Product Quality Complaints Analyst

Participate in the Global Product Quality Complaint (PQC) operations at the PQC Head Quarter (PQC HQ), with the primary responsibility of review and triage of incoming complaints. Facilitate communications for individual complaint records as necessary between PQC HQ function, Medical Information Contact Centers, Local Market representatives, internal sites, and external manufacturing operations. Identify any compliance gaps and inefficiencies and provide input in implementation of solutions. Support the management of the global complaint handling process from awarenss to closure ensuring quality & compliance with internal and regulatory requirements. Assist in other PQC related activites such as reconciliation processes, metrics generation, audit support, generation of ad hoc queries, etc. as directed by PQC management

Primary responsibilities:

• Peform accurate review, evaluation and assignment of incoming product quality complaints within established timeframes
• Assess reported information for completeness and determine the complaint category/s, release/manufacturing/packaging site, local market and site PQC process owners, and ensure accurate and timely triage of incoming PQCs.
• As appropriate facilitate the collection of additional complaint information relevant for the investigation
• Assist in the product return, replacement and reimbursement processes for complaint investigation samples
• Ensure that complaints which require expedited review are identified and escalated to appropriate local markets, sites and senior management promptly per established procedures Resolve day-to-day triage assignment inaccuracies and issues Perform review and closure of PQCs upon completion of investigations per established procedure and timeframes Upon request by PQC HQ Management, perform the following support activities:
• Periodic product quality complaint metrics
• Generation of ad hoc reports
• Reconciliation of complaints received and transferred between organizations (e.g., Pharmacovigilance, Medical Information) to ensure allare documented as required in the Quality Management System for accountability of all PQC cases globally.
• Provide support during internal/external audits and inspections Provide backup coverage for the other day-to-day activities of the PQC HQ department, such as management of PQC general mailbox, SharePoint sites, archival of documents, etc. Provide support to Product Surety and Serialization management as requested Perform other duties as assigned by PQC HQ management.

Degree:

Minimum of a Bachelor's Degree required, Sciences, Pharmacy, Nursing, Chemical or Bio-Medical Engineering or related fields.

Experience:

A minimum of 7 years of pharmaceutical industry experience with at least 3 years in handling of Product Quality Complaints.

Global experience working in mid to large biopharmaceutical with prescription drug dosage forms and combination products

Skills and Competencies:

• Critical thinking to understand and operate under complex global environment.
• Demonstrated experience working with complex processes, detailed, organized, and ability to multi-task, balance conflicting priorities
• Excellent verbal and written communication in English
• Ability to work cross-fuctionally within the organization with all levels of leadership
• Ability to build strong relationships by being transparent, reliable and delivering on commitments
• In addition to English, bilingual ability in either of the languages - French/German/Spanish/Mandarin/Japanese will be preferred