Senior QA Manager Dublin pharma
Our client is a fast growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research.
Responsible for performing key Quality tasks in respect of Company products. Work in the Quality Group within the Technical Operations Department, which oversee contract manufacturing operations, select supply chain operations and development functions as well as Internal Quality Systems. Reporting directly to the Director of Quality Operations
The position is responsible for monitoring and supporting the day-to-day Quality activities relating to the performance of contract manufacturing organisations and material suppliers to all applicable GXP standards. This position also involves membership of the External Manufacturing Product Teams Specifically, this position is responsible for developing commercial Quality oversight systems for existing products transitioning into the commercial portfolio and those transitioning from the Investigational Medicinal Product space to Commercial Medicinal Product space. This responsibility extends also to API manufacture.
Responsible for, but not limited to:
- Primary Quality representation on an External Manufacturing Product Team(s) and the provision of quality updates, guidance and decisions in relation to the teams product
- Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, validation protocols, change controls and leading product related investigations
- Ensuring compliance of all respective contract manufacturers to both internal requirements and country specific regulations
- Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues.
- Contributing as required to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.
- Highlighting any risks associated with maintaining supply of commercial drug products to the External Manufacturing Product Team(s) and Quality Leadership.
- Conducting vendor audits and vendor site visits as required
- Assisting in internal audits and regulatory agency inspections
- Processing out-of-specification (OOS) reports and provision to QC for review
- Reviewing product stability data and provision of data to QC for review and trending
- Ensuring personal metrics are met
- Reviewing and summarising CMO Annual Product Quality Reviews and supporting regulatory submissions
- Maintaining product related Quality Technical Agreements (QTAs)
- Understanding new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate
- Participation in due diligence activities associated with strategic partnerships or new company acquisitions as required
- Developing commercial Quality oversight systems for products transitioning from the Investigational Medicinal Product space to Commercial Medicinal Product space
- Transitioning existing commercialized medicinal products into the Commercial Medicinal Product organisation.
- Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.
- Communicate, where appropriate, with all corporate personnel and contribute to the development of global systems and procedures, as required.
- Contribute to the design and implementation of best practice quality improvement programmes and company expansion programmes.
- Contribute to the development of quality policies and procedures and participate in the internal audit programme, which serves to verify adherence to and compliance with the requirements set out in these controlled documents.
- Contribute, as required, to the development of new drugs, which will deliver a robust product pipeline without significant delays in the regulatory approval process.
- Work closely with other members of Technical Operations group to ensure delivery of key project objectives and timelines
- Foster a positive employee relations environment and a culture of continuous improvement and teamwork through the use of good and consistent management principles.
- Bachelor’s degree in chemistry, pharmacy or other related life science discipline
- Significant experience (5-10 years) working in finished product pharmaceutical / biologics, including validation, analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas
- Eligibility to act as a licensed Qualified Person
- Thorough understanding of Quality Systems and cGMP’s.
- Experience with third party vendor auditing, out of spec investigations, change control.
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
- Experience working with contract manufacturing
- Experience interfacing with regulatory bodies or working on regulatory submissions
- Highly organised, with exceptional time management and prioritisation
- Critical thinking and evaluation of process problems
- Excellent verbal and written communication skills
- Patient and results focused
- Good Leader and highly motivated.
- Collaborative team player
- Strong work ethic with a flexible and adaptable approach