Senior Quality Compliance Specialist, CVRM (Holly Springs)

We are looking for a Senior Quality Compliance Specialist to lead risk-based operational design and data integrity initiatives at our Holly Springs, NC site. You will drive compliance with global regulations and internal standards, collaborating with cross-functional teams. Ideal candidates bring extensive GxP experience and a strong compliance mindset.

Skills

• quality risk management
• data integrity
• gxp compliance
• change control
• fmea
• pha
• fda regulations
• ema regulations
• ich guidelines
• iso standards
• risk assessment
• cross-functional leadership
• inspection management
• product recall management
• supplier management
• metrics & reporting
• health authority engagement
• continuous improvement
• operational excellence
• aseptic manufacturing
• sterile drug product manufacturing
• cross-functional collaboration
• stakeholder engagement