Quality Assurance Manager, Product Complaints
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
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