Associate Director, GMP Quality Operations
Join an early-stage biotech company focused on the development of novel cell-based cancer therapies. The company has a team of biotechnology professionals with expertise in biologics discovery, characterization, and development. Lead products incorporate proprietary technologies that enhance tumor-specific killing by genetically engineered human immune cells. The company's vision is to bring ARC-SparX cell therapies to millions of patients who can self-administer prescribed SparX proteins to treat their cancer under the care of academic and community practices.
As Associate Director of GMP Quality Operations, you will be responsible for supporting the quality assurance and quality control programs. Reporting to the Sr. Director of GMP Quality Operations, the Associate Director of GMP Quality Operations will provide day-to-day quality support to various internal functions, and will be responsible for the administration of quality standards, internal practices, and continuous improvement as it relates to internal operations and collaborations with external vendors.
- Represent GMP Quality on project teams and act as a GMP Quality lead for the oversight of all quality aspects performed at manufacturing and testing partners.
- Support Management Quality Reviews and Product Reviews.
- Create, review and approve GMP-related documentation including (but not limited to) SOPs, batch records, specifications, master manufacturing records, analytical methods, labeling, protocols.
- Co-lead and coordinate investigations, including development and implementation of corrective actions.
- Support internal and external audits.
- Collaborate with cross functional team member to resolve quality issues.
- Develop and track key performance and quality metrics.
- Support validation activities related to facilities, equipment, processes, and computerized systems at contract sites.
- Partner with the Sr. Director of GMP Quality Operations in execution of department goals and metrics.
- Communicate and promote a culture of quality and operational excellence.
Requirements and Qualifications
- A Bachelor's degree in a scientific or technical discipline is required. An advanced degree is preferred.
- A minimum of 10 years of experience in a GxP biotechnology or pharmaceutical environment is required.
- Knowledge and experience in quality assurance and in a highly regulated manufacturing environment.
- Explicit experience working with Contract Manufacturing Organizations.
- Experience developing and implementing Inspection Readiness and PAI Plans.
- Extensive knowledge of US cGMP and GDP compliance regulations and industry practices, as well as EU GMP requirements.
- Ability to critically evaluate and troubleshoot complex problems and attention to detail.
- Ability to manage multiple priorities and aggressive timelines