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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

product complaintsinvestigationsroot cause analysisCAPA developmenttrendingdata integrity standardsGMPGCPregulatory complianceclinical-stage products

Soft Skills

interpersonal skillscommunication skillsinfluencecollaboration