QA Manager/Sr. Manager, Quality Systems
Encoded Therapeutics is a therapeutics company combining the precision of gene regulation with the versatility of gene therapies to create breakthrough treatments for individuals living with severe genetic diseases.
We are recruiting a QA 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.
This position is part of the Quality group and will be responsible for the design, development, and implementation of the company’s quality management systems (QMS). The responsibilities include:
- Lead implementation and migration of paper based QMS to an electronic QMS (Veeva).
- 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.
- Partners with cross functional stakeholders and provides guidance to establish quality and compliance focused roadmaps. Collaborates with cross functional groups and provides oversight of quality systems development to meet business goals.
- 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.
- Continuously improves upon and manages Encoded’s document control program. Reviews and approves various 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.
- Manages a company wide training program.
- Designs, implements, and maintains the nonconformance and CAPA management systems.
- Identifies and classifies nonconformances, 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.
- Bachelor’s or Master’s 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.
- Demonstrated knowledge of quality management systems, processes, and procedures.
- Significant protocol writing and revision experience.
- Strong interpersonal and communications skills; written and oral
- Outstanding planning, organization and multitasking skills
- Team player and exhibit a willingness to meet project timelines.
- Extremely high degree of attention to detail
- Strong documentation skills
- Responsible and accountable with non-compromising high ethical standards
- Ability to translate complex issues into meaningful recommendations.
- Experience with AAV or gene therapies.
- Experience with QMS software platforms.
- Comprehensive 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 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 +1 650-491-0272.