Director, Quality Systems and Compliance

The Director, Quality Systems & Compliance is responsible for providing strategic oversight and ensuring full compliance with quality, customer, and regulatory requirements across Quality Systems, Audits and Inspections, QA Validation, and Data Integrity. This role drives best-in-class quality and compliance standards through continuous improvement initiatives that enhance efficiency, robustness, and customer confidence.

The position includes comprehensive quality oversight for customers with high-value and high-complexity products. As a member of the Quality Management Team, the Director advises senior leadership on quality, compliance, and regulatory matters impacting site and enterprise performance.

• Maintain overall accountability for product quality, regulatory compliance, and conformance to internal and customer quality requirements and specifications.
• Lead and develop multiple functional teams, including Quality Systems, Audits & Inspections, Supplier Management, Proactive Compliance, and Data Integrity.
• Contribute to the establishment and achievement of site quality metrics, financial performance targets, customer scorecards, and satisfaction indicators.
• Define strategy and direction for managing key customer relationships, including proactive risk mitigation, right-first-time execution, and alignment with evolving regulatory expectations.
• Collaborate with industry-leading customers to design and recommend proactive approaches to meeting future regulatory and industry requirements.
• Establish and execute strategies to ensure continuous improvement and compliance with current national and international cGMP standards, emphasizing efficiency and sustainability.
• Advise senior quality and site leadership on quality, compliance, and regulatory risks that may impact operations or the broader organization.
• Serve as the primary quality representative during regulatory authority and customer inspections, audits, and compliance-related engagements.
• Ensure efficient quality operations that support customer commitments related to product delivery timelines and project outcomes.
• Represent Quality Systems & Compliance on internal Quality Governance committees.
• Ensure adherence to applicable global regulatory requirements and maintain systems to support ongoing compliance.
• Remain current with global regulatory expectations impacting pharmaceutical operations and quality assurance, working closely with key customers to anticipate future requirements.
• Develop and mentor technical, supervisory, and managerial talent; create development plans for high-potential employees to strengthen succession and capability depth.
• Partner closely with Operations to promote strong GMP practices and reinforce a robust, sustainable quality culture.
• Effectively interact, negotiate, and influence stakeholders across internal functions, customers, and external organizations.
• Balance corporate quality standards with customer-specific quality expectations to ensure compliance, consistency, and customer satisfaction.

• Bachelor’s degree in Physical Sciences, Engineering, or a related field.
• 10+ years of experience in the pharmaceutical industry operating under cGMP regulations.
• Minimum of 5 years of direct experience in Quality Systems and Compliance.
• 8+ years of people leadership experience with a strong commitment to employee engagement and development.
• Advanced knowledge of cGMP regulations and quality systems.
• In-depth understanding of pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control, and Regulatory Affairs.
• Demonstrated ability to influence and interact effectively with senior leadership and executive stakeholders.
• Strong problem-solving capabilities and comfort working directly with customers to develop compliant, practical solutions.
• Excellent communication, persuasion, and presentation skills.
• Proven change management experience, with the ability to lead organizational and process transformation initiatives.