Sr Manager, QA Validation
Manager: Senior Director, Quality Operations
Department: Quality Assurance
Location: Brisbane, 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 Manager/Senior Manager, QA Validation will provide oversight to validation activities required to commission and maintain Sangamo Therapeutics’ Brisbane, CA facility. Working with Validation Team this position will maintain Sangamo’s Validation Program supporting in-house manufacturing and testing for our portfolio of Cell Therapy and Gene Therapy products.
This position will be required to lead a QA Validation team that can expand and contract (through a mix of FTEs and consultants) to complete qualification of the facility and transition into maintenance mode, while also maintaining access to various highly specialized validation experts to support future projects.
- Responsible to ensure that Validation activities are adhering to cGMPs, internal procedures and international regulations/guidelines.
- Maintains Validation Program, inclusive of Validation Master Plans and standards for Validation Documentation, plus corollary SOPs.
- Provides Quality oversight to the maintenance and validation of the company’s in-house manufacturing and testing facilities, as well as design, construction, commissioning for any future projects.
- Provides guidance and review of external validation activities to ensure that CMOs are meeting Sangamo standards/expectations.
- Evaluates validation impact of manufacturing process changes, equipment upgrades, deviations and product nonconformance events.
- Works closely with Validation Leader, oversees the work of validation contract support.
- Identifies, manages and oversees work of external Consultants performing work on behalf of Sangamo, as needed.
- Directs initiatives that accomplish continuous improvement and cost effectiveness and enhance the efficiencies and the compliance of GMP operations.
- Other activities may be assigned.
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS
- Minimum of a Bachelor’s degree in life sciences or equivalent and possibly a MA or Ph.D. in biological sciences, bioprocess engineering, validation sciences or related discipline.
- Demonstrated in-depth expertise of establishing, refining, maintaining and/or overseeing Validation Programs for the Pharmaceutical industry.
- Minimum of 4 years experience in progressive management of QA departments or validation departments in the biotechnology or pharma industry.
- Minimum of 8 years working in a FDA regulated industry.
- Proven track record of management of QA Validation for in-house and/or CMO-based GMP production operations.
- In-depth knowledge of FDA, ISO, EMA, GMP, GAMP and ICH quality systems and regulatory requirements for ATMPs, including cell-based, gene-based and rAAV-based therapies.
- Experience with new production facility design, construction, commissioning and operation preferred
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment.
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.
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.
If you wish to be considered for the presentation of candidates, please contact us through Recruiting@sangamo.com. Attach your contact information, your area of specialty, and any marketing information you wish to provide. Someone from the Talent Acquisition Department will contact you directly if there is a business need for your services.