EPM Scientific
Quality Assurance – Principal Recruitment Consultant at EPM Scientific
Position:
Quality Compliance Lead
We are seeking a Quality Compliance Lead to oversee internal compliance audits and ensure adherence to global quality standards. This role is critical for maintaining inspection readiness and driving continuous improvement across site operations.
Key Responsibilities:
Develop and manage the site self-inspection program, including schedules and agendas.
Conduct planned and unplanned inspections; document and communicate findings.
Track and verify CAPAs for effectiveness; provide guidance to ensure robust corrective actions.
Prepare trend reports and share insights to identify improvement opportunities.
Support audit readiness and participate in regulatory and internal audits.
Perform external audits of suppliers as required.
Deliver training and coaching to site teams on audit processes and compliance.
Qualifications:
Bachelor's degree in Science, Engineering, or related field.
10+ years in a GxP environment with strong knowledge of cGMP and global regulations (FDA, EMA, ICH, ISO).
Expertise in quality systems and compliance auditing.
Must be authorized to work in the US without Visa Sponsorship.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Location: Burlington, VT
#J-18808-Ljbffr
Quality Compliance Lead
We are seeking a Quality Compliance Lead to oversee internal compliance audits and ensure adherence to global quality standards. This role is critical for maintaining inspection readiness and driving continuous improvement across site operations.
Key Responsibilities:
Develop and manage the site self-inspection program, including schedules and agendas.
Conduct planned and unplanned inspections; document and communicate findings.
Track and verify CAPAs for effectiveness; provide guidance to ensure robust corrective actions.
Prepare trend reports and share insights to identify improvement opportunities.
Support audit readiness and participate in regulatory and internal audits.
Perform external audits of suppliers as required.
Deliver training and coaching to site teams on audit processes and compliance.
Qualifications:
Bachelor's degree in Science, Engineering, or related field.
10+ years in a GxP environment with strong knowledge of cGMP and global regulations (FDA, EMA, ICH, ISO).
Expertise in quality systems and compliance auditing.
Must be authorized to work in the US without Visa Sponsorship.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Location: Burlington, VT
#J-18808-Ljbffr