Elixir Associates is currently partnered with an Innovative Biotech that is developing the best-in-class therapies for Oncology and Autoimmune diseases.
About The Role:
The Head of Quality Control Operations will be responsible for leading all QC 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/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 & commercial activities, ensuring product quality and compliance with regulatory requirements.
Requirements:
- A scientific, engineering, or other related degree
- 10+ years of related experience with 7+ in a management role.
- Relevant experience in a production environment within a Laboratory and Quality Compliance roles within a Biotechnology/GMP environment,
- Experience and understanding of Vaccines, Oncolytic viruses or Cell & Gene Therapies.
- In-depth knowledge of industry standards and regulations related to quality control.
- Knowledge of FDA, EMA, CFDA, PDA Regulations, Good Data and Documentation Practices (GDDP), and application of current Good Manufacturing Practices (cGMP).