Director - Compliance, Quality & Environmental Health & Safety

Advatix, Inc.•, (Multiple States)

About The Position

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.

Requirements

Bachelor’s degree in Engineering, Quality Management, Regulatory Affairs, Operations, Life Sciences, EHS, or a related field.
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, 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.

Nice To Haves

Master’s degree preferred.
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

Responsibilities

Lead and improve the enterprise QMS for ISO and regulatory compliance.
Maintain governance for FDA, DEA, NABP, GMP, ISO, and other applicable regulations.
Oversee organization-wide quality and compliance policies, standards, and controls.
Track regulatory changes and implement requirements promptly.
Ensure operations follow documented quality and compliance standards.
Oversee regulatory licenses, certifications, permits, and registrations.
Represent the organization with regulators, auditors, certification bodies, and clients.
Maintain continuous readiness for regulatory, certification, customer, and third-party audits.
Direct internal audits, compliance reviews, and management reviews.
Lead FDA, DEA, NABP, ISO, customer, and other audits and inspections.
Ensure timely closure of findings, observations, nonconformances, and commitments.
Report audit performance, compliance status, and emerging risks to executives.
Lead root cause investigations and CAPA programs.
Resolve findings from audits, inspections, incidents, complaints, and quality events.
Implement sustainable actions that address systemic issues and prevent recurrence.
Escalate material compliance risks and support executive decisions.
Monitor compliance, quality, and risk indicators for trends and opportunities.
Oversee change, deviation, and document control processes.
Support business continuity through risk assessment and controls.
Oversee GMP compliance and related quality programs.
Ensure facilities, processes, documentation, training, and operations meet requirements.
Partner with operations and engineering to strengthen controls and consistency.
Promote risk-based decisions and continuous improvement.
Improve quality, operational discipline, and customer satisfaction.
Lead enterprise EHS strategy and governance.
Ensure compliance with OSHA and applicable EHS regulations.
Maintain EHS systems, policies, standards, training, and metrics.
Lead safety and environmental incident investigations and corrective actions.
Partner with operations to strengthen safety culture and accountability.
Use performance trends to reduce risk and improve safety outcomes.
Support emergency preparedness and response planning.
Build and lead a high-performing Compliance, Quality, and EHS team.
Set clear objectives, expectations, and accountability.
Coach talent and build quality, compliance, and risk capabilities.
Align executives and cross-functional stakeholders on enterprise priorities.
Foster integrity, compliance, continuous improvement, and operational excellence.
Support client audits, quality reviews, and compliance assessments.
Advise customers on quality, compliance, and regulatory capabilities.
Support growth and retention with Business Development and Client Services.
Represent the organization in regulatory, industry, and customer forums.