to the qualification, validation, and technical transfers.
- Oversee QA function including systems, operations, disposition, quality risk management and inspection readiness.
- Hire, develop, mentor, and train the QA team to drive performance in line with site operations and development goals.
- Adhere to GMP regulations, cGMP, company policies, performance, and budget management.
- Management of site QMS including CAPAs, deviations, investigations, change control, complaints, documentation management etc.
- Support the sites lead auditor with inspection readiness and managing health authorities.
- Liaise with the internal quality groups to ensure on time disposition of commercial drug substance.
- Leads QA team in meeting targets and objectives to drive delivery.
- Create an environment of right first time to support and focus on the principle of lean.
- Management of batch reviews, reporting, investigations and CAPAs across the site.
- Guidance on quality related events to develop technical and compliance capability.
- Responsible for goal setting and performance reviews for direct reports and function.
- Ensure safety first quality always values are engrained in QA.
If this role is of interest, please 'apply now' or contact me on firstname.lastname@example.org or 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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