This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, GQC Support based in United States.
This is an excellent opportunity for a quality and compliance professional to lead critical support functions within a global Quality Management System (QMS) environment. In this remote role, you will oversee documentation, training, audit support, and continuous improvement initiatives that help maintain regulatory compliance across pharmaceutical and biotechnology operations. Working closely with cross-functional teams, you will play a key role in ensuring quality processes remain efficient, inspection-ready, and aligned with industry standards. The position combines operational leadership, regulatory expertise, and process optimization, offering the chance to contribute directly to healthcare innovation while supporting high-impact quality initiatives across the organization.
This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Manager, GQC Support based in United States.
This is an excellent opportunity for a quality and compliance professional to lead critical support functions within a global Quality Management System (QMS) environment. In this remote role, you will oversee documentation, training, audit support, and continuous improvement initiatives that help maintain regulatory compliance across pharmaceutical and biotechnology operations. Working closely with cross-functional teams, you will play a key role in ensuring quality processes remain efficient, inspection-ready, and aligned with industry standards. The position combines operational leadership, regulatory expertise, and process optimization, offering the chance to contribute directly to healthcare innovation while supporting high-impact quality initiatives across the organization.
Accountabilities:
- Oversee the lifecycle management of controlled documents, ensuring Standard Operating Procedures (SOPs) are maintained, reviewed, formatted, and updated in accordance with internal quality standards and regulatory requirements.
- Manage Quality Management System (QMS) support activities, including training administration, training matrices, learning materials, document management systems, and change control processes.
- Coordinate and administer Corrective and Preventive Action (CAPA) activities, including documentation, effectiveness checks, process monitoring, compliance tracking, and continuous improvement initiatives.
- Lead regulatory inspection and client audit support by coordinating schedules, logistics, documentation, secure information sharing, audit tracking, and record retention activities.
- Provide administrative support for the Global Quality Compliance function by preparing meeting agendas, recording minutes, tracking quality metrics, and assisting with departmental projects and process improvements.
- Collaborate with cross-functional teams to maintain compliance with global pharmaceutical regulations while identifying opportunities to improve operational efficiency and quality processes.
- Support occasional onsite regulatory inspections and client audits through limited business travel as required.
- Bachelor's degree in Life Sciences, Clinical Sciences, Business, or a related discipline.
- Minimum of 5 years of Quality Assurance, Quality Compliance, or auditing experience within a Good Clinical Practice (GCP) environment.
- Previous experience working within a Contract Research Organization (CRO).
- Experience supporting regulatory inspections and hosting client audits.
- Strong knowledge of pharmaceutical and biotechnology regulations, including ICH, GCP, GxP, FDA/CFR, EMA, MHRA, and EU GVP requirements.
- Hands-on experience managing CAPA programs, Quality Management Systems, SOP lifecycle management, document control, and process improvement initiatives.
- Previous supervisory or managerial experience is preferred.
- Proficiency with Microsoft Office Suite, SharePoint, document management systems, learning management systems, and other quality-related technologies.
- Strong communication, presentation, analytical, organizational, and problem-solving skills with the ability to manage multiple priorities independently.
- High level of integrity, attention to detail, confidentiality, collaboration, and relationship-building skills within regulated environments.
- Exposure to software application development or maintenance is considered an asset.
- Competitive salary.
- Flexible remote work environment.
- 401(k) retirement plan with company matching contributions.
- Discretionary Paid Time Off (PTO) and paid holidays.
- Medical, dental, and vision insurance.
- Health Savings Account (HSA) and Flexible Spending Account (FSA) options.
- Telemedicine services for virtual healthcare appointments.
- Wellness program and Employee Assistance Program (EAP).
- Tuition reimbursement and career growth opportunities.
- Adoption assistance.
- Short-term and long-term disability coverage.
- Life insurance.
- Employee discount programs.
Requirements:
Benefits: