Our client is an exciting, rapid growing biopharmaceutical business clearly focussed on establishing best in class teams across all its functions.
This Quality Director role is critical to the organisation and will have responsibility for the development of the company’s quality management system and supporting the clinical program associated with the development of a number of key assets. This permanent position will be based in Dublin, and will be responsible for all Quality operations including CMC & Device, Clinical and Corporate quality oversight.
The successful candidate will be part of a small and collaborative team which prides itself in producing high-quality work, while working in a fast-paced environment. In a young, flat organisation, this high profile role will provide you with the opportunity to make a real difference to patients lives, and to be part of its exciting journey while contributing to the ongoing success of the business.
- Work as part of a high paced, high achieving organisation in the development and delivery of paradigm shifting medications for neurological disorders.
- Develop and implement the quality strategy, covering the evolution of the company QMS from early clinical phase execution through the pivotal clinical program and into NDA submission and commercialisation, in alignment with company goals, development plans and Regulatory expectations.
- Responsible for setting the global Quality requirements and standards for each phase of the Device, Combination Product and Packaging Lifecycle.
- Develop and implement a robust and compliant QMS for clinical study execution, from Phase 1 to 3.
- Provide quality oversight, guidance and monitoring of internal functions and third-party vendors (CRO, CDMO, Consultants), setting appropriate Quality standards to be met.
- Ensuring appropriate and compliant documentation of all CMC activities is maintained, e.g., deviation investigations, CAPA reports, post implementation impact assessments, root cause analyses, risk assessment, change control.
- Review and approval (quality technical approval) of all analysis data, development reports and protocols, batch records, work orders, as required.
- Provide effective Quality leadership during internal and regulatory inspections and to take ownership of the Internal and External Auditing Program.
- University Degree (e.g., graduate biochemist, biologist, pharmacist, chemist, engineer), preferably with master’s level qualification.
- Minimum 5-7 years’ experience in a senior quality role in a pharmaceutical and/or biotech company preferably working with outsourced development. European Qualified Person eligibility / experience is a benefit.
- Current knowledge of ICH and ISO Guidance is an essential requirement
- Experience on quality documentation for inhalation combination products is beneficial but not essential
- Proven experience with working in a regulated environment under GxP with adherence to Company SOPs, policies and guidelines
- Substantial prior experience of forming effective relationships at all levels, must be able to work closely with technical, clinical and corporate functions to ensure alignment with program and company goals.
- Working knowledge and application of device and combination product regulations, including 21 CFR 820, 2017/745 MDR, ISO 13485, ISO 14971, and ICH Q9.
- In addition to being organized and analytical, you should possess the strong business judgment and communication skills needed to interact with, and influence teams/colleagues both internally and externally, at levels of the organisation.
- You will also need to be comfortable working in an early-stage research biotech business in pre-revenue/profits phase, be flexible, adaptable, energetic and enthusiastic, and prepared to be hands-on and willing and able to roll up the sleeves as required across the company.
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