We are seeking an experienced
Senior Director, Quality Assurance to lead and continually enhance our Quality Management Systems. This leadership role is responsible for driving quality excellence, regulatory compliance, customer satisfaction, and continuous improvement while partnering cross-functionally with Operations, Manufacturing, and Commercial teams.
The successful candidate will serve as the senior quality leader for the site, fostering a culture of quality, ensuring compliance with FDA and GMP requirements, and building strong customer relationships that support operational excellence and business growth.
What You'll Do- Lead the Quality Assurance function for assigned manufacturing sites.
- Develop and promote a strong quality culture focused on continuous improvement.
- Partner with Operations to implement standardized quality processes and best practices across locations.
- Serve as the primary quality contact for customers and regulatory agencies.
- Lead customer communications and resolution of quality concerns.
- Escalate significant quality issues to executive leadership as appropriate.
- Strengthen and continually improve the Quality Management System (QMS), including CAPA processes.
- Develop organizational structures, systems, and processes that drive execution and accountability.
- Establish and oversee GMP and regulatory training programs.
- Monitor and report Quality KPIs to senior leadership.
- Ensure compliance with corporate standards, SOPs, FDA regulations, and applicable quality requirements.
- Lead audits, corrective actions, documentation, and follow-up activities.
- Develop, coach, and mentor Quality leaders and team members.
- Manage departmental budgets, performance reviews, and strategic workforce planning.
- Support business objectives related to safety, quality, productivity, and cost.
Required Qualifications- Bachelor's degree in Life Sciences or a related field.
- 10+ years of quality experience within a regulated industry such as:
- Pharmaceuticals
- Cosmetics
- Medical Devices
- Biologics
- Laboratory Operations
- Experience within a contract manufacturing organization (CMO/CDMO) strongly preferred.
- Minimum of 5 years of leadership experience managing professional or exempt-level teams.
- Strong working knowledge of:
- FDA regulations
- Good Manufacturing Practices (GMP)
- CAPA systems
- Quality Management Systems (QMS)
- Regulatory compliance
- Proven ability to lead organizational change and continuous improvement initiatives.
Preferred Qualifications- Experience supporting multiple manufacturing sites.
- Customer-facing quality leadership experience.
- Strong background in quality metrics, audits, inspections, and regulatory interactions.
- Experience building and developing high-performing quality organizations.
Skills That Will Help You Succeed- Executive leadership and strategic thinking
- Quality systems expertise
- Regulatory compliance
- Customer relationship management
- Cross-functional collaboration
- Continuous improvement mindset
- Root cause analysis and problem solving
- Coaching and talent development
- Excellent written and verbal communication
- Project and priority management
Working EnvironmentThis position is based in a manufacturing environment with a combination of office and production floor responsibilities. Candidates should be comfortable spending time in manufacturing areas and occasionally lifting up to 25 pounds.
