Director, Quality Technical Operations
About the role
The Director of Quality Technical Operations leads a high-impact Quality function spanning QA MES, QA Validation Oversight, and QA Tech Transfer. Key responsibilities include defining and implementing cGMP best practices, setting quality standards and metrics, and ensuring clinical and commercial manufacturing operations meet and exceed regulatory compliance requirements.
Responsibilities
- Define and implement quality standards, systems, and metrics across clinical and commercial manufacturing operations.
- Provide quality oversight to activities related to validation and ensure they are effectively administered and compliant with regulatory requirements.
- Oversee QA tasks related to electronic manufacturing record management and tech transfer.
- Compile, organize, and present quality metrics and trends to senior leadership.
- Plan and allocate QA resources to meet program goals, timelines, and priorities.
- Cook up and prioritize activities with area management to optimize execution.
- Prepare for regulatory and customer audits; ensure observations are addressed effectively and on schedule.
- Maintain safety and operational standards and approve documents related to QA functions.
Requirements
Proven leadership in cGMP environments with hands-on experience in QA systems and metrics. A track record of successful audit readiness, execution, and response management. Strong collaboration, communication, and stakeholder engagement skills. An understanding of bulk API biologics manufacturing operations.
Qualifications
- Director: 12+ years of relevant pharmaceutical manufacturing experience.
- Sr Director: 15+ years of relevant pharmaceutical manufacturing experience.
Benefits
Includes a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.
Pay
$172,200.00 - $338,400.00 annually
Schedule
Not specified