Senior Specialist II: Compliance

Senior Specialist II: Compliance

Work Location: Durham County, NC

Summary:

The Senior Specialist II: Compliance is responsible for supporting and enhancing the Quality Management System (QMS) across internal and external operations, ensuring compliance with Good Manufacturing Practices and Good Distribution Practices as programs transition from clinical to commercial phases. This role partners with cross-functional teams to standardize and manage GxP Deviations, Change Controls, Product Technical Complaints, and Corrective and Preventive Actions (CAPA) throughout their lifecycle.

Responsibilities:

• Guide and harmonize global system metrics, ensuring effective maintenance and monitoring of quality processes.
• Develop and deliver Quality KPIs and analytics, translating data into actionable insights for management and leadership decision-making.
• Review and approve QMS records, including deviations, investigations, change controls, CAPAs, and supplier notifications, providing timely feedback.
• Lead cross-functional risk assessments and governance decisions as Chair of the Change Control Review Board, prioritizing system and process changes.
• Support resolution of Quality Events related to materials, products, testing, facilities, and equipment, both internally and with external partners.
• Monitor Quality Event KPIs, identify systemic risks and trends, and drive improvements in investigation quality, cycle time, and compliance outcomes.
• Facilitate meetings for Change Control, Deviation, and CAPA, escalating issues as needed and acting as a change agent for compliance culture improvement.
• Lead capability-building initiatives, including technical writing and root cause analysis training, and support inspection readiness, audits, and additional quality needs such as material release and batch record review.

Qualifications:

• Bachelor’s or advanced degree in a scientific discipline.
• 10+ years of experience in the pharmaceutical or biotech industry, including drug substance/drug product manufacturing, development, or quality, with at least 2 years working with Quality Management Systems.
• Experience with Change Management and leading culture improvement initiatives.
• Formal training in root cause analysis (e.g., Kepner-Tregoe, Conger Elsea).
• Technical writing experience and/or training.
• Excellent verbal and written communication skills, detail-oriented, and collaborative across functions.
• Ability to apply quality concepts and resolve moderately complex issues effectively.
• Experience with regulatory health authority inspections.
• Strong team player with a customer service and solution-oriented approach.
• Attention to detail and ability to meet deadlines.
• Strong listening, communication, and interpersonal skills to foster team spirit.
• Consistent delivery of high-quality work.
• Experience with Lean Manufacturing and/or Continuous Improvement initiatives.
• Ability to communicate effectively at all organizational levels.

Published Category: Quality & Validation