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

Miltenyi Biomedicine•Gaithersburg, MD

55d•$110,026 - $129,413•Onsite

About The Position

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.

Requirements

Bachelor's degree in Life Sciences, Engineering, or a related technical field; 8 + years of overall experience in Quality, Regulatory Affairs, Manufacturing, or a related regulated industry, including 3+ years of leadership experience with auditing and supplier quality experience.
Prior experience within pharmaceutical and/or biologics manufacturing environments is preferred.
Strong knowledge of global regulatory requirements governing biologics manufacturing, with familiarity in pharmaceutical and biologics regulations preferred.
Demonstrated success leading a quality, compliance, regulatory, or manufacturing organizations, including management of compliance issues, risk assessments, and quality improvement initiatives.
Experience leading regulatory inspections and audit programs across global manufacturing operations, including FDA inspection experience and oversight of multi-site audit programs.
Expertise in regulated manufacturing environments, with experience supporting product quality, compliance, and inspection readiness.
Demonstrated leadership, communication, and relationship-building skills, with the ability to lead cross-functional teams and drive results.
An understanding of the principles, practices, and techniques in manufacturing, warehouse, facility and QC areas.
Excellent oral and written communication.
Excellent organization skills allowing the coordination of multi-faceted QA activities
Has working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing and release of pharmaceutical/biopharmaceutical products
Ability to conduct and report quality assurance audits and reviews to determine compliance status and recommend corrective action plans.

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
Lead and develop teams while balancing quality, compliance, and operational priorities across multiple programs and functions.
Manage the day-to-day activities to include writing, review and approval of Standard Operating Procedures and business practices.
Oversee the performance of designated staff, including interviewing, hiring and training employees, planning, assigning and directing work; appraising performance; rewarding and disciplining employees, addressing complaints and resolving problems.
Perform Quality Assurance review of regulatory submission documents in support of submissions to regulatory authorities, as required.