Strategic GCP QA Director – Quality & Compliance

SystImmune, Inc.; Princeton (NJ); Hybride; USD 240 000 - 300 000; Plein temps

Avantages offerts par ce poste

401(k) match

PTO

Holidays

Comprehensive benefits

Résumé du poste

SystImmune, a leading clinical-stage biopharmaceutical company with offices in Princeton, NJ and Bothell, WA, is seeking a meticulous Quality Assurance professional with GCP expertise. The role focuses on ensuring clinical trials comply with ICH-GCP, FDA regulations, and internal policies across the lifecycle.

Hybrid work 2-3 days in the office; requires 10+ years in QA with CAPA, audits, vendor qualifications. Salary range $240,000-$300,000 with a comprehensive benefits package.

Qualifications

• Bachelor's degree in life sciences, pharmacy, nursing, or a related field.
• Minimum of 10 years of experience in quality assurance within the pharmaceutical/biotech industry, with a focus on GCP compliance.
• SME in GCP guidelines, ICH-GCP, FDA regulations, and other relevant regulatory requirements.
• Experience conducting GCP audits, inspections, and vendor qualifications/assessments.
• Certification in quality assurance (e.g., Certified Quality Auditor) and/or GCP (e.g., Certified Clinical Research Professional) is desirable.

Responsabilités

• Compliance Oversight: Ensure that all clinical trial activities comply with GCP guidelines, international regulations (e.g., ICH-GCP), and applicable laws.
• Documentation Review: Conduct thorough reviews of study-related documentation, including protocols, investigator brochures, informed consent forms, and CSRs, to verify compliance with GCP requirements.
• Audits and Inspections: Plan, conduct, and/or participate in internal audits and external inspections to assess GCP compliance and identify areas for improvement.
• Training and Education: Develop and deliver internal training programs on GCP principles, regulations, and best practices for relevant stakeholders
• Risk Management: Collaborate with cross-functional teams to identify potential internal or external risks to GCP compliance and develop mitigation strategies to address them effectively.
• Quality Management System (QMS): Maintain and enhance SystImmune’s QMS by implementing processes and procedures that ensure consistent adherence to GCP standards throughout the clinical trial lifecycle.
• Corrective and Preventive Actions (CAPA): Investigate deviations, non-compliances, and quality issues related to GCP and develop CAPAs to prevent recurrence and improve processes.
• Vendor Oversight: Evaluate and monitor the performance of third-party vendors, including contract research organizations (CROs) to ensure compliance with GCP requirements.
• Continuous Improvement: Drive continuous improvement initiatives to enhance the efficiency, effectiveness, and quality of GCP-related processes and procedures.

Connaissances

GCP expertise

Regulatory knowledge

Communication skills

Detail oriented

Formation

Bachelor's degree in life sciences

Description du poste

SystImmune, a leading clinical-stage biopharmaceutical company with offices in Princeton, NJ and Bothell, WA, is seeking a meticulous Quality Assurance professional with GCP expertise. The role focuses on ensuring clinical trials comply with ICH-GCP, FDA regulations, and internal policies across the lifecycle.

Hybrid work 2-3 days in the office; requires 10+ years in QA with CAPA, audits, vendor qualifications. Salary range $240,000-$300,000 with a comprehensive benefits package.