Senior Manager External Quality and Product Release
Senior Manager External Quality and Product Release
Posted on :
06-04-2025
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1 Vacancy
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Job Description
Title: Senior Manager External Quality and Product Release
Manager: Director External Quality and Product Release
Department: Quality Assurance
Location: Brisbane or Richmond (Hybrid)
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases by using our wholly owned highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo we are dedicated to building a robust sustainable genomic medicine pipeline that addresses lifelimiting conditions by replacing todays symptomfocused treatments with tomorrows genomic cures. 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. Lets build a better future together.
JOB SUMMARY:
Sangamo Therapeutics is seeking a Senior QA Manager who will be responsible for providing Quality support to external manufacturing activities. The individual will work with contract manufacturing and internal functions to ensure quality and compliance in support of Sangamos CMC development programs. This individual will develop and execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
ESSENTIAL FUNCTIONS:
Manager: Director External Quality and Product Release
Department: Quality Assurance
Location: Brisbane or Richmond (Hybrid)
Sangamo Therapeutics is a genomic medicine company focused on treating debilitating neurological diseases by using our wholly owned highly versatile zinc finger epigenetic regulation technology and capsid delivery engine. We are passionate about designing and developing genomic medicines to transform the lives of patients suffering from severe diseases with our deep scientific expertise and proprietary zinc finger genome engineering technology. At Sangamo we are dedicated to building a robust sustainable genomic medicine pipeline that addresses lifelimiting conditions by replacing todays symptomfocused treatments with tomorrows genomic cures. 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. Lets build a better future together.
JOB SUMMARY:
Sangamo Therapeutics is seeking a Senior QA Manager who will be responsible for providing Quality support to external manufacturing activities. The individual will work with contract manufacturing and internal functions to ensure quality and compliance in support of Sangamos CMC development programs. This individual will develop and execute based upon implemented quality systems / standards. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.
ESSENTIAL FUNCTIONS:
- Oversee and manage contract manufacturing organizations (CMO)
- Perform PersoninPlant duties as required
- Liaise with CMO Quality partners to communicate QA policy and procedures
- Interfaces with contract manufacturers to address documentation and compliance issues
- Interfaces with crossfunctional teams to resolve quality or system issues
- Collaborate with CMOs to support investigation teams to resolve equipment and process related deviations
- Support disposition of finished drug product batches
- Review batch records associated testing records and other documentation to ensure that all steps have been executed correctly verified where applicable and that all limits and specifications have been met
- Review and approve GMP documentation (master test records master batch records deviations change controls specifications technology transfer protocols/reports and various other protocols/reports to support GMP production etc.
- Review and approve validation protocols/reports to ensure compliance
- Review protocols analytical results and documents associated with investigations OOS results retest plans etc. and associated corrective/preventive action plans
- Review stability protocols/reports
- Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required
- Provides assistance during both internal and regulatory agency audits as required
EDUCATION EXPERIENCE AND SKILLS REQUIREMENTS:
- Bachelor of Sciences (BS)degree or equivalent in a technical discipline (physical engineering chemical or biological sciences) is required
- 8 years of experience in a Quality Compliance and/or Regulatory setting
- 4 years in a QA review role and preferably direct work experience in either Manufacturing or QC as well.
- Strong attention to detail organization and communication skills
- Indepth knowledge of FDA ISO EMA GMP and ICH quality systems and regulatory requirements ideally for ATMPs
- Experience with cellbased genebased and rAAVbased therapies a plus
- Proficiency with eQMS/eDMS (Veeva and Office365 preferred
OTHER QUALIFICATIONS:
- Excellent interpersonal skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fastpaced multidisciplinary industrial environment
- Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments
- Ability to travel domestically <10.
- This position can be located in either our Brisbane CA or Richmond location and may require occasional travel to the other site as needed. There is flexibility for a hybrid schedule that allows partial remote work.
We are only considering candidates who are local to the San Francisco Bay Area. Relocation is not available for this role.
We encourage you to apply even if you dont meet all the qualifications. We believe in the value of diverse perspectives and backgrounds and we welcome candidates who are eager to learn and contribute to our mission.
Sangamo is an equal opportunity employer
Sangamo is committed to fostering belonging for all employees and embraces diversity equity and inclusion in recruiting and hiring. All qualified applicants for employment are encouraged to apply and will be considered without regard to an individuals race color sex gender identity gender expression religion age national origin or ancestry citizenship physical or mental disability medical condition family care status marital status domestic partner status sexual orientation genetic information military or veteran status or any other basis protected by federal state or local laws.
Commitment to Safety
Sangamo requires all U.S. workers to be fully vaccinated against COVID19 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.
Pay Range
The anticipated salary range is for candidates who will work in our San Francisco Bay Area work locations. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience with the job type and length of experience within the industry education etc. This salary range may not apply to remote positions that work in other states.
Note to External Recruiters: We do not accept unsolicited resumes from any source other than from the candidates themselves. If you wish to be considered for the presentation of candidates please email We will reach out to you directly if there is a business need for your services.
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Required Experience:
Senior Manager
Employment Type
Intern
Key Skills
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