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Senior Manager of Pharmaceutical Operations
2 months ago
We are seeking a highly experienced and ambitious leader to join our team as the Head of Pharmaceutical Quality and Regulatory Affairs at Rayner Surgical Group.
Key Responsibilities- Develop and implement strategic plans to ensure the success of our commercial plans and the availability of our ophthalmic medicines in the UK and US markets.
- Manage and maintain positive relationships with internal and external stakeholders, including contract manufacturers, logistics contractors, and regulatory bodies.
- Oversee the development and submission of pharmaceutical registration documents for UK, EU, and USA markets.
- Lead the Pharma QARA team in maintaining and delivering high-quality services and products.
- Continuously improve the Rayner Pharma Quality Management System (QMS) to ensure compliance with all applicable regulations.
- Run a program of internal and supplier audits to ensure compliance with regulations in target markets.
- Host external regulatory body audits of the Pharmaceutical QARA systems.
- Monitor and report on key performance indicators (KPIs) relevant to the department.
- Registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a Responsible Person for Wholesale Dealer's License (WDA) Holder.
- 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 registration documents for UK, EU, or USA.
- Experience in some area of ophthalmology.
- Experience as a Quality System leader in the pharmaceutical industry.
- Demonstrable knowledge of the regulatory environment relating to the manufacture of sterile products.
- Experience of sterile pharmaceutical products.
- Private healthcare.
- Wellbeing allowance up to £300.00 a year.
- Monthly yoga sessions and quarterly massages.
- Annual program of fun events.
- On-site restaurant.
- Enhanced maternity and paternity leave.
- On-site parking.
