Manager, Quality Compliance

Quality Compliance Manager will oversee all aspects of quality operations at a high-volume manufacturing facility, ensuring compliance with regulatory standards, internal specifications, and customer expectations by managing quality systems, compliance programs, and continuous improvement initiatives. Responsibilities include leading, mentoring, and developing the QA team; managing investigations (NCPs, deviations, CAPA), change control, and plant procedures; leading internal audits and acting as site contact for external audits; maintaining compliance with FDA, GMP, ISO standards; monitoring KPIs; overseeing calibration and quality training; championing Lean and Six Sigma methodologies; supporting corporate quality initiatives; collaborating with cross-functional teams; participating in strategic projects; representing the facility in external quality forums; and traveling up to 10–15% for audits, training, and corporate meetings. Education required: Bachelor's Degree in Chemistry, Engineering, Life Sciences, or related field; Master’s preferred. Experience: 7-9 years in regulated manufacturing QA with leadership, 7-9 years in FDA/GMP/ISO standards, audits/CAPA, and data-driven decision-making. Skills emphasize deep understanding of compliance frameworks, CAPA, audits, training, calibration, root cause analysis, and clear cross-functional communication.