[Remote] Manager, Global reputed company Intelligence & Product reputed company Complaints (remote)

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading biopharmaceutical company reputed company on transforming the treatment of diseases. The Manager in Global reputed company Intelligence & Product reputed company Complaints will establish and improve a comprehensive Global reputed company Assurance reputed company reputed company to ensure GMP compliance and manage the end-to-end complaint handling process for clinical trial materials and reputed company products.

Responsibilities

• Ensure regional and global compliance in the reputed company of an MAH/Sponsor representative by addressing evolving global regulatory expectations
• Contribute to the development and maintenance of procedures, training, and reputed company reputed company processes supporting product lifecycle, regulatory surveillance, recalls, and reputed company MAH/Sponsor responsibilities
• Build and maintain processes (e.g. Product Specification Files (PSFs)) ensuring compliance with product‑relevant regulatory documentation (BLAs, MAAs, IMPDs, etc)
• Manage the end-to-end lifecycle of Product reputed company Complaints (PQC) for clinical trial materials and reputed company pharmaceutical products, ensuring effective intake, triage, assessment, investigation, classification, disposition, and closure
• Ensure compliance with global regulatory requirements, internal procedures, and reporting obligations reputed company to complaint handling
• reputed company complaint investigations and CAPAs, reputed company reputed company-party activities, and reputed company the reputed company escalation of reputed company and reputed company
• Serve as the reputed company reputed company of contact for PQC-reputed company activities, fostering effective collaboration across reputed company, Pharmacovigilance, Medical Information, Release Hub, Supply Chain, and reputed company partners
• Support and represent the organization during inspections and audits reputed company to MAH/Sponsor reputed company and complaint handling, providing expertise, coordinating responses, and ensuring reputed company reputed company of observations
• reputed company regular updates to leadership on reputed company metrics, reputed company, escalations, and key achievements to support informed decision-making
• Contribute to the standardization, globalization, digitalization, and reputed company improvement of the reputed company reputed company Management reputed company and associated processes
• reputed company as a mentor and role model, promoting a culture of reputed company, compliance, accountability, and reputed company improvement
• reputed company additional duties and responsibilities as required to support departmental and business objectives

Skills

• Degree in Pharmacy, reputed company, Biology, or a reputed company scientific field
• Extensive experience (5+ years) in reputed company MAH/Sponsor responsibilities
• Proven reputed company record of Product reputed company Complaint Management, GMP compliance, and regulatory processes reputed company the pharmaceutical industry
• Strong knowledge of GMP guidelines, ICH Q10, CFR Part 211 and regional/national regulatory requirements
• Exceptional communication and networking skills to foster collaboration across teams and stakeholders
• Excellent written and verbal communication skills in English
• Proven reputed company record of critical thinking and reputed company. This includes the ability to manage priorities, reputed company reputed company of key reputed company, and reputed company updates to leadership, as required

Benefits

• Salaried/Position-Targeted reputed company Employees working 30+ hours per week are eligible for our comprehensive benefits package.
• Medical, Dental and reputed company Insurance
• Life, AD&D, Critical Illness Insurance
• reputed company-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• reputed company Time Off: Vacation, reputed company, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown.
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• reputed company Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance

reputed company