About this job
Bellicum Pharmaceuticals, located in Houston, Texas, with offices in San Francisco and Zug, Switzerland, is a clinical stage pharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including both hematological and solid tumors, as well as orphan inherited blood disorders. With the first CAR T products being approved, cell therapy is coming of age. Bellicum is well-positioned to help build on these early successes, and deliver novel treatments that can change the lives of patients and their families.
As we grow new opportunities are always opening up. At the moment, we are seeking a Clinical Quality Assurance Auditor. Based in the Houston Medical center and reporting to the Director of Quality Assurance, this role is responsible for overseeing the planning, development, implementation, coordination and continuous improvement of processes and methods used to control the quality of studies conducted within Bellicum Pharmaceuticals.
Specific Job Duties
- Ensure clinical trials are performed with adherence to regulatory agency guidelines and industry best practices.
- Collaborate with clinical operations, regulatory affairs, technical operations and quality assurance to ensure compliance to requirements, continuous improvement resulting in the progression of clinical trials.
- Define, develop, implement and maintain ICH/GCP compliant processes which control the quality of work for clinical trials.
- Actively lead or assist in the areas of internal and external quality audits, trial support, technical operations support, quality management reviews, discrepancy resolutions and CAPA’s.
- Oversee and participate in auditing activities that ensure compliance with sponsor protocols, GCP/ICH requirements, industry guidelines, regulatory agency requirements and industry best practices.
- Identify non-conformance with requirements and provide a suitable path forward for resolution within an acceptable timeframe based on risk based assessment.
- Oversee contracted auditors for the clinical programs.
- Provide GCP and other relevant regulatory training to clinical and regulatory personnel.
- Review and assess sponsor and vendor supplied documents and records for conformance to regulatory requirements and best documentation practices.
Skills, Minimum Education, and Experience
- Undergraduate degree in a scientific discipline relevant to the work being performed at Bellicum (Microbiology, Immunology, molecular biology) – Graduate degree preferred
- Minimum of three years’ biotechnology/pharmaceutical industry experience in clinical quality with strong auditing history, in the US and EU.
- Proven knowledge and experience with regulatory standards and GCP requirements.
- Proven analytical skills that that can see/foresee problems and find resolution through collaborative relationships.
- Strong verbal and written communication skills.
- Relocation may be available to the right candidate.
We offer a competitive Total Rewards program including stock options, relocation support if required and employer supported benefit premiums. We thank you for your interest in Bellicum but please be advised that only those candidates selected to move forward will be contacted.