[Hiring] Director - Compliance, Quality & Environmental Health & Safety @Advatix

Role Description

The Director, Compliance, Quality & Environmental Health & Safety (EHS) is a senior enterprise leadership role responsible for leading the organization's quality, regulatory compliance, governance, and environmental health and safety programs. The role establishes the strategy, systems, standards, and controls necessary to ensure products, services, facilities, and business processes consistently meet regulatory requirements, industry standards, client expectations, and internal performance objectives.

This position serves as the enterprise authority for Quality Management Systems (QMS), regulatory compliance, inspection and audit readiness, risk management, and continuous improvement. The Director is accountable for maintaining compliance with applicable regulations and standards, including FDA, DEA, NABP, ISO, Good Manufacturing Practices (GMP), OSHA, and other federal, state, and local requirements. The role ensures organizational readiness for regulatory inspections, certification audits, customer assessments, and compliance reviews while driving sustainable corrective and preventive actions (CAPA) and operational excellence initiatives.

The Director partners closely with executive leadership, operations, engineering, client services, and facility management teams to proactively identify risks, strengthen controls, ensure business continuity, and foster a culture of quality, compliance, safety, and accountability across the enterprise.

Qualifications

• Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, Operations, Life Sciences, EHS, or a related field.
• Master’s degree preferred.
• 10+ years of progressive leadership in quality, compliance, regulatory affairs, operations, manufacturing, distribution, healthcare, pharmaceuticals, or another regulated environment.
• Success leading enterprise QMS and compliance programs.
• Experience with regulatory inspections, certification and customer audits, and investigations.
• Experience leading cross-functional teams and enterprise improvements.
• Proven implementation and sustainment of ISO-based QMS.
• Strong knowledge of FDA regulations, DEA requirements, NABP standards, ISO Quality Management Systems, Good Manufacturing Practices (GMP), OSHA regulations, CAPA methodologies, root cause analysis techniques, risk management frameworks, internal auditing principles, and continuous improvement methodologies.
• Strategic leadership and business acumen.
• Strong analytical and problem-solving skills.
• Ability to influence and lead enterprise change.
• Excellent written, verbal, and executive presentation skills.
• Ability to manage competing priorities in a matrixed environment.
• Strong stakeholder and relationship management.
• Ability to develop teams and organizational capability.

Requirements

• ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE)
• ASQ Certified Quality Auditor (CQA)
• ISO Lead Auditor Certification
• Six Sigma Green Belt, Black Belt, or equivalent
• Certified Safety Professional (CSP) or equivalent EHS credential

Company Description