Manager, Quality Assurance (Audit & Supplier Quality) *PC 484

Your Role:

This position is primarily responsible for establishing and managing the Bioindustry Quality System with respect to leading strategic quality initiatives that strengthen compliance, drive risk-based auditing, and enhance supplier quality oversight across a global network of sites and suppliers.

Oversee the execution of qualification, maintenance and monitoring of Lentigen Operations suppliers, with an emphasis on continuous improvement, global alignment, risk management and supply chain reliability.

Support inspection readiness for outsourced GxP operations, including regulatory and internal audit preparation.

Provide leadership, mentorship and oversight to the Audit and Supplier Quality function and develop people and teams.

This role will influence GMP manufacturing activities and enterprise-wide quality strategy, improve inspection readiness, and proactively identify and mitigating risks that impact product quality and patient safety. Success in this role will be measured by the effectiveness of audit and supplier quality programs, regulatory compliance, risk reduction, and the development of a high-performing team that support operational excellence.

Essential Duties & Responsibilities:

• Participate in a lead role in internal, external and regulatory authority audits, including the timely preparation of audit reports and responses to audit findings. Coordinates and hosts client and regulatory authority inspections, as required. This includes audit strategy, prioritization, planning, execution, reporting, and governance.
• Prepare/assess quality audit findings with respect to required corrective actions and ensures timely reporting to QA leadership and conducts follow-up.
• Monitor audit results, compliance trends, quality risks, and inspection outcomes to identify systemic issues and inform risk-based quality decisions. Communicate quality program performance, risks, and key priorities to senior leadership.
• Oversee the audit team, including auditor qualification, development, and program effectiveness.
• Lead and collaborate with site and functional leaders to support inspection readiness, remediation activities, and ongoing compliance improvement efforts.
• Lead the Quality Agreement program.
• Establish goals for the Supplier Quality department according to the global and site strategy and take action to ensure timely delivery of goals.
• Support quality oversight of CDMOs, CROs, labs, consultants, and other outsourced service providers.
• Oversee maintenance of the Approved Supplier List (ASL)
• Lead supplier risk management activities to mitigate supplier impact to Lentigen (audit failures, refusal to comply with qualification requirements, introduction of excipients in technical transfer projects)
• Program manage improvement projects to streamline existing cross functional workflows for reduction of errors and time to completion. This includes New Supplier Requests (NSR), supplier-related Deviation investigations, Supplier Notifications (SNC)/ Supplier Alerts