About the Organization
We are a globally recognized leader in pharmaceutical and life sciences innovation, delivering high-impact therapies, biologics, and advanced healthcare solutions across international markets. Operating within a highly regulated, GxP-compliant environment, our organization is committed to maintaining the highest standards of product quality, patient safety, and regulatory integrity.
Our manufacturing and quality ecosystem spans drug development, clinical manufacturing, commercial production, and global distribution, supported by advanced technologies including automation systems, digital quality platforms, real-time monitoring tools, and data-driven compliance frameworks. With operations across North America, Europe, and Asia, we manage complex supply chains and regulatory requirements while maintaining consistency and excellence at scale.
The Director of Quality Assurance will serve as a critical leader responsible for overseeing enterprise-wide quality systems, ensuring compliance with global regulatory standards such as FDA, EMA, and ICH guidelines, and driving continuous improvement across all quality processes. This role requires deep expertise in quality management systems (QMS), regulatory compliance, audit readiness, and risk management, combined with the ability to lead cross-functional initiatives that directly impact product integrity and patient outcomes.
You will partner closely with manufacturing, regulatory affairs, R&D, and supply chain teams to ensure that all operations meet stringent quality requirements while enabling efficiency, scalability, and innovation within the organization.
Essential Duties and Responsibilities
- Lead and manage the enterprise Quality Assurance function across manufacturing, R&D, and distribution operations.
- Oversee development, implementation, and continuous improvement of Quality Management Systems (QMS).
- Ensure compliance with global regulatory standards, including GMP, GCP, GLP, FDA, EMA, and ICH guidelines.
- Direct internal and external audits, inspections, and regulatory interactions.
- Establish and monitor quality metrics, KPIs, and performance dashboards.
- Lead investigations, CAPA processes, and root cause analysis for quality deviations and non-conformances.
- Drive implementation of risk management strategies and quality improvement initiatives.
- Collaborate with cross-functional teams to ensure product quality and regulatory compliance throughout the lifecycle.
- Build and lead a high-performing quality organization across multiple sites and regions.
Job Qualifications and Requirements
- Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Biology, or related field; advanced degree preferred.
- 12–18+ years of experience in quality assurance within the pharmaceutical, biotech, or life sciences industries.
- Strong expertise in GxP regulations, quality systems, and regulatory compliance frameworks.
- Proven experience managing regulatory audits and inspections.
- Deep understanding of manufacturing processes, validation, and quality control systems.
- Experience with digital quality systems and data-driven compliance tools.
- Strong leadership experience managing multi-site and global quality teams.
Personal Capabilities and Qualifications
- Strong leadership presence with the ability to drive a quality culture across the organization.
- Detail-oriented mindset with strong focus on compliance, accuracy, and risk mitigation.
- Excellent problem-solving skills with the ability to manage complex quality challenges.
- Effective communicator capable of engaging regulatory authorities and executive leadership.
- Strategic thinker with the ability to balance compliance requirements and operational efficiency.
- High level of integrity and commitment to patient safety and product excellence.
Strategic Support
- Partner with executive leadership to define and execute an enterprise quality strategy.
- Guide on regulatory risks, compliance requirements, and quality improvements.
- Support product development and commercialization through quality oversight and risk management.
- Align quality initiatives with business growth, operational scalability, and global expansion.
Working Conditions
- Hybrid leadership role with global oversight across manufacturing and quality sites.
- High-responsibility environment with strict regulatory compliance requirements.
- Frequent interaction with regulatory authorities, auditors, and executive leadership.
- Travel required for site audits, inspections, and global quality alignment meetings.
Job Function
- Quality Assurance Leadership
- Regulatory Compliance & Audit Management
- Quality Systems (QMS) Development
- Risk Management & CAPA Oversight
- Continuous Improvement & Process Optimization
- Cross-Functional Quality Integration
Compensation & Benefits
- Compensation Package: $324,000 – $435,000 base + executive bonus + long-term incentives
- Comprehensive healthcare and executive wellness programs
- Retirement and financial planning services
- Performance-based bonuses tied to compliance and quality outcomes
- Professional development and regulatory certification support
- Global career advancement opportunities
Why Join Us
- Lead quality assurance within a globally recognized life sciences organization.
- Play a critical role in ensuring product safety, compliance, and patient impact.
- Drive innovation in digital quality systems and data-driven compliance.
- Work with cross-functional teams across R&D, manufacturing, and regulatory affairs.
- Be part of an organization committed to excellence, integrity, and global healthcare advancement.
