QARA Manager - Worthing
My client is a leading developer and manufacturer of ophthalmic implants and pharmaceuticals; it specialises in intraocular lenses (IOLs) and related products used in cataract surgery and refractive surgery.
The company is looking for an experienced Quality and Regulatory Manager for its Pharmaceutical range of products. The role involves management of Regulatory Affairs of pharmaceutical products, Life Cycle Management of products, management of company QMS, adherence to responsibilities of Marketing Authorisation Holder, including management of pharmacovigilance compliance.
Your key responsibilities will be to
- Ensure all GDP activities are fully compliant and regulations and wholesale dealing licence is retained,
- Undertake the role of the Responsible Person (RP) as defined by the guidelines on GDP practice of medicinal products (2013/C242/01),
- To ensure that the operations team are fully supported in the wider business through organising resources and processes and the quality of medicines are medical devices are supplied,
- Ensure my client is fully compliant with all the relevant EU< FDA, and National Quality regulations, These include ECGMP Directive (2003/94/EC), the related EEC-GMP-Guide (EudraLex Volume IV) as well all appertaining EC guidelines and (ICH) as required,
- Lead due diligence for my client on new products opportunities in the areas of Medical, Regulatory, and Quality and to provide support to the Leadership team in other areas,
- Lead on non-clinical product development activities
- Manage medical affairs activities, including supervising our Pharmacovigilance consultant,
- Ensure regulatory filings and approvals are delivered to agreed timescales,
- Manage third party vendor relationships in the Regulatory, Medical Affairs, Quality and Pharmacovigilance areas, and
- The ability to participate in some multi-day travel to key suppliers and professional meeting (in the UK and overseas).
- Registered with MHRA as a Responsible Person for WDA(H),
- Life Science degree or equivalent professional qualification,
- Thorough understanding of the manufacture, testing and quality assurance of sterile products,
- Direct experience in a similar role, covering the creation, maintenance, and submission of pharmaceutical documents,
- Knowledge and experience of GDP, GMP and responsibilities of MAH,
- Knowledge and experience of pharmacovigilance systems, and
- Knowledge and experience of GMP and GDP audits.
- Experience as a Quality Systems Leader in the pharmaceutical industry,
- Demonstrable knowledge of the regulatory environment relating to the manufacture of sterile products,
- Experience of sterile pharmaceutical products, and
- Experience of ophthalmic products.
If you're interested in the QARA Manager position, please feel free to apply below and I will be in touch with a job spec and the benefits package.