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Director of Quality Assurance

2 months ago

London, Greater London, United Kingdom Elixir Associates Full time

Elixir Associates is currently partnered with an innovative biotechnology company that is developing best-in-class therapies for oncology and autoimmune diseases.

About the Role:

The Director of Quality Assurance will be responsible for leading all quality control functions across the EU and US.

Lead the implementation of global quality control policies and procedures within the UK & US, ensuring alignment with the company's commercial and clinical goals and regulatory requirements.

Be a player/coach mentor leading a high-performing team, continuously improving team efficiency through effective management methods, such as fair and objective performance evaluation of the team members and effective internal communication.

Ensure successful relationships across cross-functional departments and external partners engaged in the testing and release of raw materials, critical excipients, in-process, finished products, and stability samples.

Provide quality control support and oversight for clinical manufacturing and commercial activities, ensuring product quality and compliance with regulatory requirements.

Responsibilities:

  • Develop and implement quality control policies and procedures to ensure compliance with regulatory requirements.
  • Lead a team of quality control professionals to ensure efficient and effective quality control operations.
  • Collaborate with cross-functional departments to ensure successful relationships and effective communication.
  • Ensure quality control support and oversight for clinical manufacturing and commercial activities.
  • Develop and maintain relationships with external partners and vendors.