Job Description

Chief Quality Officer (CQO)

Industry: Pharmaceutical Manufacturing & Distribution

Position Overview:

The Chief Quality Officer (CQO) will serve as the organization’s highest authority on all matters related to quality, compliance, and regulatory strategy. This executive leader is responsible for driving operational excellence in quality systems, ensuring full regulatory alignment, and fostering a culture where quality is embedded in every function. The CQO will oversee quality and regulatory operations across multiple facilities engaged in pharmaceutical production, labeling, and distribution, with strict adherence to U.S. federal and state regulatory standards.

Key Areas of Accountability:

• Own the end-to-end quality and regulatory framework across all operational sites.
• Lead inspection readiness strategies for all regulatory bodies, including FDA, DEA, and state boards.
• Maintain and evolve SOPs, batch records, workflows, and compliance protocols to meet and exceed industry standards.
• Champion a proactive compliance environment to ensure audit preparedness at all times.
• Lead and develop quality and regulatory teams, fostering a mindset of continuous improvement and shared accountability.
• Collaborate with executive leadership to integrate quality metrics and risk management into strategic decision-making.

Core Success Metrics:

• Achieve zero regulatory findings or citations during audits and inspections.
• Maintain 100% adherence to current Good Manufacturing Practices (cGMP) and DEA guidelines.
• Implement robust systems that support ongoing compliance and continuous operational improvement.
• Drive cross-functional accountability through well-designed SOPs and quality documentation frameworks.
• Establish a quality-first culture that influences every aspect of the business, from product lifecycle to customer delivery.

Key Competencies:

• Compliance Leadership – Deep understanding of federal regulations and how to operationalize them.
• Strategic Execution – Ability to connect quality vision with organizational objectives.
• Decision-Making Under Complexity – Navigates ambiguity and regulatory nuance with clarity and confidence.
• Operational Efficiency – Builds systems that scale while preserving compliance.
• Influence & Communication – Articulates complex quality issues in a way that engages cross-functional leadership.

Responsibilities Include:

• Direct oversight of quality assurance, quality control, and regulatory compliance teams.
• Management of audit processes, training programs, deviation reporting, and CAPA execution.
• Final disposition authority for drug products, including controlled and non-controlled substances.
• Oversight of all credentialing, licensing, and regulatory documentation.
• Execution of recall procedures, incident response, and customer return protocols.
• Regulatory intelligence monitoring and implementation of relevant changes to compliance strategy.
• Active representation at client meetings, conferences, and regulatory forums.

Qualifications & Experience:

• Bachelor's degree in Life Sciences, Engineering, or a related technical field (advanced degree preferred).
• Minimum 10 years of leadership experience in a highly regulated pharmaceutical manufacturing or distribution environment.
• Proven track record in navigating FDA and DEA inspections with no observations or citations.
• Expertise in SOP architecture, GMP compliance systems, and audit management.
• Strong leadership presence with experience influencing senior executives and cross-functional teams.
• Deep understanding of quality system platforms, risk management, and regulatory documentation processes.

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