GMP Compliance Lead - Client Audits & Mentorship

Alcami Corporation; Charleston (SC); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Alcami Corporation in Charleston, SC, is seeking a Senior Compliance Specialist responsible for ensuring quality and compliance within regulatory requirements. This role supports audit activities and maintains quality databases. The ideal candidate will possess strong regulatory knowledge, conduct audits, and mentor compliance employees.

This hybrid position requires on-site presence for audits and includes travel for site visits. The candidate should have a Bachelor’s or Master’s degree in a related field and extensive experience in the pharmaceutical industry.

Qualifications

• 10+ years of GMP related experience with a Bachelor's degree, or 5+ years with a Master's degree.
• Client hosting and supplier management experience preferred.
• Ability to interact well with employees at all levels.

Responsibilities

• Host client audits and coordinate audit responses.
• Perform quality review of documents and reports.
• Consult with clients on regulatory issues.

Skills

Client-facing experience

Strong knowledge of regulations and SOPs

Good written and oral communication skills

Good computer skills (MS Office)

Ability to negotiate

Ability to lead audits

Ability to act as a consultant

Education

Bachelor’s degree in Chemistry, Biology, or related field

Master’s degree in related field

Job description

Alcami Corporation in Charleston, SC, is seeking a Senior Compliance Specialist responsible for ensuring quality and compliance within regulatory requirements. This role supports audit activities and maintains quality databases. The ideal candidate will possess strong regulatory knowledge, conduct audits, and mentor compliance employees.

This hybrid position requires on-site presence for audits and includes travel for site visits. The candidate should have a Bachelor’s or Master’s degree in a related field and extensive experience in the pharmaceutical industry.