The Quality Site Head is responsible for Quality Control, Quality Assurance, Quality Systems and QA Validation on the Shanbally site that performs Drug Substance Manufacturing, Secondary Packaging Operations, Drug Product QC Release testing and QP release of product to market.
Accountable for the product quality, regulatory compliance, quality systems and related processes for the site.
Accountable for providing leadership to the site in establishing compliance with marketing authorizations of drug substances and secondary packaged product with established specifications, compliance with regulations and other applicable standards.
Partner with Site Operations to drive quality and compliance excellence through supplying quality products from the site which are compliant with regulatory requirements and meet customer needs.
Lead the Quality function team to perform batch review, testing and release activities to certify product in compliance with specifications and procedures, ensuring timely resolution of quality system issues and timely disposition of product.
Mange the team to ensure valid processes, equipment and associated computerized systems.
Lead and engage the site quality review team (SQRT) process to ensure site regulatory compliance to identify opportunities for continual improvement of products, processes and the quality system itself.
Ensure site inspection readiness and host Health Authority inspections.
Build talent and foster colleague development, growing the leadership and capabilities within Quality across the site organization.
Develop and maintain an organizational structure consistent with the area needs and goals, including the preparation and administration of annual performance assessments and discussions.
Contribute to the overall leadership and management of the Shanbally site. And actively contribute to the Global TOPS & Quality Organization.
The scope of this role also includes quality budget and resource planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives, and quality specific projects.
Advanced degree in pharmaceutical science, biology, chemistry, engineering or related science.
At least 15 years work experience in the pharmaceutical Industry preferably within different functions within Operations and/or Quality & Compliance, with 10 years of supervisory experience, preferably at multiple sites.
Exposure to Regulatory inspections.
Evaluating and continuously improving site Quality Systems.
Demonstrated knowledge and applicability of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems.
Has demonstrated leadership management, coaching, development and technical capabilities.
Strong verbal, written, presentation and interpersonal communication skills.
Proven ability to plan, implement, and achieve significant, complex goals and objectives.
Desirable to have exposure to Lean, Six Sigma and Transformation.
HPRA QP certification or the technical competencies to be certified as QP by HPRA is desirable.
Minimum of 10 years related pharmaceutical experience and 5 years quality operations experience with minimum of B.S. in a Science related fields such as degree in Chemistry, Microbiology, Pharmacy or Chemical Engineering. Demonstrated capability of managing managers and teams. QP qualification would be an advantage.