Our client is at the forefront of T-Cell therapy and partnered with one of the world’s most respected companies to bring these cancer curing therapies to commercialization. To achieve this goal, we are searching for a dynamic Life Sciences Quality Executive to join the team and build the cGMP quality team. Also, the company is in the process of designing and commissioning a new cGMP facility so this is an ideal time for a Quality leader to join the team and build the right systems from day-one.
Reporting to the CEO, this is a key leadership providing leadership for the Quality Assurance and Quality Control departments responsible for a new line of cGMP stemcell products and will ensure the successful development, implementation and maintenance of all quality systems for this product line. This position will be responsible for designing, planning and overseeing quality operations the new cGMP manufacturing facilities which are currently at the design phase and ensuring compliance with company procedures as well as regulatory agency requirements.
Duties and Responsibilities
- Oversee and direct the Global cGMP Quality Organization including cGMP Quality Assurance Operations and cGMP Quality Control Departments to assure compliance with company and regulatory
- Collaborate with key stakeholders in Process Development; Project Management, Manufacturing, and research use only Quality Unit and Regulatory Affairs to ensure robust quality support and oversight are in place to further project
- Design, develop and implement the company’s cGMP quality strategy during the early phases of building out a new cGMP facility
- Develop and implement cGMP systems and procedures including SOPs, policies, forms, and tools such as excel spreadsheets or
- Provide leadership to ensure all cGMP required validation is performed for process, tests, equipment and facilities to meet industry or regulatory
- Establish key objectives and metrics for evaluation of the effectiveness of the cGMP quality unit departments and supporting functions and lead Quality Management
- Develop and manage strategic plans and budgets for global cGMP quality
- Advanced degree (Master’s or Ph.D.) in a relevant scientific field with experience in a technical or administrative field related to the industry or
- Experience manufacturing biologic pharmaceuticals. Experience manufacturing cell culture media and antibodies is
- Minimum of 15 years of related professional experience in Quality Control/ Quality Assurance for biologics with a strong technical foundation in a cGMP environment is required. Solid record of increased responsible positions in research and development
- Demonstrated ability to work in fast-paced, team-oriented and self-directed entrepreneurial environment.
- Demonstrated strategic planning with proven ability to communicate a vision and drive
- In-depth knowledge of cGMP’s, Health Canada and FDA and EU regulations and practical experience in auditing practices and
For more information please contact
Tim Swanson at email@example.com or +1-604-639-9566