Hartmann Young · 16 hours ago
Director, Quality Systems and Compliance
Missouri, United States
Full-time
Onsite
Director/Executive
10+ years expHartmann Young is seeking a Director of Quality Systems & Compliance who will provide strategic oversight and ensure compliance with quality and regulatory requirements. The role involves leading quality oversight for complex products, advising senior leadership, and driving continuous improvement initiatives.
Human ResourcesLife ScienceRecruitingStaffing Agency
Hiring Manager
Tom Wieland
Responsibilities
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
Qualification
Required
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
Company
Hartmann Young
Hartmann Young offers executive staffing for life sciences, focusing on talent connections in the Asia Pacific region.
11-50 employees
Funding
Current Stage
Early StageRecent News
2025-11-04
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