Telephone: 086 8395533
R&D Quality Manager
Our client, a medical device company in Mayo are currently looking to recruit a R&D Quality Manager for their site.
This position is responsible for application of global Quality Assurance operational activities that balance patient safety, domestic and international regulatory requirements and Quality Assurance standards, with clinical supply needs, corporate and development milestones and commercial product launch timelines to biological CMC projects. The role interacts with all Global Teams to verify that Chemistry, Manufacturing, and Controls activities are in alignment with Clinical, Non-Clinical and Regulatory Affairs efforts in support of product development and launch. This position is also responsible for supporting operational activities and requirements for all new biological product candidates, ensuring critical patient safety parameters are met while minimizing time from discovery to clinic based on sound regulatory risk management and mitigation. As well as internal stakeholder interactions, this role will also interact with external stakeholders such as development partners, contract manufacturing or laboratory organizations and regulatory authorities
Essential Job Functions
- To provide a QA oversight and leadership for R&D Brand Biologics projects from early development phases through to regulatory submissions and PAI:
- To be QA representative on CMC teams
- To oversee all QA activities from cell banking through to final release to clinical trial sites
- Liaise with CMC project teams to ensure timely delivery of clinical trial supply materials
- Provide CMC teams with information and guidance on Quality related issues
- Prepare, manage and execute QA project plans
- Prepare, or oversee management of, Product Specification Files
- Review and approve Quality documentation relating to manufacture, testing and release of materials to be used in pre-clinical or clinical trials where appropriate, including those arising from validation and tech transfer activities
- Provide quality oversight for complex development supply chains encompassing internal and external suppliers of raw materials, drug substance and drug product manufacture and testing related to clinical trial supplies:
- Provide Quality input into supply chain activities such as approval of new suppliers, raw materials, components, subcontractors
- Liaise with third parties over QA related project matters, including preparation of QA agreements. Ensure third party QA related requests are reviewed and incorporated into appropriate documentation where required.
- Act as person-in-plant for manufacture/testing activities performed at subcontractors, where required.
- Participate in, and lead as required, investigations into project related OOS’s, deviations, complaints, as necessary.
- Communicate quality issues to releasing QP(s).
- Employs appropriate risk management strategies to minimize timelines without compromising patient safety:
- Identify quality risks associated with the project and assist in preparing mitigation plans.
- Participate in product and process risk assessments.
- Identify and escalate any quality related risks or concerns to CMC-lead and senior management.
- Ensure that all data relating to a batch intended for release (including data for raw materials, equipment/consumables preparation, manufacturing records, QC records, non-conformances/deviations) are collated, reviewed by the Production, QC and QA management and provided to the QP responsible for release of the manufactured material.
- Works with other area of PDQA to harmonize diverse development group efforts such as biologics/device.
- Mentor and support other CMC project leads
- Build relationships with key stakeholders e.g. R&D, Operations, Reg Affairs
- Apply the quality systems in conformance with Biologics Quality Policies to ensure compliance with cGMP in line with all licensed activities.
- Assess own workload and training and discuss with the Director, R&D Quality any perceived discrepancy between work assigned and ability to complete it.
- Participate in the change control procedure to ensure that all changes affecting the GMP areas in-house or at a third party are controlled to maintain compliance at all times.
- Participate in the evaluation of trends in non-conformances, environmental monitoring data, critical equipment performance and alert the Director, R&D Quality to any need for re assessment of quality standards.
- Communicate to the Director, R&D Quality in an effective manner the compliance status and significant issues.
- Participate in audit plans and resource requirements and internal and vendor audit programmes. Prepare audit reports and progress and corrective actions with auditees. Report progress and problems to the Director, R&D Quality.
- Support operational activities to ensure that materials and documentation of an appropriate standard are available and that manufacturing areas and equipment are released for use in a timely manner.
- Support QC activities to ensure that samples and documentation are supplied for testing, reporting and review for incorporation into batch documentation and release procedures.
- Provide support and guidance to ensure that all validation protocols meet requirements, current standards and industry practices. Ensure that all data relating to a validation exercise (including data for equipment/instrument calibration, planned preventative maintenance, exceptions, testing results) are collated correctly and reviewed by the system user / validation. Ensure validation reports reflect the true finding of the validation exercise and that significant issues are communicated to the Director, R&D Quality in an effective manner.
- Relevant experience within a Pharmaceutical R&D or commercial environment with a bachelor's degree or equivalent in Biology, Chemistry or Health Related Science.
- Experience in pharmaceutical Quality related role in a relevant pharmaceutical manufacturing environment.
- Experience in quality systems, quality methods, statistics, product qualification/validation, and a basic understanding of clinical product supply requirement
- Eligibility to act as a QP / trainee QP would be an advantage.
- Evidence of a high level of proficiency with IT Systems.
Skills, Knowledge and Personal Attributes
- Attention to detail
- Appreciation of need to comply with regulatory requirements
- Good organisational skills
- Excellent communication and interpersonal skills, with the ability to provide support to other teams in meeting the commitment to cGMP and patient safety.
- Keenness and ability to assimilate information for new Investigational Medicinal Products and apply relevant product quality specifications and in process controls.
- Some flexibility in working hours.
- Good knowledge of IT systems.
- Ability to work to written systems, and a methodical approach to performing duties.
- Helpful attitude, highly motivated team worker.
- Required: demonstrable ability to follow written procedures and to evaluate systems and records.
- Preferred: experience in Pharmaceutical Quality systems.
- Strong technical expertise in pharmaceutical validation
- Ability to travel both nationally and internationally up to 20% of working time
For further information on this R&D Quality Manager role in Mayo please contact Bimi on 086 8395533 / email@example.com
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