Senior Manager, GCP Quality Assurance
New
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Spyre TherapeuticsBiotechnology
Remote, USAFull-TimeManager
Salary$149,000 to $175,000
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Job Details
- Experience
- Minimum of 6+ years of experience in the pharmaceutical, biotechnology or related health care industry; Minimum 4+ years of GCP-related Quality Assurance or relevant clinical trial and medical device experience
- Required Skills
- GCPQuality Assurance
Requirements
- BA/BS degree, preferably in biological sciences or related field.
- Minimum of 6+ years of experience in the pharmaceutical, biotechnology, or related health care industry.
- Minimum 4+ years of GCP-related Quality Assurance or relevant clinical trial/medical device experience.
- Strong knowledge of ICH-GCP, GLP, GVP, FDA regulations, and EMA requirements.
- Experience conducting or managing GCP audits of investigator sites, vendors, CROs, and clinical systems.
- Working knowledge of Quality Management Systems, including CAPA, deviation management, and risk assessment.
- Demonstrated ability to analyze regulations and apply quality principles in a practical, risk-based manner.
- Strong organizational, critical-thinking, and problem-solving skills.
- Excellent written and verbal communication skills with the ability to collaborate cross-functionally.
- Ability to travel up to 15% of the time.
Responsibilities
- Provide guidance on GCP, GLP, and GVP requirements to clinical development teams.
- Collaborate with CROs, vendors, and internal stakeholders to promote consistent compliance.
- Develop and execute risk-based audit plans and support inspection readiness initiatives.
- Plan, conduct, and report domestic and international audits of investigator sites and vendors.
- Support investigations related to quality events, protocol deviations, and potential compliance issues, including root cause analysis and CAPA development.
- Track and communicate quality metrics and trends to support continuous improvement.
- Contribute to the maintenance and improvement of the Quality Management System (QMS).
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