Senior / Director, Quality Systems and Compliance
- Adicet Bio, Inc.
- Redwood City, CA
- Start date
- Mar 22, 2023
- Quality, Quality Control, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Biotech Bay
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs) and adaptors (CAds), to enhance selective tumor targeting and facilitate innate and adaptive anti-tumor immune response for durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.SENIOR / DIRECTOR, QUALITY SYSTEMS and COMPLIANCE
Adicet Bio is seeking an experienced Quality Assurance professional will be responsible to assess and monitor the health of the QMS for continuous improvement, while also leading cross-functionally in order to build a culture of quality across the internal and external manufacturing sites. This leader will oversee quality systems and health authority inspections, internal audit program, document control, records management and training for the manufacturing site. Reporting to the Quality Head, the Director Quality Systems and Compliance will be responsible for implementing world class quality system processes and operations to ensure Adicet Bio exceeds the highest level of compliance. This leadership role provides strong strategic direction for the application of Adicet’s Quality Management System (QMS) expectations in support of manufacturing for Adicet clinical drug product and excipients.
In this key position, the individual will develop, implement, manage, and maintain GxP (cGMP, GCP, and GLP) quality systems and will work across all disciplines (e.g., process development, manufacturing, clinical development, research, and regulatory affairs) to ensure that Adicet’s ongoing development program maintains regulatory compliance with local, state, federal, and international health authority requirements. Adicet’s development programs involve novel cell therapies which present opportunities for unique product manufacturing, quality, and regulatory strategies. The ideal candidate should have experience in the area of cell therapy and/or biologics and knowledge of the pertinent regulations and how they apply to these fields.
- Implement Adicet’s overall Quality Management System (QMS) and quality manual, policies and procedures for the site. Ensure continuous improvement while keeping current with emerging and changing regulations, guidance documents and industry best practices and expectations.
- Provide cross functional quality leadership and act as a GXP compliance subject matter expert. Serve as the site’s Quality process owner for, at a minimum, Deviation Management, Change Management, Notifications to Management / Escalations, Material Review Boards, Complaints, Quality Management Reviews, and Health Authority reporting.
- Oversee the performance and effectiveness of the QMS programs listed as well as Quality Risk Management, Training, Documentation and Records Management, and Data Integrity. Lead Management review meetings and monitor the state of control of Adicet’s QMS in the internal and external manufacturing sites.
- Evaluate business goals, identify improvement opportunities, utilize critical thinking, and apply problem-solving techniques to improve and sustain product quality and process effectiveness in the overall QMS lifecycle.
- Support regulatory filing requirements for INDs, CTAs, NDAs and other regulatory compliance communication.
- Work with manufacturing quality assurance and technical functions in batch record audits and assure proper batch release and/or disposition.
- Oversee audits/inspections, including preparation, execution, reporting, and follow up to any finding.
- Provide trend analyses, and KPI/metrics to peers and senior management.
- Review and approve development study protocols and reports.
- Organize and implement a training program for Adicet staff to maintain compliance with regulations and SOPs.
- Scientific degree (chemistry, biology, pharmacy or related, pharmaceutical or engineering sciences).
- At least 8 years of experience managing the quality aspects of cell therapy and / or biologic products, including manufacturing and technical qualification, analytical testing, and product release in a clinical stage pharmaceutical or biotechnology company.
- Excellent working knowledge of cGMPs, FDA regulations (21 CFR Parts 210, 211), ICH Guidelines and practical experience in auditing practices and procedures.
- Working knowledge of GLP, GCP, GTP, GDP and relevant ICH guidelines preferred.
- Strong supervisory skills with ability to thrive in a matrix environment.
- Self-motivation, good judgment, strong follow up, organizational, analytical, and problem- solving skills.
- Strong team orientation, with excellent written and oral communication skills.
- Other: Identify and support a Qualified Person (QP) in accordance with directive EC/2001/83, when required.
At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting cancer.
We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match.
To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs.
We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 12 company holidays with end-of-year shutdown, vacation, sick time, and paid parental leave.
Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, abundant, zero-cost, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company subsidized lunches (delivered onsite daily) and fully stocked breakrooms.
In compliance with California’s pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open positions. The pay scale range for this role is $162,000 - $283,000 annualized base salary. The salary of the finalist selected for this role will be set based on a variety of factors, including but not limited to, their qualifications (education, experience, specialty, and training), and peer and market data. This listed salary range represents the Company’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
Adicet Bio, Inc. is a privately held, pre-clinical stage biotechnology company developing novel universal immune cell therapies based on gamma delta T cells engineered with Chimeric Antigen Receptors. Adicet is also focused on identifying and validating cancer specific targets directed to the intracellular proteome and then generating T Cell Receptor-like monoclonal antibodies (TCRLs) directed to these cancer-specific peptide targets presented by MHC Class I complexes. These TCRLs are being used to arm T cells or as T cell engagers in solid tumors. In August 2016, Adicet entered into a strategic collaboration with Regeneron Pharmaceuticals, Inc. to develop next-generation engineered immune-cell therapeutics using Adicet's gamma delta T cell allogeneic platform technology.
For more information, please visit our website at http://www.adicetbio.com.
200 Constitution Drive
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.Create alert