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:
The role of the Director is to provide leadership to the Quality Operations Development Projects Team to support the development pipeline from a scientific, quality and patient-centered viewpoint. It also includes the management of development projects within the team. The position reports to the Senior Director, Quality External Manufacturing
Responsibilities:
The position is responsible for the management of the day-to-day Quality activities relating to development projects and providing technical support in relation to issues that can arise with development products, contract manufacturing organizations and material suppliers, to all applicable GXP standards. This role also includes cross-functional team membership/collaboration and support for quality aspects of CMC regulatory dossiers.
Responsible for, but not limited to:
Manage and direct the Quality Operations development projects team to ensure successful outcomes for development projects
Liaising with the relevant departments within the business and working closely with the Quality Development Team to ensure agreed milestones/targets are met.
Ensure and provide support to the Quality representatives on the CMC Product Team(s)
Ensuring compliance of all respective contract manufacturers to both internal requirements and country-specific regulations
Work closely with Clinical Trial Management Supply Team to ensure the supply of clinical trial material to clinical development programmes
Provision of advice on technical issues that may arise for both small and large molecules including highlighting/directing the appropriate risk management.
SME input to Product Quality Technical Agreements within the Quality Department as required
Inspection readiness support for developing products including the development of playbooks
Periodic QP support within Quality Operations in relation to both Commercial and clinical trial supply.
Facilitating technology transfer, process scale-up and process improvement projects
Management of external Quality consultants used to support development projects
Serve as a member of Quality Council and prepare material as required
Provide information to the Supplier Review Board in the context of development projects
Conducting vendor audits and vendor site visits as required
Assisting in internal audits and regulatory agency inspections
Provide SME technical support as required to the successful outcome of all regulatory inspections, both internally and at contract manufacturers, packagers and laboratories, as required.
Assisting with the transitioning of development products from the Investigational Medicinal Product space to Commercial Medicinal Product space
Participation in due diligence activities associated with strategic partnerships or new company acquisitions as required
Reviewing new critical regulations and guidelines, as they apply to product development from a quality perspective, and advising and assisting with implementation where appropriate
Other Responsibilities:
Communicate, where appropriate, with all corporate personnel and contribute to development projects 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 as they relate to developing products in order to ensure compliance
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 the 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.
This position will require up to 20% travel
Representation at external meetings from time to time
Person Spec:
Bachelor’s degree in chemistry, pharmacy or other related life science discipline
Significant experience (5-10 years) in drug development (Phase 1-IV) and cGMP including broad exposure to multiple dosage forms. or finished product pharmaceutical/biologics, including validation, analytical chemistry, quality assurance, quality control, development and /or manufacturing areas or knowledge/experience
Eligibility to act as a licensed Qualified Person
Thorough understanding of Quality Systems and cGMP’s.as they relate to product development
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
Personal Competencies:
Highly organised, with good time management and prioritization
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
Cv to Gerry Kennedy at The RFT Group gerry@rftgroup.ie 01 2302400 www.rftgroup.ie