Associate Director, Quality Systems
Our client is a rapidly expanding clinical stage biotech developing targeted immunotherapies for both cancer and infectious disease. Their approach is to generate therapeutic immune response through leveraging insights into our immune system's ability to identify and remove diseased cells by targeting specific antigens. They believe that activating and directing the immune system to such targets could lead to significant progress in the delivering the advantages of immunotherapy to a greater number of patients.
We are currently recruiting for an Associate Director of Quality systems for their Pleasanton, CA location. As the AD, you will support the drug product manufacturing process and assure that Quality Systems are implemented in a phase appropriate manner meeting Regulatory and Quality requirements.
- Develop and maintain a GMP compliant document control function with appropriate processes, procedures, and practices.
- Implement/manage the corporate Training System and training records. Work with department heads to develop training curriculums for all GxP personnel.
- Implement/manage the corporate Quality Audit Program and track observations and coordinate responses with appropriate department managers.
- Maintain/Manage Master Control Electronic Quality Management System for Document Management, Deviation Management, Change Management, Vendor Management, and electronic Batch Records.
- Prepare for and Manage the Quality Management Review (QMR) meetings
- Create and maintain monthly QA metrics reports.
- Provide QA system support during regulatory inspections with document retrieval function, inspection logistics oversight; other functions as required.
- Represent Quality Assurance at meetings as appropriate.
- Support technical transfer of GXP documents and records between functional groups and across sites with suitable documentation functions.
- Provide QA expertise, advice, or assistance to other departments as required.
- Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.
- Manage direct reports as necessary to support the Quality Systems function.
Skills and Requirements:
- BS/BA or MS in life sciences and at least 10 years of experience in quality operations or development in the biotechnology or pharmaceutical industry.
- Experience with quality systems for development and commercial production.
- Experience establishing and managing Document Management Systems
- Experience with regulatory inspections.
- Knowledge of FDA regulatory requirements for biologics or pharmaceuticals including US FDA CFR Parts 210 and 211, ICH Q7 and Q10, EU Directive 2001/20/EC.
- Experience performing cGMP audits of both internal and vendor manufacturing is preferred.
If you are having difficulty in applying or if you have any questions, please contact Proclinical at QualityAssuranceJobs@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.