Director/Senior Director, Quality Assurance
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 www.Encoded.com.
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 will work closely with cross functional teams including Manufacturing, MSAT, PD, QC, Supply Chain, Clinical Operations, and Regulatory and external CDMOs. The candidate will be responsible for providing leadership and supporting quality oversight of external GMP manufacturing and internal Quality systems related activities.
Workplace Model: Remote
- Provide functional leadership including hiring, managing, and developing quality assurance staffs to meet the technical and compliance requirements of a growing company.
- Oversee and lead all QA functions including Encoded QMS, Document Control, Training, Change Management, Deviation Management, Risk Management, Management Review, Supplier Quality Program, Audits, Product Release, etc.
- Responsible for strategic leadership and operational management of QA activities in manufacturing, testing, release, and product storage/distribution to support company objectives.
- Responsible for Quality and compliance oversight of GMP manufacturing activities at CMOs allow the timely disposition of Cell Bank, Plasmid, Drug Substance and Drug Product.
- Oversee and perform QA review of all internal and external and GMP lot release documentation including, but not limited to executed batch records, deviations, change controls, CAPAs, OOS, QC data, certificate of analysis, and other related documentation for compliance with established procedures, standards, and applicable regulations.
- Lead Quality Management Systems function in the development, maintenance and continuous improvements of internal Quality Systems processes and procedures.
- Oversee review and approval of SOPs, master batch records, protocols and reports for tech transfer, analytical method qualification, stability, reference standard, GMP sampling plans, label proofs, and product specifications.
- Review and approve process related deviations, CAPAs, and OOS. Partner and collaborate with Manufacturing, MSAT, PD, AD, and QC for complex investigations.
- Review and approve change controls related to process, analytical methods, and GMP systems.
- Represent the QA function in CMC team; support authoring and review of relevant CMC sections of regulatory filings (IND, IMPD, BLA, MAA, etc) as needed.
- Represents QA in functional team meetings; provides guidance and recommendations in alignment with regulatory requirements and guidelines.
- Review relevant GMP documents for compliance to approved written procedures (SOPs), quality systems, and applicable regulatory requirements.
- Provide QA support for QC, PD, MSAT, MFG, Supply Chain, and other cross-functional projects.
- Author and negotiate Quality Agreements with CMOs and partners.
- Maintains updated and relevant knowledge of the GMP landscape, regulations, and guidelines.
- Bachelor’s Degree in relevant disciplines in life sciences
- 10+ years of relevant industry experience with strong GMP QA expertise in Biologics and/or Gene Therapy manufacturing
- Strong GMP
- 5+ years in a QA leadership or management position
- Excellent knowledge of US and EU GMP regulations
- Direct experience with batch review and release of clinical and commercial products
- Experience managing contract manufacturing organizations
- Demonstrated knowledge of quality management systems, processes, and procedures
- Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH)
- Experience with IND and BLA submissions
- Strong interpersonal and communications skills; written and oral
- Outstanding planning, organization, and multitasking skills.
- Prior gene therapy experience is a plus
The anticipated salary range for candidates who will work in California is $213,000 - $244,000. 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 within the job, type, and length of experience within the industry, education, etc. Encoded Therapeutics is a multi-state employer and this salary range may not reflect positions that work in other states.
A hired applicant may be eligible for an annual bonus as well as equity under the company’s stock plan.
- 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
Employees (and their families) may obtain medical, dental, vision and basic life insurance benefits through the company and enroll in our company's 401k plan. Employees will also accrue vacation time off and paid sick time off and may become eligible for paid parental leave. Employees will also enjoy designated paid holidays throughout the calendar year.
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.