QA Compliance Manager – Inspection Management
My client are part of a global pharmaceutical company who have recently gone through and are continuing to go through major acquisitions. They create cutting-edge pharmaceutical products and have manufactured a range of global healthcare brands for several decades. As a result of their ongoing growth and expansion, they are seeking talented QA Compliance manager – Inspection – to add to their ever-growing innovative organisation.
As Senior Manager QA Compliance for Inspection your main activities will include the following:
- To provide expertise, guidance, and support to manufacturing sites by interpreting governmental regulations and guidelines, as well as internal and corporate policies to ensure compliance, efficiency, and effectiveness.
- To assist internal sites and/or external strategic business partners in avoiding objectionable findings arising from non-compliance
- Maintains expertise in current and emerging cGMP requirements and quality trends as they relate to Class III medical devices, combination products, biologics and solid dosage worldwide
- To scan external environment to assess GMP inspection trends and findings and assist Corporate and Site Quality Management to develop effective strategies to address and/or incorporate data from Regulatory Intelligence
- To ensure inspection readiness of the sites before the inspection to ensure the site logistics are adequate for the upcoming audits, setting up the facility and defining roles and responsibilities, preparing the sites proactively for handling of major deviations, complaints or other major product or systems issues
- To support the sites on Regulatory Agencies inspections
- To act as a liaison between the company and various governmental agencies and notified bodies to assure compliance to all quality and regulatory standards and notified body inspections
May involve travel up to 25% of the time within Europe and international.
The successful candidate will have the following:
- Bachelor’s Degree required. Chemistry or Life Science degree preferred. Some exceptions made for candidates demonstrating equivalent knowledge and having pharmaceutical experience.
- 10-12 years of Quality experience in a medical device, combination products and/or biologics environment including auditing and regulatory inspection experience.
- Eligible to live and work within the EU.
To Find out more Apply Online or call Gillian McMurrough at HRM on +353 1 6321827
Salary: €70000 - €83000
Location: Dublin North