Job Title: QA Manager GCP
Location: North Carolina
Job Overview:
We are seeking a QA Manager with expertise in GCP to join a team in North Carolina. As part of a leading Contract Research Organization (CRO), you will be responsible for the maintenance and compliance of the Quality Management System (QMS), supporting global operations, clinical services, and key stakeholders. This role demands a proactive individual who ensures quality principles and regulatory requirements are met, safeguarding patient safety and the integrity of clinical operations.
Key Responsibilities:
- Ensure the QMS is maintained in accordance with quality principles, GCP requirements, and regulatory standards.
- Provide quality support to global operations, including clinical services, while engaging with key stakeholders to uphold compliance.
- Establish and maintain a compliant quality system to meet regulatory and company expectations, ensuring all license provisions are observed.
- Ensure the Quality Assurance team has adequate resources and capabilities. Oversee personnel training and development in line with role requirements.
- Proactively identify risks, implement preventive measures, and ensure operations do not compromise patient safety or product quality.
- Review, support, and drive the completion of key quality records, including Change Controls, Deviations, CAPAs, and risk assessments.
- Oversee supplier and vendor qualifications, ensuring compliance and quality in partnerships with third-party contractors.
- Support the validation of all GxP-regulated systems, including equipment and computer systems, to maintain regulatory compliance.
- Act as a point of escalation for issues related to clinical sites, vendors, and third-party contractors, driving operational quality and compliance.
Qualifications:
- Proven experience in a Quality Assurance management role within a GCP-regulated environment.
- Strong understanding of QMS, GCP, and other regulatory requirements.
- Excellent leadership and team management skills with a focus on training and development.
- Ability to identify, assess, and mitigate risks proactively.
- Experience in managing quality records, including CAPAs, Deviations, and Change Controls.
- Effective communication and stakeholder management skills.
- Strong problem-solving skills with the ability to handle complex quality issues.