Quality Systems & Compliance Manager

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.
• Provide quality oversight and compliance support to implement and validate GxP electronic systems in accordance with the CSV procedures and regulatory requirements.
• 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.