Sr. Compliance Specialist - Audit , GMP

Responsibilities

• Host client audits and coordinate with clients.
• Cook up and coordinate audit responses.
• Perform quality review and approval of documents, data, protocols, and/or reports.
• Might assist with supplier quality audits and/or inspections.
• Might assist with evaluation of supplier changes and notifications and make assessment of impact accordingly.
• Maintain quality databases and support quality systems.
• Aid in the development of SOPs or other quality documents as needed.
• Consult with clients on all levels of regulatory issues.
• Act as an effective member of the Compliance team and serve as a mentor in area of expertise.
• Comply with company policies and SOPs.
• Aid in quality improvement initiatives as needed.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.
• Other duties as assigned.

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, or equivalent educational and work experience.
• Client hosting experience in the pharmaceutical industry preferred.
• Supplier management experience in pharmaceutical industry is a plus.
• Client-facing experience required.