Senior Quality Director
Posted on Sep 3, 2021 by Real Staffing Group
Biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs.
The company has a portfolio of medicines through its orphan, primary care and rheumatology business units. The company's global headquarters are in Dublin, Ireland. They also have office locations in US and Europe.
Reporting directly to the Vice President of Quality Operations, the Senior director leads the quality team responsible for the operational activities for all commercial biologic products.
They will lead the representation, communication and management of quality issues with internal partners, (including but not limited to business unit, technical operations, supply chain and R&D) and external partners (including but not limited to CMOs, 3rd party laboratories and alliance partners).
The successful candidate will manage the transition of - products from development to commercial, developing and executing quality operational, strategic and team goals for the biologics product portfolio in order to assure the highest quality standards, regulatory compliance and productivity.
- Ensure compliance of all respective contract manufacturers/suppliers to both internal company requirements and country specific regulations.
- Oversight of all product testing, methods, and investigations, including monitoring, tracking and reporting Quality KPIs.
- Evaluate proposed changes to the manufacturing and supply chain processes, including conducting regulatory impact assessments, and authorize these changes, if appropriate
- Build authentic relationships and leading business meetings and audits of critical suppliers and contract manufacturers and maintaining all product related Quality Technical Agreements (QTAs).
- Highlight any risks associated with maintaining supply of commercial drug products to all markets, offering innovative and effective ways to minimise such risks.
- Drive management of the supplier approval programme and execute supplier audits as per the external audit schedule.
- Participate in due diligence activities associated with strategic partnerships or new company acquisitions, supporting technology transfer, process scale-up and process improvement protects as needed.
- Support preparation of CMC (Quality) documentation for submissions and amendments/variations (egBLA submissions) inclusive of Module 2 (QOS) and Module 3 documents in accordance with Common Technical Document (CTD) guidance and company standards.
Qualifications and Skills Required
- A Master's degree in a science discipline is required, with an excellent understanding of quality assurance and CMC regulatory requirements.
- 10+ years pharmaceutical experience in Quality Control and/or Quality Assurance.
- In-depth knowledge of QA for drug substance and fill/finish manufacture is essential.
- Experience in an operational role at a biologics site is highly desirable.
For immediate consideration please apply with an up to date CV. Not sure yet? Would like more info? Please get in touch with me to discuss further.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales