Senior Manager, Corporate Quality - R&D Audits (GVP)

Proclinical; New York (NY); Teletrabalho; USD 160 000 - 175 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

GPV auditing

GLP-GCLP auditing

Regulatory compliance

Vendor management

Interpersonal skills

Formação académica

Degree in Life Sciences or related field

Descrição da oferta de emprego

Senior Manager, Corporate Quality - R&D Audits - Permanent - Remote US

Are you ready to make a groundbreaking impact in the world of biotechnology? Join a growing company that's shaping the future of healthcare and science.

Proclinical is seeking a Senior Manager, Corporate Quality - R&D Audits to oversee vendor management and audit programs with a focus on GPV and GLP-GCLP vendor audits.

Primary Responsibilities:

This role ensures compliance with global regulatory requirements, supports the integration of acquired programs, and drives continuous improvement in quality systems.

Key Skills and Requirements:

• Degree in Life Sciences or a related field.
• Experience in pharmaceutical or biotech drug development, with expertise in GPV and GLP-GCLP auditing.
• Strong knowledge of OECD Principles on GLP, GPV, ICH E6 GCP Guidelines, FDA regulations, and EU requirements.
• Excellent interpersonal skills, integrity, and the ability to build strong working relationships across teams.
• Willingness to travel domestically and internationally up to 20% of the time.

Senior Manager's responsibilities will be:

• Conduct external audits of approved vendors, including developing audit plans, preparing reports, and escalating findings as needed.
• Perform quality audits for the qualification of new vendors.
• Conduct for-cause audits of external vendors as requested by management.
• Review and evaluate vendor audit responses to ensure compliance with industry standards and guidelines.
• Act as a QA point of contact for vendor-related audits, performance oversight, and compliance decisions.
• Support the 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, reports, licenses, and certificates related to the approved vendor program.
• Take on additional responsibilities as assigned.

Compensation

• $160,000 to $175,000 per annum.