Senior Compliance Specialist, Facilities

Manager: Associate Director, Facilities
Department: Facilities
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.

JOB SUMMARY:   

Sangamo Therapeutics is seeking a Senior Compliance Specialist, Facilities to support cGMP requirements for design, installation, testing, calibration and maintenance of Process, Utility and Lab equipment/systems at the Brisbane clinical manufacturing facility.  This position will be support routine facility, utility, and equipment operations This position will participate in, coordinate, facilitate and/or manage the implementation of maintenance programs, systems, procedures, functions and processes needed to maintain GMP systems and equipment in compliance with regulatory requirements and established business and quality standards.

ESSENTIAL FUNCTIONS: 

• Compliance: Assess existing and planned processes, procedures, programs and systems for compliance to cGMPs and quality standards.  Make, prioritize, and implement recommendations for compliance improvements. Facilities POC and key contributor to inspection readiness team for audits and inspections.
   
• Business Process Management: Focus is Asset Lifecycle Management- Perform, coordinate, facilitate and manage business process requirements development, analysis, design and improvement. Document and recommend implementation methodology, standards, scope, and timeline estimates. Perform and document cost, risk, and benefit assessments.   Recommend and/or select technologies in partnership with technical groups. Act as liaison to Sangamo business units, technical support groups and associated Quality groups.
   
• Program Management: Manage and optimize Facilities Programs in a sustainable manner.  Supervise personnel and contractors as required. As assigned, manage program procedures, reports, audits and performance measures. Manage vendor qualification, on-boarding, and training.
   
• Information, Technology, & Knowledge Transfer: In all areas of responsibility, act as liaison to technical support groups and associated Quality groups. Solicit and coordinate the involvement of subject matter experts from other business units. Where appropriate, transfer existing technology, systems, programs, procedures and standards.  Communicate and leverage implementation experiences and results to continuously improve solutions transferred from other business units.  Where new solutions are developed, communicate implementation experience and results for consideration by other business units. 

• Project Management: Perform, coordinate and/or manage project planning, scheduling, budgeting, staffing, tracking, reporting, documentation, and execution. Represent Facilities GMP functions on engineering projects.  Ensure the work of project team members (both regular employees and consultants) meets company objectives. Turn over "turnkey" packages that include, where appropriate, historical data, manuals, procedures, process maps, training plans, drawings, staffing and budgeting plans, and business continuity plans.

EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:

• BA/BS in related scientific field preferred.  Will consider substantial and equivalent, on-the-job experience.  
• 5+ years’ GMP compliance operations experience including strong leadership and project and/or program management experience in a pharmaceutical manufacturing operations environment.
• Lean Six Sigma Green Belt or Black Belt Certification (preferred).
• Must have good oral and written communication skill.
• Proficiency in understanding of Federal, State, Local, and Sangamo regulations, procedures, and policies.
• Proficient with automation systems and software used at manufacturing facilities such as, BAS, PI, DCS, LIMS, and MCS.
• Advanced knowledge of facilities, maintenance and calibration best practices.
• Advanced knowledge of GMP, regulatory and change control requirements that applies to facilities, maintenance and calibrations.
• Advanced knowledge working with CMMS, CCMS systems.

OTHER QUALIFICATIONS:

• Technical writing skills for creating written procedures, best practices, standards and policies.
• Must be able to work in controlled or clean room environments requiring special gowning.
• Must be able to lift, carry, push and /or pull 50 lb. of equipment or supplies.
• Ability to mentally and physically react effectively, quickly, calmly and rationally in case of an emergency.

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.

COVID-19

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.