Senior Director, Quality Assurance (AH17-169)
Summary of the Position
Catalyst Biosciences is seeking a Senior Director, Quality Assurance in their South San Francisco office. This position will report to the SVP, Technical Operations and has primary responsibility for managing quality assurance for the Company’s programs. Catalyst is advancing several high potency parenteral recombinant compounds, targeted for subcutaneous delivery, through mid-to-late clinical trials with the intent of commercializing.
- Establish and maintain quality systems and implement process improvements as needed to ensure GMP, GLP, and GCLP compliance in a clinical development environment that will evolve and support a fully approved commercial product
- Provide quality oversight of external GMP activities associated with CMOs (DS & DP), CROs and key suppliers of raw materials
- Ensure the adequacy and availability of both internal and external GxP and program-level training, including providing training as needed, e.g., new regulations, audit findings, etc.
- Manage quality assurance programs, as appropriate for internal and external activities
- Serve as a resource for quality and compliance questions, issues, and planning, including providing guidance based on current GMP global regulations, industry standards and best practices
- Provide oversight and assist internal and external personnel, in the development of corrective and preventative action plans following identification of compliance issues and/or concerns. Monitor progress on successful completion. Review Deviations, Corrective Actions, Change Controls, Batch Records, Test Records and other QA-Controlled procedures
- Participate in outsourcing vendor evaluation and selection, conduct vendor audits, ensure robust vendor oversight and establish quality agreements
- Set up and maintain GxP documentation storage area
- Lead inspection activities (preparation, conduct, and response) for internal CMC / GMP regulatory inspections
- Facilitate internal reviews of processes, assist in preparation of responses to findings and ensure completion of commitments
- Participate in preparation, review and approval of CMC sections of regulatory filings
- Participate in due diligence audits of potential business partners
- Manage CMC / GMP audit program for CBIO, CMOs (DS & DP), GMP CROs and key suppliers utilizing cGMP knowledge and findings to improve procedures and quality compliance standards
- Maintain awareness of new developments for cGMP and inform management of potential impact to clinical programs and business processes
- Travel globally to CMO, CRO and key vendor sites to represent Catalyst for quality assurance oversight and partnership development purposes, as required
- Partner with key Catalyst functions including Manufacturing, Project Management, Clinical Operations, Finance and Regulatory Affairs
- Prepare multi-year project budgets. Manage activities to agreed yearly budget. Partner with Finance Department.
- A BA/BS, MA/MS or PhD in a scientific discipline or related field
- Minimum ten years’ experience in a Quality function with increasing levels of responsibility in the biotech/pharmaceutical industry
- In-depth knowledge and experience implementing phase-appropriate quality assurance systems to achieve and maintain GxP compliance
- Strong understanding and interpretation of GMPs, GLPs, GCPs and best quality practices with regard to biotech and parenteral pharmaceutical products
- Experience with regulatory agencies such as the FDA, EMEA, etc.
- Direct experience with GMP as well as clinical and commercial quality assurance
- Proven success in CMO management (DS & DP) with clinical products
- Technical expertise in development of recombinant biologic parenteral products
- Ability to effectively manage vendors globally
- Excellent communication skills, both written and oral
- Demonstrated ability to work effectively in a team-oriented environment
- Demonstrated skills in Catalyst’s Core Competencies:
- Drive, Intensity, Enthusiasm
- Goal Orientation/Commitment to Task/Follow-up
- Attention to Quality & Detail
- Decision Making & Problem Solving
Thank you for your interest in Catalyst Biosciences! You may apply for this position by sending your CV/resume to firstname.lastname@example.org, referencing requisition number AH17-169 in the subject line.