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Head of Pharmaceutical Quality and Regulatory Affairs

2 months ago

Worthing, West Sussex, United Kingdom Rayner Surgical Group Full time
About the Role

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.

This is a strategic role that requires a deep understanding of the pharmaceutical industry, quality management systems, and regulatory requirements.

Key Responsibilities
  • Developing and Implementing Quality Strategies
    • Collaborate with top management to develop and implement quality strategies that align with the company's goals and objectives.
  • Leading the Quality Team
    • Manage and lead the Pharmaceutical Quality and Regulatory Affairs team, ensuring they have the necessary resources and support to perform their duties effectively.
  • Ensuring Regulatory Compliance
    • Ensure that all pharmaceutical products and processes comply with relevant regulations and standards, including those related to quality management systems, good manufacturing practices, and good laboratory practices.
  • Managing Audits and Inspections
    • Coordinate and manage internal and external audits, including those conducted by regulatory bodies, to ensure compliance with regulatory requirements.
  • Monitoring and Reporting
    • Monitor and report on key performance indicators (KPIs) related to quality and regulatory compliance, providing insights and recommendations for improvement.
  • Stakeholder Management
    • Build and maintain positive relationships with internal and external stakeholders, including contract manufacturers, logistics contractors, pre-wholesalers, test houses, and regulatory bodies.
Requirements
  • Qualifications and Experience
    • 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 the 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.
  • Skills and Competencies
    • Strong leadership and management skills.
    • Excellent communication and interpersonal skills.
    • Ability to work in a fast-paced environment and prioritize tasks effectively.
    • Strong analytical and problem-solving skills.
    • Ability to build and maintain positive relationships with stakeholders.
What We Offer
  • Competitive Salary and Benefits
    • A competitive salary and benefits package, including private healthcare, wellbeing allowance, and enhanced maternity and paternity leave.
  • Opportunities for Professional Development
    • Opportunities for professional development and growth within the company.
  • Collaborative and Supportive Team Environment
    • A collaborative and supportive team environment that encourages open communication and teamwork.