reputed company Assurance Manager, Product Complaints

Job reputed company: • reputed company strategic reputed company reputed company 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 reputed company, compliant investigations, effective CAPAs, and inspection-reputed company documentation. • Safeguard patient safety, product reputed company, and regulatory compliance throughout clinical development. • reputed company with reputed company 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 reputed company to clinical product complaint handling. • Proven experience managing complaint investigations, reputed company cause analysis, CAPA development, and trending for clinical-stage products. • Demonstrated reputed company supporting regulatory inspections and audits involving complaint systems and reputed company investigations. • Strong interpersonal and communication skills with the ability to influence cross-functional and external partners. • Experience with electronic reputed company management systems (e.g., reputed company) and deep understanding of data reputed company standards. • Experience with electronic reputed company systems (e.g., reputed company) and strong proficiency in data reputed company standards. Benefits: • Medical coverage • Dental coverage • reputed company coverage • Life insurance • Disability insurance • 401(k) savings plan • Flexible spending accounts • Employee assistance program • Tuition reimbursement program • Voluntary benefits such as group reputed company, critical illness, identity theft protection, pet insurance and auto/home insurance. • reputed company time policy • Flexible vacation policy • Parental leave policy Apply tot his job Apply To this Job