- Job Type: Full-Time
- Function: Life Sciences QA/QC
- Industry: Biotechnology
- Post Date: 09/19/2022
- Website: tenayatherapeutics.com
- Company Address: 171 Oyster Point Blvd, South San Francisco, California , 94080
About Tenaya TherapeuticsTenaya Therapeutics is a developer of novel therapies designed to offer treatment for heart disease. The company's therapies address heart failure through multipronged efforts that target the fundamental cellular pathologies present in diseased cardiac muscle and that leverage cutting-edge research in cardiac development and regeneration,enabling physicians to regenerate heart tissue, and additional programs focused on cardiomyopathies.
The Director of QA Good Clinical Practices (GCP) will be responsible for all aspects of Quality Assurance GCP activities to ensure quality assurance and compliance of Tenaya sponsored clinical trials with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Tenaya Standard Operating Procedures (SOPs), and current industry standards and practices.
- Work collaboratively with internal Clinical Operations Team to ensure compliance standards are achieved
- Manage GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines
- Review and approve Clinical SOPs. In addition, develop and implement Clinical QA SOPs
- Ensure the timely and effective follow-up of all identified quality issues
- Conduct QA oversight of GCP protocols, Clinical Study Reports (CSRs), and other clinical trial-specific documents as requested
- Perform CSR audits and eTMF audits. Prepare written audit reports and communicate findings and recommendations and evaluate the adequacy and completeness of corrective and preventative action plans
- Work closely with Clinical Development, Clinical Operations, PV/Safety, and other departments to ensure compliance readiness
- Provide leadership in inspection preparedness to clinical sites, GCP vendors for BIMO inspections, and inspections by other regulatory government agencies
- Support process improvement initiatives; Lead continuous process improvements within Quality
- Maintain required knowledge of applicable regulations, guidelines and company standards and procedures
- Bachelor’s Degree or advanced degree in a scientific discipline; Quality assurance professional certification is a plus
- Minimum of 10+ years’ current work experience in pharmaceutical industry Quality Assurance required
- Demonstrated Quality Management System experience (GCP specific QMS experience preferred)
- Demonstrated Issue Management and CAPA experience in a clinical environment
- Experience with FDA or other Regulatory Inspections of Investigator sites, Sponsors or CROs
- Strong leadership with demonstrated ability to interface with senior leaders and different levels of organization
- Solid understanding of GCP and ICH clinical requirements
- Excellent written/oral communication skills and interpersonal skills to build key networks and business relationships across all levels of the business
- A self-starter and a team-player who thrives in a fast-paced dynamic team environment
- Knowledge of Microsoft Office applications, Adobe, DocuSign, and Veeva and working experience with EDC, eTMF systems
We offer a dynamic start-up environment, and a collaborative, passionate team focused on a compelling vision and mission.
We offer a competitive salary and stock options. Excellent medical and non-medical benefits. Paid vacation, sick time, and holidays.
State-of-the-art, built-to-suit office and lab space, part of a larger cluster of biotech companies, with amenities that include a bowling alley and onsite gym.
Shuttle service to/from Caltrain, BART, and the South San Francisco Ferry.
Tenaya is proud to be an equal-opportunity workplace.