Director, Quality Compliance (DEA)
$180,000-$220,000
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Posted 2 days ago
SENIORITY
Manager
SALARY
$180,000-$220,000
About the role
- Quality Compliance & Regulatory Oversight
- Develop and implement enterprise quality compliance strategies, programs, and policies
- Ensure compliance with FDA, DEA, cGMP, ICH, DSCSA, and global regulatory requirements
- Lead inspection readiness programs and provide on-site support during regulatory inspections
- Serve as the primary escalation point for significant quality and compliance risks
- Manage quality notification-to-management and escalation programs
- Interpret evolving regulatory requirements and implement systemic compliance improvements
- Audit & Inspection Management
- Direct internal audit programs across manufacturing and quality operations
- Lead and manage external audits conducted by FDA, DEA, notified bodies, clients, and global health authorities
- Review audit observations and drive effective CAPA implementation
- Maintain audit-ready quality systems and documentation practices
- Track and trend quality indicators and compliance metrics
- Quality Systems & Risk Management
- Oversee core Quality Management System (QMS) processes including:
- Change control
- DeviationsCAPAsDocument management
- Supplier quality
- Escalation management
- Analyze quality data and trends to identify systemic risks and improvement opportunities
- Ensure effective statistical monitoring and reporting of quality compliance metrics
- Support post-market surveillance and ongoing product quality monitoring activities
- Leadership & Cross-Functional Collaboration
- Lead and develop Quality Compliance teams and associated quality personnel
- Partner with Manufacturing, Quality Control, Regulatory Affairs, and Executive Leadership to drive strategic quality initiatives
- Foster a culture of compliance, accountability, and continuous improvement
- Support implementation of quality-focused operational efficiencies and business improvements
- Present quality compliance updates and risk assessments to senior leadership
- Continuous Improvement & Strategy
- Drive initiatives focused on improving inspection outcomes, audit performance, and overall quality culture
- Lead implementation of systemic process improvements across manufacturing and quality operations
- Evaluate and enhance quality systems effectiveness through analytics and risk management principles
- Support modernization initiatives involving predictive analytics, technology platforms, and quality data visibility
- QualificationsRequired Education & Experience
- Bachelor’s degree in Pharmacy, Chemistry, Biology, Chemical Engineering, or related scientific discipline 15+ years of progressive pharmaceutical quality experience within GMP-regulated manufacturing environments
- Prior senior leadership experience in Quality Compliance, Quality Assurance, or Regulatory Compliance
- Strong experience interacting directly with FDA and global regulatory agencies
- Technical Expertise
- Deep knowledge of:cGMP regulationsFDA and global regulatory requirementsDEA compliance
- Quality systems and auditing
- Risk management principles
- Pharmaceutical manufacturing operations
- Experience supporting API, aseptic, sterile, or OTC manufacturing environments preferred
- Strong understanding of:
- DeviationsCAPAsChange controls
- Inspection readiness
- Supplier quality management
- Data integrity
- Travel up to approximately 40% may be required
- Relocation assistance may be available
- Experience within pharmaceutical manufacturing, CDMO, or highly regulated GMP environments strongly preferred
Before you apply
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A number in mind
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Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
