External Site QA Lead – API (Assoc Dir)
A global innovator and leading biopharmaceutical company that has been inventing new groundbreaking treatments for numerous life-threatening diseases for more than a century. Through this organisation’s prescription medicines, vaccines, biologic therapies, and animal health products, they work with customers and operate in more than 140 countries to deliver innovative health solutions. As a result of continued expansion within the European Union and specifically the organisation’s decision to bolster the businesses QA oversight of external partners, a new position in the business has arisen for an External Site QA Lead – API (Associate Director) to be based at any of the organisations’ operations here in Ireland.
- Responsibility for oversight of Contract Manufacturing Operations API/intermediates for one or more External Parties (EP’s) with the assurance that the goods were produced in conformance to all applicable policies and procedures of the business and compliance with all governing regulations.
- Responsibility for Quality Control functions including oversight for product testing, as well as other relevant components as determined by applied calibrated Quality oversight.
- Assures the development and maintenance of a Quality Agreement with the EP.
- Provides input into the development of contractual agreements with the EP.
- Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP.
- Ensures permanent audit readiness, regulatory inspection support and monitoring, effective complaint management, change control oversight, metrics review, and review of annual product reviews. This also includes providing support to build effective quality systems at the partner and supporting continuous improvement activities.
- Serves as an EQA and Manufacturing Division subject matter expert in specific Quality systems, technology platforms, regulatory expectations and/or EP management. Utilises this expertise to drive improved and compliant processes/systems for EQA and Manufacturing Division.
- Provides support to the EP’s to facilitate and validate new product introductions.
- Conducts quality due diligence assessments for pre-approval considerations of new EP’s or introduction of new products.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc.)
- At least 5 years’ experience in the Pharmaceutical industry or a similar operating environment which includes experience in a management / leadership role in a Quality or Regulatory Affairs function.
To discover more about this opportunity, apply now or contact Shane Browne at HRM on +353 1 6321827 for a confidential discussion.
Salary: On Application
Location: Dublin City Centre