Remote Senior Manager, Quality & R&D Audits (GPV/GLP)

Proclinical; New York (NY); Remote; USD 160,000 - 175,000; Full time

Job summary

Proclinical is seeking a Senior Manager, Corporate Quality - R&D Audits to lead the external vendor audit program, ensure GPV and GLP-GCLP compliance, and support global regulatory requirements across the organization's R&D activities from a remote US based role.

This role partners with cross-functional teams, develops audit plans, reviews responses, and maintains records while traveling up to 20% domestically and internationally.

Qualifications

• Degree in Life Sciences or a related field.
• Experience in pharmaceutical or biotech drug development with GPV and GLP-GCLP auditing.
• Strong knowledge of OECD GLP, GPV, ICH E6 GCP, FDA, and EU requirements.
• Excellent interpersonal skills and ability to build cross-team relationships.
• Willingness to travel up to 20% domestically and internationally.

Responsibilities

• Conduct external audits of approved vendors with audit plans and reports.
• Perform quality audits for qualification of new vendors.
• Conduct for-cause audits of external vendors as requested by management.
• Review vendor audit responses for compliance with standards and guidelines.
• Act as QA contact for vendor audits, performance oversight, and compliance decisions.
• Support maintenance of annual external audit schedules.
• Provide assistance during GxP health authority inspections.
• Revise and create GxP quality documentation, such as SOPs, policies, templates, and work instructions.
• Manage auditing files, records, licenses, and certificates related to the approved vendor program.
• Take on additional responsibilities as assigned.

Skills

GPV auditing

GLP-GCLP auditing

Regulatory compliance

Vendor management

Interpersonal skills

Education

Degree in Life Sciences or related field

Job description

Proclinical is seeking a Senior Manager, Corporate Quality - R&D Audits to lead the external vendor audit program, ensure GPV and GLP-GCLP compliance, and support global regulatory requirements across the organization's R&D activities from a remote US based role.

This role partners with cross-functional teams, develops audit plans, reviews responses, and maintains records while traveling up to 20% domestically and internationally.