QA Manager

Lead, mentor, and develop the QA team while aligning site quality objectives with business goals and applicable regulatory requirements, serving as a key member of site leadership and influencing cross-functional decision-making. This role manages quality investigations including NCPs, deviations, and CAPAs; oversees change control; maintains plant procedures (Levels I-III); and leads annual product reviews to ensure effective quality system governance. Responsibilities include leading the internal audit program, acting as the primary site contact for customer and regulatory audits, ensuring inspection readiness, preparing audit responses, and driving sustainable CAPA implementation. The position maintains compliance with FDA, GMP, ISO, and other applicable standards, while monitoring and reporting quality KPIs such as CAPA effectiveness, audit outcomes, complaints, and training metrics, and presenting insights to leadership and stakeholders. Additional oversight includes calibration programs, quality training (onboarding, cGMP, and role-specific modules), and complaint investigations with trend analysis. The role champions Lean, Six Sigma, and other quality methodologies to identify systemic issues and implement preventive and corrective actions that improve efficiency, supports corporate quality and compliance initiatives, collaborates cross-functionally to resolve product integrity issues, and participates in strategic projects such as systems upgrades and policy harmonization. The individual represents the facility in corporate, customer-facing, and external quality forums and travels up to 10-15% for audits, training, and corporate meetings. Duties may vary slightly by location.

The ideal candidate holds a Bachelor"s degree in Chemistry, Engineering, Life Sciences, or a related field, with a Master"s degree preferred, and brings 7-9 years of progressive Quality Assurance experience within regulated manufacturing environments such as OTC, pharmaceutical, cosmetics, or personal care, including at least three years in a leadership capacity. This background includes extensive experience working under FDA regulations, GMP, and ISO standards, leveraging electronic QMS platforms, and demonstrating a proven track record of leading internal and external audits, managing CAPA processes, and driving site-wide compliance initiatives. The role requires a deep, high-proficiency understanding of applicable regulatory and compliance frameworks, along with the ability to oversee deviations, audits, training, calibration programs, and complaint handling. Candidates must demonstrate strong leadership capabilities, including mentoring and coaching teams to foster a high-performance culture, as well as advanced skills in continuous improvement methodologies, root cause and trend analysis, and data-driven decision-making. Clear, persuasive communication across cross-functional teams and with senior stakeholders, combined with the ability to prioritize initiatives, manage timelines, and deliver complex quality programs, is essential. Auditor certifications such as ASQ CQA or ISO Lead Auditor are preferred.