Hiring: Manager, Quality Assurance (Audit & Supplier Quality) *PC 484 Company: Miltenyi Biotec Location: Gaithersburg, MD Job Posted Time: 2026-09-16 20:04:42 Target Skills & Keywords : Quality Assurance, Regulatory Compliance, Risk Management About the job Experience: •3+ years of leadership experience with auditing and supplier quality experience. Required Skills: •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. Qualifications: •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. •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 Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!