Quality Manager/Site GMP Auditor (Associate Director) - Ireland
Want to know company name or location? Company managed [?]
- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- The Quality Manager/GMP Site Auditor (Associate Director) will have the unique opportunity to work across Development, Clinical and Commercial activities for API and Drug Product businesses.
Key responsibilities will include:
- Lead scheduling and tracking of Quality System Audits and GMP Walk Downs in accordance with approved Audit plans for the site
- Lead site GMP audits in accordance with approved procedures and applicable standards and regulations
- Lead the development and implementation of CAPA following audit program completion
- Lead the compilation of quality metrics related to audits for dissemination at Quality Council and Management Review
- Recommend and lead implementation of improvements to the Audit and Inspection Management programs based on new regulations, guidance documents, and industry standards
- Lead in company and site preparations for support of regulatory and customer inspections
- Provide compliance advice to development and commercial product teams
- Supports and continually enhances the ongoing site Permanent Inspection Readiness status
- Lead training/orientation for new Quality Auditing staff
- Ensures that written procedures are followed, and exercises judgment in evaluating quality systems, processes, procedures, and protocols for compliance- Lead effective change management for Audit CAPA delivery
- Lead resolution of Supplier Quality issues to assure compliance and a flow of high Quality materials
- Reports to the site Quality Director and participates as part of the site Quality Leadership Team
- Minimum of 7 years Pharmaceutical industry experience within a GMP environment
- Extensive knowledge of US and European cGMP guidelines, ICH and other international regulatory requirements
- Extensive experience in GMP auditing across multiple Quality Management systems in API and/or Drug Product
- Experience in GMP auditing of Computerised System, Supplier Management and Logistics/Warehousing
- Experience working directly with regulators in audit situations
- Ability to build relationships and influence across disciplines and all levels
- Should be highly motivated, flexible, and have excellent organisational and communication skills
- Excellent verbal and written communication skills
- Ability to prioritize and balance work from multiple projects in parallel
Travel: Yes, 5 % of the Time
Job Segment: Audit, Law, Manager, Pharmaceutical, CAPA, Finance, Legal, Management, Science