Sr. Director/Vice President, Head Of Qa

Genascence
Job Title: Sr. Director / Vice President, Head of QA
Location: Palo Alto, CA
Full Time
Genascence Corporation is a clinical-stage biotechnology company developing life-changing gene therapy products for prevalent musculoskeletal diseases.
Osteoarthritis (OA) is the most common form of arthritis, affecting millions of people worldwide. GNSC-001 is a gene therapy viral (AAV) vector carrying a coding sequence for interleukin-1 receptor antagonist (IL-1Ra), a potent inhibitor of interleukin-1 (IL-1) signaling. IL-1 is considered one of the key mediators involved in the pathogenesis of OA, causing inflammation as well as cartilage destruction. GNSC-001 is designed to offer long-term, sustained inhibition of IL-1 following a single injection into the affected joint.
Why Work With Us
We are a growing enthusiastic team that recognizes each employee as a vital team member. Integrity and respect are fundamental to our working relationships.
Genascence is seeking a Sr. Director / Vice President, Head of QA to provide leadership and oversight of GxP vendors providing preclinical, manufacturing, and clinical trial services. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment.
Job Responsibilities

• Provide Quality Assurance oversight and support of ongoing GxP activities for clinical-stage development.
• Proactively identify compliance issues/risks within the organization and with external partners. Partnership approach with Project Teams and individual Departmental staff to provide guidance. Will be responsible for the management of the Quality department, including hiring and mentorship of QA staff and consultants.
• Lead Quality Management activities such as development of Quality Manual, Quality Management Plan, Quality Agreement with third party vendors, Vendor management and qualification
• Reports to the Chief Executive Officer and is responsible for advising executive management on developments in regulations and standards related to GxP quality that may impact company strategies and programs.
• Manage quality systems to ensure product reliability, quality, and efficacy through timely evaluation and review of Deviations, CAPA, and Change Control related to GLP, GCP, and GMP issues
• Establish and maintain training plans and matrix for employees and consultants
• Ensure compliance with established company quality policies, practices, standard operating procedures (SOPs) and regulations
• Establish an overarching corporate quality structure, including a scalable Quality Management System (QMS) through continuous development, implementation, and maintenance of quality standards, policies, and procedures that ensure regulatory compliance.
• Develop and maintain GxP Standard Operating Procedures (SOPs) policies and controlled documents in partnership with the teams.

Qualifications

• Experience in developing, implementing, and leading company-wide QMS (e.g., SOPs, training, change control, vendor management, development oversight, non-conformances and CAPA systems, and processes)
• Up to 30% of domestic/international travel may be required.
• MS or BS in life science with at least 15 years of industry experience in Quality Assurance for pharmaceutical, biotech, and CRO, including 8 years in a leadership role within the QA function, including GLP, GCP, and GMP Quality
• Outstanding interpersonal and communication skills, including scientific writing/editing, presentation, and verbal communication
• Expert knowledge of ICH, GLP, GCP, and GMP FDA regulatory requirements, with previous experience in the US and Europe
• Previous experience as Head of QA preferred

We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Learn more about working at Genascence at https://genascence.com.
Compensation: From $280,000.00 to $320,000.00 per year