Senior Quality Assurance Manager

4 weeks ago

London, Greater London, United Kingdom Custom Pharma Services Full time

We are seeking a Senior Quality Assurance Manager to lead our QA and Analytical Service functions, collaborating across the business to establish, maintain and improve procedures and quality standards in accordance with UK, European and international GMP regulations.

Key Responsibilities:

  • Monitoring the quality performance of the business against agreed targets.
  • Leading regulatory authority audits and supporting regulatory submissions.
  • Ensuring a robust and phase appropriate Quality Management System (QMS) is in place to facilitate the development, manufacture, packaging, storage and distribution of product in a manner compliant with GMP, Customer and Regulatory Requirements.
  • Managing the activities of the company's QPs, QA and Analytical Services teams.
  • Liaising as required with clients and their quality and compliance executives to ensure there is a strong relationship of mutual support and customer service.
  • Ensuring the presence of adequate Customer Technical Agreements that foster and set up good communication with customer Quality Departments to ensure agreement and clarity on service level expectations and responsibilities over quality standards.
  • Managing, maintaining and improving the QMS to ensure it is current, meets and preferably exceeds statutory, industry and stakeholder expectations and embodies risk management principles throughout.
  • Managing and developing the quality team, ensuring their effectiveness and professional growth.
  • Representing the business with MHRA, international regulatory bodies and the UK Home Office.
  • Agreeing, managing and delivering financial performance to meet annual budgets for the Quality department.
  • Staff management and team building experience, including effectively managing and developing people.
  • Meeting Regulatory Compliance standards for the EU, US and other international markets.
  • Strategic planning and budgeting.
  • Implementing quality assurance systems in a GMP/GCP/GLP/GDP/IMP environment.

Our Benefits Package:

  • Rising holiday allowance to 26 days holiday plus UK bank holidays
  • Group personal pension scheme
  • Annual profit related company and individual bonus payment based on successful performance
  • Life assurance at twice annual salary
  • Health Plan with Simply Health including access to a GP or Counselling Services 24/7, money back on prescriptions, optical, dental and physiotherapy
  • Ride to work scheme
  • Subsidised Gym Membership
  • Discount Shopping Portal
  • Enhanced Maternity / Paternity Pay
  • Employee Referral Scheme bonus of £1,000
  • Free hot drinks vending

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