Senior Compliance & Audit Lead (Regulatory)

Alcami Corporation; Charleston (SC); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Alcami Corporation is seeking a Senior Compliance Specialist to drive QA and regulatory compliance in a fast-paced pharma environment. Responsibilities include hosting client audits, coordinating audit responses, and mentoring other compliance staff while ensuring cGMP adherence and robust quality systems.

The role requires a strong background in GMP, audits, and regulatory affairs, with on-site presence for client audits and potential travel to other sites.

Qualifications

• Bachelor's degree in Chemistry, Biology, or related field with 10+ years of GMP related experience, or Master's degree in related field with 5+ years of related experience.
• Client hosting experience in the pharmaceutical industry preferred.
• Supplier management experience in pharmaceutical industry is a plus.

Responsibilities

• Host client audits and coordinate with clients.
• Coordinate with internal team members to complete responses.
• Write and coordinate audit responses.
• Perform quality review and approval of documents, data, protocols, and/or reports.
• May assist with supplier quality audits and/or inspections.
• May assist with evaluation of supplier changes and notifications and make assessment of impact accordingly.
• Maintain quality databases and support quality systems.
• Assist with development of SOPs or other quality documents as needed.
• Consult with clients on all levels of regulatory issues.
• Serve as an effective member of the Compliance team and mentor in area of expertise.
• Comply with company policies and SOPs.
• Assist with quality improvement initiatives as needed.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.

Skills

GMP compliance

Audit hosting

Regulatory knowledge

Education

Bachelor's degree in Chemistry, Biology or related field

Master's degree in related field

Tools

Microsoft Office

Job description

Alcami Corporation is seeking a Senior Compliance Specialist to drive QA and regulatory compliance in a fast-paced pharma environment. Responsibilities include hosting client audits, coordinating audit responses, and mentoring other compliance staff while ensuring cGMP adherence and robust quality systems.

The role requires a strong background in GMP, audits, and regulatory affairs, with on-site presence for client audits and potential travel to other sites.