Quality Assurance Operations Manager (GMP)
Are you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio!
AmplifyBio is a company dedicated to building an integrated environment where clients can access technologies, platforms, capabilities and safety testing for the scale up and commercialization of advanced therapies. We began as a CRO, spun out from the Battelle organization in West Jefferson, Ohio and are now proud to have added a site in South San Francisco dedicated to discovery, optimization, and characterization of client drug candidates.
The platforms and domain expertise at our San Francisco site fills the critical gap that exists between discovery and the clinical scale up of drug development. The team here is dedicated to helping clients understand the biological and immunological mechanisms and characteristics of their advanced therapies to ensure product consistency and prevent unexpected failures downstream.
We partner with our clients, leveraging state of the art technologies and platforms we will enable our customers to accelerate and improve the product development cycle, from concept to commercial.
When you join our team, you will be a part of groundbreaking work while collaborating with our clients, research scientists, study directors, lab technicians and specialists across a variety of disciplines. Our chemists, biologists, veterinarians, data scientists, engineers, pathologists, and other experts collaborate to deliver new and exciting breakthroughs. The future for AmplifyBio is as great as the combination of our imaginations and actions, and we hold ourselves accountable for our choices and results. We have a bias for action, excellence, and, especially, the health and safety of our employees.
AmplifyBio’s next step forward in advancing medical breakthroughs, treatments, and cures for disease is to establish a Cell & Gene Therapy (CGT) manufacturing and development facility. We are seeking highly motivated individuals to help create and define a first-of-its-kind CGT facility at our new site in South San Francisco, CA.
AmplifyBio is seeking to hire a Quality Assurance Operations Manager to join our growing team!!!
The ideal candidate is an experienced Quality Assurance Operations Manager with a track record of success in GMP environments who understands biologics processes (i.e. cell & gene therapy, aseptic environments, reagent control, contamination control).
What You’ll Do Here:
The candidate will be responsible for the following in support of maintaining the highest quality products:
- Manage daily QA operations at AmplifyBio’s South San Francisco site in support of cell & gene therapy manufacturing activities.
- Provide coaching and mentoring to junior staff.
- Review and approve all GMP documentation including SOPs, batch records, deviations and investigations, QC testing, study reports, validation/qualification protocols and summary reports, etc.
- Provide document review and feedback for CAL/PM program and Environmental Monitoring for the site.
- Manage and trend lot/product disposition activities.
- Define quality metrics, analysis trends, and report client (product) specific quality metrics for quality management review as required.
- Provide training and guidance on Quality topics to foster a quality culture and quality mindset (i.e. Good Documentation Practices).
- Manage the Material Review Board program for in-house and purchased materials.
- Provide compliant investigations, review and approve investigations as needed.
- Provide overall direction to Quality and non-Quality personnel performing raw material review and release activities, analytical data reviews and general analytical support.
- Maintain tracking databases associated with data review and lot disposition activities.
- Support finished product shipments to clinical site in conjunction with logistics/clinical and supply chain functions.
- Support Tech Transfer activities for new projects.
- Participate in quality audits in support of GMP operations and regulatory requirements.
- Partner with Program Management, Manufacturing, Quality Control, Supply Chain and attend meetings in support of relevant manufacturing programs and activities.
- Present data during department and cross-functional meetings as needed.
- Perform other activities as required based on company needs.
We Would Love to Hear From You If:
- A Bachelor’s degree or higher in a relevant scientific discipline – Bioinformatics, Biology, Biochemistry, Chemistry or other relevant area.
- A minimum of 8+ years of experience in Quality and GxP biotechnology or pharmaceutical environment with supervisory responsibilities.
- Understanding through prior experience of GMP regulation and guidelines related to the conduct of early phase clinical programs such as, 21 CFR Part 210 and 211.
- Must have extensive cGMP quality system knowledge and experience.
- Experience using and or managing eQMS, such as MasterControl or Veeva
- Strong interpersonal skills, ability to work in a team environment, attention to detail and excellent problem resolution skills.
- Strong teamwork, leadership, organization, and communication skills.
- Experience in cell & gene therapy is a plus.
At AmplifyBio, we’re committed to growing and empowering an inclusive community within our company and industry. This is why we hire and cultivate diverse teams of the best and brightest from all backgrounds, experiences, and perspectives across our organization. Research shows that oftentimes women and minority groups only apply to open roles if they meet 100% of the listed criteria. AmplifyBio encourages everyone — including women, people of color, individuals with disabilities and those in the LGBTQIA+ community — to apply for our available positions, even if they don’t necessarily check every box on the job description. Hire for attitude and train for aptitude creates unique opportunities to build strong teams of smart, motivated individuals who love what they do.
AmplifyBio is an equal opportunity employer, and we value diversity at our company. We don’t discriminate on the basis of race, color, citizenship status, national origin, ancestry, gender (including gender expression and gender identity), sexual orientation, age, weight, religion, creed, physical or mental disability, marital status, veteran status, political affiliation, or any other factor protected by federal, state, or local law. AmplifyBio will not tolerate discrimination or harassment based on any of these characteristics. If you have a disability or special need that requires accommodation, please let us know during the recruiting process. We are committed to the safety and wellness of our employees and customers. Therefore, COVID vaccination is required.
Why You Will Love Working Here:
We take the health and happiness of our employees seriously and consistently evaluate new ways to Amp up our benefits to provide an amazing place to work. From a wellness program, to financial planning and legal assistance, we make sure to take care of our own.
- Health, Dental, and Vision insurance that starts on your first day at AmplifyBio
- Competitive Compensation Package
- We take work-life balance seriously and we back it up with generous PTO
- Life and AD&D insurance
- Supplemental insurance
- LiveHealth Online
- Smart Shopper (helps you shop for better medical care and earn cash rewards while you save)
- Generous paid parental leave
- Wellness and Self-Care Programs
- 401(k) match
- Tuition Reimbursement
- EAP/work-life support system
- A fun work environment where everyone’s voice matters
- We are just getting started! More benefits on the way!
- An Opportunity to Change the World!!!