Quality Assurance Manager-CRO Experience(Remote Contractor/Part Time)

ZipRecruiter; King of Prussia (Montgomery County); Remote; USD 60,000 - 100,000; Part time

Job summary

A leading company in the pharmaceutical sector seeks a Quality Assurance (QA) Manager to support their QA teams remotely. The ideal candidate will possess extensive QA expertise within CRO environments, excel in managing audits, and drive corrective actions effectively. This part-time/contract role requires someone available immediately to enhance documentation and align processes with industry standards.

Qualifications

• 5+ years of QA experience in a CRO or pharmaceutical environment.
• Strong knowledge of GCP, ICH guidelines, and FDA audit processes.
• Hands-on experience with validation of electronic systems.

Responsibilities

• Collaborate with biopharmaceutical QA teams on audit findings.
• Develop and implement corrective action plans.
• Provide QA leadership for audit resolution activities.

Skills

Quality Assurance

Communication

Problem-solving

Tools

SOPs

SAS software

Job description

Job DescriptionJob Description

Remote (U.S.-based )

We are seeking a Quality Assurance (QA) Manager with extensive experience in pharmaceutical QA and a background in CRO environments to join our team on a part-time or contract basis. This role will provide immediate, expert-level support for addressing complex audit findings from pharmaceutical sponsors.

Your role will focus on:

• Collaborating directly with our biopharmaceutical QA teams to address outstanding audit findings.
• Developing and implementing corrective action plans to close identified gaps.
• Providing QA leadership and serving as the primary point of contact for all sponsor-related audit resolution activities.
• Reviewing and enhancing documentation, validation evidence, and QA processes to align with industry standards and sponsor expectations.

Key Qualifications

5+ years of QA experience within a CRO, pharmaceutical, or biotech environment.
Proven success in managing and resolving complex sponsor audits, including major findings.
Strong knowledge of GCP, ICH guidelines, FDA, and sponsor audit processes.
Hands-on experience with SOPs, validation of electronic systems (e.g., sFTP portals, SAS software), and QA best practices.
Excellent communication skills, especially in liaising with sponsor QA teams.
Ability to work independently, manage priorities, and drive audit resolution to completion.

Position Details

• Part-time or contract-based engagement.
• Remote work; U.S. time zone for better sponsor collaboration.
• Immediate availability highly desired.

Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com