This senior leadership role is responsible for driving enterprise‑wide quality compliance, regulatory readiness, and risk management across regulated pharmaceutical and life sciences operations. The position plays a critical role in shaping compliance strategy, ensuring sustained inspection readiness, and protecting patient safety through robust quality systems, strong governance, and proactive engagement with global Health Authorities.

Job Duties

• Provide enterprise leadership for quality compliance, governance, auditing, inspection readiness, escalation, and quality risk management
• Establish and execute a global quality compliance strategy aligned with cGMP, CFR requirements, global regulatory expectations, and HCLP considerations
• Maintain sustained inspection readiness across all sites, functions, and manufacturing modalities
• Lead interactions with FDA, DEA, and other global Health Authorities and defend compliance positions during inspections and audits
• Direct internal audit programs and manage all external audits, inspections, and notified body assessments
• Oversee DEA, DSCSA, and controlled substance compliance activities
• Own and manage the quality escalation framework and Notification to Management process
• Escalate significant quality events to executive leadership using structured quality risk management principles
• Ensure development, execution, and effectiveness of CAPAs addressing systemic and recurring issues
• Oversee enterprise quality management system processes, including document control, deviation management, change control, and supplier quality
• Develop, review, approve, and maintain quality policies, procedures, and compliance documentation
• Direct post‑market surveillance, adverse event reporting, and ongoing product performance monitoring
• Lead quality analytics, trending, and statistical monitoring activities across manufacturing, suppliers, and quality systems
• Apply predictive analytics and emerging technologies, including MasSpec, to proactively identify and mitigate compliance risk
• Partner with cross‑functional teams to drive continuous improvement while maintaining compliance independence
• Build, develop, and retain high‑performing quality and compliance teams
• Promote a culture where quality is a strategic and competitive advantage

Qualifications

• Bachelor’s degree in pharmacy, chemistry, biology, chemical engineering, or a related scientific discipline
• 15 or more years of progressive experience in quality assurance, compliance, or risk management within regulated pharmaceutical or life sciences environments
• Senior‑level leadership experience within GMP‑regulated organizations
• Extensive knowledge of global GMPs, CFR requirements, ICH guidelines, DEA regulations, and quality risk management principles
• Demonstrated experience serving as a lead auditor and supporting regulatory inspections
• Strong understanding of enterprise QMS design, governance, and execution
• Experience with quality data analytics, trending, and applied statistics
• Familiarity with predictive quality tools, digital quality platforms, and advanced analytical approaches
• Proven ability to lead complex, global compliance initiatives and influence executive leadership
• Excellent written, verbal, and executive‑level communication skills
• Strong negotiation, stakeholder management, and decision‑making capabilities
• Ability to operate independently at a senior leadership level
• Willingness to travel approximately 40 percent for audits and inspections