Job Description:
• Provide strategic quality oversight for the intake, investigation, and management of clinical-stage combination product complaints.
• Ensure compliance with global GMP, GCP, and pharmacovigilance requirements.
• Collaborate closely with key stakeholders to ensure timely, compliant investigations, effective CAPAs, and inspection-ready documentation.
• Safeguard patient safety, product quality, and regulatory compliance throughout clinical development.
• Interact with all areas of Clinical, Regulatory Affairs, and Pharmacovigilance.
• Engage with CROs and CMOs for regulatory inspections and audits.
Requirements:
• Bachelor's degree and 7+ years of experience OR
• Master's degree and 4+ years of experience
• PhD and 2+ years of experience may be considered
• Hands-on experience with product complaints and investigations required
• Strong understanding of cGMP, GCP, and global regulatory requirements related to clinical product complaint handling.
• Proven experience managing complaint investigations, root cause analysis, CAPA development, and trending for clinical-stage products.
• Demonstrated success supporting regulatory inspections and audits involving complaint systems and quality investigations.
• Strong interpersonal and communication skills with the ability to influence cross-functional and external partners.
• Experience with electronic quality management systems (e.g., Veeva) and deep understanding of data integrity standards.
• Experience with electronic quality systems (e.g., Veeva) and strong proficiency in data integrity standards.
Benefits:
• Medical coverage
• Dental coverage
• Vision coverage
• Life insurance
• Disability insurance
• 401(k) savings plan
• Flexible spending accounts
• Employee assistance program
• Tuition reimbursement program
• Voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
• Sick time policy
• Flexible vacation policy
• Parental leave policy