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Quality Systems & Compliance Manager (Computer Systems Validation & Data Integrity)

Employer
Adicet Bio, Inc.
Location
Redwood City, CA
Start date
Sep 18, 2023

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Discipline
Quality, Quality Control, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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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.

Quality Systems & Compliance Manager (Computer Systems Validation & Data Integrity)

Quality Systems & Compliance (QS&C) Manager will be responsible for the implementation, maintenance, continuous improvement, and effectiveness of Adicet’s Quality Management System (QMS) processes.   Role will provide compliance oversight of QMS processes to ensure quality system processes are compliant with procedural and regulatory requirements.

Primary responsibilities are to provide Quality oversight on Computer System Validation (CSV) and serve as the site’s Data Integrity Business Process Owner. As needed, the role will provide support and serve as Business Process Owners for other quality systems.

Key responsibilities:
  • Support/Lead implementation of quality system processes and ensure continuous improvement while keeping current with regulations, guidance documents and industry best practices.
  • Work cross-functionally to ensure alignment, maintenance, effectiveness, and compliance of Adicet’s hybrid (electronic and paper-based) QMS.
  • Implement, maintain, and continuously improve Adicet’s Data Integrity Program. (Required experience) Provide quality oversight and compliance support to implement and validate GxP electronic systems in accordance with the CSV procedures and regulatory requirements. (Required experience)
  • Support/Lead data integrity gap assessment for new and existing regulations/guidances. Identify gaps and collaborate with functional owners to propose remediation plan(s).
  • Support/Lead audits including preparation, execution, reporting, and follow up to any findings.
  • Support inspections and inspection readiness activities to ensure Adicet maintains compliance with regulatory requirement.
  • Support trend analysis and Key Performance Indicators (KPI).
Qualifications:
  • BS preferred or related experience in life sciences or computer engineering.
  • Five years of experience in Quality Assurance/Systems, computer systems validation or related role within the biotech/pharmaceutical and/or cell/gene therapy industries.
  • Strong knowledge of GxP, ICH, EU and CFR requirements and regulations. Experience with GAMP, 21 CFR Part 11, and Annex 11.
  • Experience in developing validations strategies and computer system validation.
  • Experience in supporting/leading audits and inspection readiness.
  • Strong interpersonal, oral/written communication, collaboration and influencing skills.
  • Ability to lead cross-functionally across various levels of experience and management.
Benefits

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.

Pay Range$127,000—$176,000 USD

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.

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 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.

Company

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.

Company info
Website
Location
1000 Bridge Parkway
Redwood City
California
94065
United States

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