Audit Compliance Manager — GMP Quality & Regulatory

Alcami Corporation; Durham (NC); On-site; USD 90,000 - 150,000; Full time

Benefits offered by this job

On-site role

Job summary

Alcami Corporation in Durham, NC seeks a Manager of Audit Compliance to lead the audit response team and ensure quality and regulatory compliance. The role includes CAPA management, change control oversight, and supporting audits and inspections.

The position requires 10+ years of related experience, GMP expertise, and strong leadership abilities to drive continuous improvement and timely client responses.

Qualifications

• B.S./B.A./M.S. in a related field with 10+ years relevant experience or equivalent.
• Relevant Leadership and GMP experience required.
• Strong knowledge in audit support areas: Sterile Manufacturing, Oral Solid Dose Manufacturing, Packaging, Warehouse and supply chain, Chemistry Laboratory, or Microbiology.

Responsibilities

• Represents the department in meetings and collaborates to achieve cross-functional improvements.
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
• Manages day-to-day operations for assigned area and ensures staff training.

Education

B.S./B.A./M.S. in a related field

Job description

Alcami Corporation in Durham, NC seeks a Manager of Audit Compliance to lead the audit response team and ensure quality and regulatory compliance. The role includes CAPA management, change control oversight, and supporting audits and inspections.

The position requires 10+ years of related experience, GMP expertise, and strong leadership abilities to drive continuous improvement and timely client responses.