Director of Quality Control

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 Bachelors 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