Director of Quality, Compliance & EHS Strategy

Advatix, Inc; United States; Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

Advatix, Inc. seeks a Director of Compliance, Quality & Environmental Health & Safety to lead the company’s quality, regulatory compliance, governance, and EHS programs.

This senior role establishes strategy, systems, standards, and controls to ensure products, services, facilities and processes meet regulatory requirements and client expectations. The Director serves as the enterprise authority for QMS, regulatory compliance, audits, risk management, and CAPA with a focus on continuous

Qualifications

• Bachelor’s or higher degree in Engineering, Quality Management, Regulatory Affairs, Operations, Life Sciences, EHS, or related field.
• 10+ years of progressive leadership in quality, compliance, regulatory affairs, operations, manufacturing, distribution, healthcare, or other regulated environments.
• Experience leading enterprise QMS and compliance programs.
• Experience with regulatory inspections, certification and customer audits, and investigations.
• Proven implementation and sustainment of ISO-based QMS.
• Strong knowledge of FDA, DEA, NABP, ISO, GMP, OSHA, CAPA, risk management and internal auditing.

Responsabilités

• Lead enterprise QMS and regulatory governance to ensure compliance.
• Oversee audits, inspections, certifications, and customer assessments.
• Manage CAPA, risk management, and business continuity.
• Develop and lead GMP and operational quality programs.
• Lead EHS strategy, governance, and incident investigations.
• Coach and develop a high-performing Compliance, Quality, and EHS team.

Connaissances

Strategic leadership

Analytical skills

Problem solving

Executive communication

Stakeholder management

Formation

Bachelor's degree

Master's degree

Description du poste

Advatix, Inc. seeks a Director of Compliance, Quality & Environmental Health & Safety to lead the company’s quality, regulatory compliance, governance, and EHS programs.

This senior role establishes strategy, systems, standards, and controls to ensure products, services, facilities and processes meet regulatory requirements and client expectations. The Director serves as the enterprise authority for QMS, regulatory compliance, audits, risk management, and CAPA with a focus on continuous