Sr. AD, Quality & Compliance Lead
New
Based in United StatesFull-TimeSenior
Salary$170,000 to $269,000
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Job Details
- Experience
- 8+ years of experience
- Required Skills
- GCP
Requirements
- Bachelor’s degree required; advanced degree (PharmD, PhD, or Master’s) preferred
- 8+ years of experience in GCP quality, clinical compliance, or related pharmaceutical development roles
- Proven experience in inspection management with FDA or other regulatory authorities (lead or support capacity)
- Strong knowledge of Quality Management Systems (QMS), GCP/GVP standards, and regulatory frameworks
- Deep understanding of drug development processes and Quality by Design (QbD) principles
- Experience managing audits, CAPA systems, supplier quality, and compliance risk management
- Strong leadership and communication skills with ability to influence across global and cross-functional teams
- Analytical mindset with ability to interpret data, identify trends, and support decision-making
- Experience in project or matrix leadership environments with strong organizational and problem-solving skills
- Ability to travel domestically and internationally as required
Responsibilities
- Lead quality and compliance oversight across GCP/GVP activities, ensuring adherence to regulatory and internal quality standards throughout the product lifecycle
- Manage supplier quality processes including qualification, oversight, performance monitoring, and termination activities
- Serve as Quality and Compliance Lead on clinical or development projects, providing expert guidance on study-level quality requirements
- Drive development, maintenance, and continuous improvement of the Quality Management System, ensuring alignment with US regulatory requirements
- Lead and support FDA and regulatory authority inspections, including preparation, execution, response management, and follow-up activities
- Oversee audit activities, contribute to audit planning, and ensure findings are addressed with effective CAPA implementation
- Identify, assess, and mitigate quality risks, ensuring proactive issue management and continuous improvement of compliance processes
- Act as a key advisor to business and medicine functions, embedding Quality by Design principles across operations
- Lead non-compliance investigations, root cause analysis, and corrective and preventive action (CAPA) development
- Provide quality analytics, trend analysis, and recommendations to improve processes and decision-making
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