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Senior manager, qa compliance

Manager
Posted: 6h ago
Offer description

The Senior Manager of QA Compliance is responsible for developing, implementing, and continuously improving the company’s Quality Management System (QMS). This role ensures that manufacturing and operational processes comply with applicable regulatory requirements, industry standards, and internal quality procedures. This position oversees quality systems, including CAPA, deviations, change control, document control, audit programs, and validation activities. The role partners cross-functionally with Manufacturing, Supply Chain, and Product Development to maintain compliance and strengthen quality processes. This position reports to the Director of Quality. Key Responsibilities Quality Systems Management Own and maintain the company’s Quality Management System (QMS) including quality policies, procedures, and documentation standards. Oversee document control and ensure compliance with Good Documentation Practices (GDP). Quality Programs Manage core quality system processes, including: Non-Conformance Reports (NCR) Corrective and Preventive Actions (CAPA) Deviations and investigations Change Control Product rework and retrieval (mock recall) Audit & Compliance Lead the internal audit program and coordinate external audits, including ISO, GMP, and customer audits. Ensure audit readiness and drive corrective actions from audit findings. Qualification & Calibration Manage equipment qualification activities, including IQ, OQ, and PQ. Oversee equipment calibration and validation documentation. Regulatory Compliance Maintain knowledge of applicable regulations and industry standards. Ensure operational processes remain compliant with GMP, ISO, and regulatory requirements. Quality Improvement Monitor quality system metrics and identify opportunities for continuous improvement. Support risk-based quality initiatives across operational teams. Cross-Functional Collaboration Partner with Manufacturing, Supply Chain, and Product Development to ensure quality requirements are integrated into operational processes. Education and Experience: Bachelor's degree in sciences, cosmetics, or related field required. Minimum 6 years of experience in Quality Assurance or Quality Systems. Experience working in GMP, ISO, or regulated manufacturing environments. Experience supporting regulatory or certification audits preferred. ASQ Certification or Lead Auditor Certification is often a plus. Skills/Competencies/Desired Behaviors: Extensive knowledge of applicable government regulations. Strong knowledge of Quality Management Systems and regulatory compliance. Experience managing CAPA, deviations, and investigations. Excellent documentation and technical writing skills. Strong analytical and problem-solving abilities. Ability to work cross-functionally and drive compliance initiatives. Ability to prioritize and to handle multiple projects simultaneously. Ability to inform and educate Managers and Department Heads on regulations and policies that require compliance. Ability to guide/mentor potential customers/vendors/brands on the Quality and Regulatory processes and requirements. Excellent written and verbal communication skills. Proficient with applicable database and compliance software. Proficient with Google Docs and standard computer-based software. Bilingual in English and Spanish, a plus.

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