Manager: Sr. Director, R&D and Clinical Quality Assurance
Department: R&D and Clinical Quality Assurance
Location: Brisbane or Richmond, CA
Sangamo Therapeutics is a genomic medicine company building value with cutting-edge work across four distinct but complementary technology platforms – gene therapy, cell therapy, in vivo genome editing, and in vivo genome regulation. Using its deep scientific expertise and proprietary zinc finger genome engineering technology, Sangamo is working to create genomic cures for patients suffering from severe genetic diseases for which today’s medicines can only treat symptoms. At Sangamo, we are passionate about transforming lives by building a robust, sustainable, differentiated, innovative, and high value genomic medicine pipeline that addresses patients with life-limiting conditions. Sangamo takes pride in being the first to edit endogenous human genes, first to treat patients with gene edited T cells, and first to treat patients with in vivo genome editing. Our top priority is to meet the needs of patients with commitment and compassion. Along with our commitment to science and to our patients, we also endeavor to create an inclusive environment that promotes and values diversity. Sangamo is a company where individuals can flourish, grow and develop their expertise.
We are seeking top talent to join our mission. Let’s build a better future together.
The Associate Director, Clinical Quality Assurance (cQA) will be responsible for providing quality oversight for the clinical programs related to the company’s Zinc Finger Protein (ZFP) and Complementary DNA (cDNA) Therapeutic® products, including technology platforms for ZFP genome editing, Adeno-associated Virus (AAV) gene therapy and autologous & allogeneic Chimeric Antigen Receptor (CAR) Tregs. therapy.
The Associate Director, CQA will work with R&D, Pharmacovigilance, Quality Assurance and Clinical Operations to recommend and lead the implementation of quality initiatives to ensure clinical compliance to US FDA and international regulatory requirements and guidance, including Good Clinical Practices, Good Clinical Laboratory Practice (WHO), Good Laboratory Practice (21CFR58, OECD, etc.), clinical/medical laboratory requirements and accreditation standards (e.g., 42CFR493, ISO15189 and College of American Pathologist) and accreditation and guidance related to human bioanalytical analysis (e.g. USFDA, EMA, PMDA guidance and ISO17025 standards) and non-human bioanalytical analysis (e.g., 21CFR58, OECD GLP requirements). will lead or assist in GCP, GCLP, GLP vendor qualification and management efforts; will be responsible for creation and implementation of the clinical quality systems necessary to support Sangamo’s clinical trials goals to include (but not limited to) ongoing phase III clinical operations goals.
- Establishes, refines, implements, and maintains cQA systems, policies and procedures for oversight of the company’s internal clinical operations. Evaluate the company’s readiness for all phases of clinical research and current Phase III clinical trials and implement the systems necessary to comply with global regulatory requirements.
- Participates in clinical programs and coordinates the cQA interface with Contract Clinical Research Organizations (CROs), and Investigator Sites.
- Leads the clinical vendor qualification process program as it relates to functional areas responsible for the conduct of clinical research through on-site or remote audits and on-going monitoring of compliance to regulations and company policies.
- Ensures implementation of a risk-based approach to regulatory compliance as it relates to clinical research activities, through ongoing assessment of the clinical development portfolio, review/audit of essential documents (e.g., protocols, clinical study reports, etc.), identification of investigator sites that may pose a risk to that portfolio, conducting regular investigator site audits and management of subsequent corrective and preventive actions plans (CAPA).
- Manages the internal audit process, reporting and CAPA management of Sangamo’s functional areas that directly impact compliance to GCP, GCLP and GLP.
- Manages Deviations related to functional areas that directly impact compliance to GCP including reporting on investigations, clinical impact, and resolution to Senior Management.
- Acts as a subject matter expert (SME) and provides advice and interpretation of regulations and guidelines.
- Participates in the review, audit and/or approval of GCP defined essential documents such as Clinical Protocol, Informed Consent, Pharmacy Manual, Clinical Investigator’s Brochure, Clinical Study Report audits, etc.
- Supports the organization’s training program as it relates to GCP, GCLP and GLP and compliance
- Supports regulatory inspections of the company and its clinical vendors as needed.
- Provides cQA support for safety related monitoring and pharmacovigilance. Supports the Quality Assurance Unit in other tasks necessary to maintain GxP Quality System Participates in the validation and implementation and deployment of GxP compliant electronic systems in support clinical research activities.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
- Minimum of a bachelor’s degree in life science or equivalent
- Demonstrated in-depth experience of establishing, refining, and operating Clinical Quality Assurance related systems in the Biotechnology industry.
- At least 5-8 years’ experience in a combination of clinical Quality Assurance and Clinical Operations roles within a regulated industry
- In depth knowledge of regulations and guidance supporting GCP to include (but not limited to): US FDA, EMA, MHRA, ISO standards and ICH guidelines with direct impact to clinical programs including cell-based, gene-based, and rAAV-based therapies.
- Excellent interpersonal and collaboration skills Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
- Ability to travel, post COVID, up to 30% both domestically and globally
- Must be local to the San Francisco Bay area
Sangamo is an equal opportunity employer
The above reflects management’s definition of essential functions for this position but does not restrict the tasks that may be assigned. The above duties are representative only; management may assign or reassign duties and responsibilities to this position at any time.
Sangamo requires all U.S. workers to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at Sangamo, and it applies regardless of location or classification of role. If you are unable to receive the vaccine, you will have an opportunity to request a reasonable accommodation consistent with applicable laws.
Note to External Recruiters: Please understand that we do not accept unsolicited resumes from any source other than from the candidates themselves. Any agency or independent recruiter must have a signed copy of our agency agreement before presenting candidates. Submission of unsolicited resumes without our signed agreement will not create any implied obligation on our part.