Quality Assurance Manager/Senior Manager at Encoded Therapeutics in South San Francisco, CA
Encoded TherapeuticsSouth San Francisco, CA
Quality Assurance Manager/Senior Manager, Quality Systems Req 2014
Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit [ We are recruiting a Quality Assurance (QA) Manager/Sr. Manager to join our team. This is a unique opportunity to work at the intersection of genomics and therapeutics and participate in the development of a diverse therapeutic pipeline driven by a transformative core technology. The successful candidate will work well across multiple projects in a fast-paced and dynamic environment.
ResponsibilitiesThis position is part of the Quality group and will be responsible for the design, development, and implementation of the companys quality management systems (QMS). The responsibilities include:
Represents QA in functional team meetings; provides guidance and recommendations in alignment with regulatory requirements.
Maintains updated and relevant knowledge of the GMP landscape, regulations, and guidelines.
Author and revise QA related standard operating procedures and provides guidance for generation, review, and approval of process, equipment, test method, and other SOPs.
Provides quality oversight for qualification and validation activities including protocol generation, execution, and final report documentation.
Establish a formal procedure for the management of controlled documents. Reviews and approves all GMP related documentation including internal and external protocols, reports, test records, batch records, etc.
Establish a formal change control management system for GXP related activities. Review and approve change controls related to the implementation or revision of process, method, and/or equipment changes.
Implements and manages a companywide training program.
Designs, implements, and maintains the nonconformance and CAPA management systems.
Identifies and classifies non-conformances, deviations, OOS, OOT; collaborates with other departments for investigations and determination of root cause.
Oversees execution and completion of CA or PA activities.
Identifies opportunities for improvement, and drives continuous improvement initiatives.
Maintains equipment files, approves IQ/OQ/PQ protocol and reports, and ensures all applicable documentation is archived.
Trends and reports key quality metrics to the leadership team.
RequirementsBachelors or Masters Degree in relevant disciplines in life sciences. 8 years QA experience in a pharmaceutical or therapeutic environment; GMP experience is required.
Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH) Ability to thrive in a fast-paced dynamic environment with the ability to maintain objective and autonomous as it relates to quality and compliance.
Preferred ExperienceExperience with AAV or gene therapies is a plus.
Demonstrated knowledge of quality management systems, processes, and procedures Experience with QMS software platforms is a plus Preferred experience in pharmaceutical or therapeutic environments as a manager who can be a self-starter
BenefitsComprehensive benefits package, including competitive employer premium contributions Meaningful stock option grants PTO, sick time and holiday pay Generous Parental Leave program Pre-tax medical and dependent care programs STD, LTD, Life and AD&D Professional development opportunities Team-building events Fully stocked kitchen Purple Tie dry cleaning service Fitness center Encoded Therapeutics, Inc. is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages. If you need assistance or an accommodation due to a disability, you may call us at 1 .
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