Job Description
Our client is a fast-growing highly profitable multinational biopharmaceutical company with an exciting pipeline of drug compounds at an advanced stage in research.
Job Spec:
Responsible for performing key Quality tasks in respect of the Company commercial products and specific projects from time to time. Work in the Quality function, within the Technical Operations Department, which oversees contract manufacturing operations, select supply chain operations and QP activities as well as providing support to internal Quality Systems. Reports directly to the Executive Director of External Manufacturing Quality with responsibility for leading a team of direct reports.
Responsibilities:
This position is responsible for monitoring and supporting the quality performance of contract manufacturers, and material suppliers to all applicable standards for GMP and for QP activities in relation to commercial products. Also responsible for leading a team within Quality Commercial Product Operations.
Responsible but not limited to:
Managing product quality-related priorities and tasks at the respective contract manufacturers
Leading and monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, change controls and leading product related investigations
Provide weekly or bi-weekly CMO / Product status update to Senior Director External Manufacturing
Lead and manage a QA team, including setting goals, performance review, training, development and budgeting
Ensure timely disposition of commercial products and related QP activities within the team
Oversee Product Quality Review and annual report completion on time and suggest new ways to improve this process
Facilitating technology transfer, process scale-up and process improvement projects
Building authentic relationships and leading business meetings and audits where appropriate of critical suppliers and contract manufacturers and maintaining all product-related Quality Technical Agreements (QTAs)
Assisting in internal audits and regulatory agency inspections
Ensure compliance of all respective contract manufacturers to both internal requirements and country-specific regulations
Highlight any risks associated with maintaining the supply of commercial drug products to all markets and offer innovative and effective ways to minimize such risks,
Collaborate with all contract manufacturers, packagers and testing laboratories to resolve any quality issues and guarantee an uninterrupted supply of drug product to the markets.
Participate in due diligence activities associated with strategic partnerships or new company acquisitions
Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, packagers and laboratories, as required.
Maintain quality and regulatory compliance, to ensure that there are no significant regulatory agency citations associated with any company-specific GMP activities. In this respect, it may be necessary to collaborate with the regulatory affairs department and liaise with regulatory agencies in the process of resolving GMP specific quality issues.
Evaluate proposed changes to the manufacturing and supply chain processes, and authorize these changes, if appropriate.
Contribute to the management of the supplier approval programme against an agreed schedule
Understand new regulations and guidelines, as they apply to the company business, and implement systems and procedures to incorporate these new regulations, if appropriate.
Other Responsibilities:
Communicate, where appropriate, with the Corporate Compliance group, on areas of common interest.
Communicate as required to Commercial Product Governance Team on activities that relate to external manufacturing activities
Attend as required internal committees such as Quality Council
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.
Provide quality representation to the Commercial Products Product team and advise as appropriate
Person Spec
A Masters or PhD level in a science discipline is required, with an excellent understanding of quality assurance.
Qualified person status and experience is required.
At least 10 years’ experience gained in finished product pharmaceutical manufacturing with knowledge of biotechnology products and drug substance manufacture is desirable.
An excellent understanding of quality guidelines and regulatory requirements as they apply to the industry.
Proven track record in people management and personnel development.
Customer-orientated with excellent communication skills with an ability to apply pragmatic logic to problem-solving and issue resolution
Personal Competencies:
Authentic leadership aligned with the core company values to enable the pursuit of excellence.
Collaborative Team Player with good interpersonal skills
Patient and Results Focused
Strong Communication Skills
Integrity in words and actions
Ability to Adjust to and Manage Change
Show Resilience, be Flexible and Adaptable
Facilitate Creative and Innovative solutions
Cv to Gerry Kennedy at The RFT Group / gerry@rftgroup.ie /01 2302400/ www.rftgroup.ie