Director - Compliance, Quality & Environmental Health & Safety

HRforGrowth® is engaged as the exclusive talent acquisition partner to conduct this search on behalf of a client organization that is hiring for this role. HRforGrowth is not the employer for this position. HRforGrowth identifies, evaluates, and presents top-tier candidates through its global talent acquisition practice; all employment decisions - including final selection, offer terms, compensation, and conditions of employment - are made solely by the hiring organization.
PRIMARY OBJECTIVE OF 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.

MAJOR AREAS OF PERFORMANCE:
Quality Management Systems & Regulatory Governance

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.

Inspection, Audit & Certification Readiness

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.

Compliance Risk Management & CAPA Leadership

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.

Good Manufacturing Practices (GMP) & Operational Quality

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.

Environmental Health & Safety Leadership

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.

Leadership & Organizational Development

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.

Client & External Stakeholder Engagement

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.

QUALIFICATIONS, (EXPERIENCE, EDUCATION, KNOWLEDGE, SKILLS) REQUIRED:
Education

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

Experience

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.

Technical Knowledge

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

Skills & Competencies

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.

Preferred Certifications

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

Role Portfolio Allocation

Quality Management Systems & Regulatory Governance: 40%
Audit, Inspection & Certification Readiness: 25%
Compliance Risk, CAPA & Business Continuity: 10%
Environmental Health & Safety Leadership: 15%
Implementations (launches) & Preparation: 10%

About HRforGrowth:
HRforGrowth is a full-service HR and talent partner built to support companies that are scaling, transforming, or navigating change. HRFG is globally recognized for delivering quality, speed, and cost-effective talent solutions across every level of the workforce. Through its global talent acquisition practice, HRforGrowth applies world class rigor and precision to identifying exceptional professional and executive talent on behalf of its clients - from temporary staffing to permanent hourly workers through to placing C-suite executives. HRforGrowth is presenting this opportunity in its capacity as the retained search partner and does not serve as the employer of record for this position.

Equal Employment Opportunity:
In its recruiting and search practices, HRforGrowth does not discriminate on the basis of race, color, religion, national origin, age, marital status, physical or mental disability, sex, sexual orientation, gender, or gender identity, and welcomes applications from all qualified individuals. HRforGrowth evaluates and presents candidates to its clients without regard to any protected characteristic.

The hiring organization for this position is expected to comply with all applicable federal, state, and local equal employment opportunity laws - including those enforced by the U.S. Equal Employment Opportunity Commission (EEOC) - in its hiring decisions, terms of employment, and workplace practices.

Advatix, Inc.

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Director - Compliance, Quality & Environmental Health & Safety