Telangana Global manager, customer complaints Jobs – 3196 Open Jobs Today

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Global Manager, Customer Complaints

DIFGEN PHARMACEUTICALS PRIVATE LIMITED -
Kukatpally, Hyderabad, Telangana

Apply Now

Job details

Qualifications

Quality management
Complaint handling
Master's degree
Analysis skills
Bachelor's degree
Quality control
Mentoring
Organizational skills
Pharmacy
Business Administration
Quality systems
Manufacturing
MBA
FDA regulations

Full job description

Position Summary

The Global Manager, Customer Complaints is responsible for the global oversight, execution, and continuous improvement of the pharmaceutical complaint management program. This role leads a team of complaint investigators and ensures all product quality complaints are properly triaged, investigated, documented, and closed in compliance with international regulations and internal quality standards.

The position serves as a subject-matter expert in complaint handling, partnering with Manufacturing, Quality Control, Supply Chain, Regulatory Affairs, and Pharmacovigilance to drive high-quality investigations, identify root causes, implement CAPAs, and reduce product issues globally.

Key Responsibilities

Complaint Management & Oversight

Lead the end-to-end global complaint process including intake, triage, assignment, investigation, documentation, and closure.
Assign complaints to investigators based on expertise, workload, product knowledge, and investigation complexity.
Ensure complaints are processed in compliance with FDA, EMA, MHRA, Health Canada, WHO, and other relevant regulations.
Review and approve complaint investigations, interim assessments, and final reports for technical accuracy, regulatory compliance, and completeness.
Establish and track performance metrics for complaint processing (e.g., on-time closure, investigation quality, backlog reduction).

Management of Complaint Investigators

Directly lead and develop a team of complaint investigators (onsite, remote, or global).
Provide coaching, technical guidance, and escalation support on complex investigations and root-cause analysis.
Conduct routine 1:1s, performance reviews, and competency assessments for complaint investigators.
Ensure investigators are trained on applicable SOPs, regulatory expectations, and investigation tools/methodologies.
Monitor workload distribution and adjust assignments to ensure timely complaint closure and balanced productivity.
Conduct periodic quality reviews of investigator work, identifying areas for improvement and coordinating retraining when necessary.
Develop and maintain a culture of scientific rigor, accountability, and continuous improvement among the investigation team.

Cross-Functional Collaboration

Partner with Manufacturing, QC, Engineering, Supply Chain, and other functions to ensure timely and effective investigations.
Collaborate with global affiliates to ensure consistent complaint intake, escalation, and documentation.
Work closely with Pharmacovigilance for medical complaint alignment and AE reporting.

Regulatory Compliance & Inspection Readiness

Serve as the subject-matter expert (SME) for global complaint handling during regulatory inspections and audits.
Ensure all investigators are inspection-ready and capable of articulating investigation rationale and methodology.
Lead or support development of responses to regulatory findings related to complaint handling.

CAPA & Continuous Improvement

Ensure CAPAs linked to complaint investigations are clearly defined, risk-based, implemented on time, and verified for effectiveness.
Review complaint trends, perform periodic quality metrics reporting, and identify recurring issues.
Lead global initiatives to improve investigation quality, complaint handling efficiency, and system performance.
Drive harmonization and standardization of complaint investigation procedures across global sites.

Systems Management

Serve as business owner or key user for the global complaint management system (e.g., TrackWise, Veeva QMS, EtQ).
Ensure investigators properly utilize QMS workflows and maintain high data integrity standards.
Partner with IT/TechOps on system enhancements and validations.

Education

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Chemistry, or related field required.
Advanced degree (MS, MBA, PharmD) preferred.

Experience

7–10 years of experience in pharmaceutical or biotech quality systems.
Minimum 3 years directly managing complaint handling, quality investigations, or QA operations.
Experience managing, training, or mentoring investigators strongly preferred.
Experience supporting regulatory inspections (FDA, EMA, MHRA, etc.).

Skills & Competencies

Deep understanding of GMP/GDP regulations.
Strong analytical and root-cause analysis skills (5 Whys, Fishbone, DMAIC, FMEA).
Excellent leadership, communication, and coaching abilities.
Strong organizational skills with experience managing workload prioritization.
Proficiency with electronic QMS platforms.

Key Performance Indicators (KPIs)

On-time complaint closure rate.
Quality of investigations and recurrence reduction.
Investigator performance and capability development.
CAPA effectiveness rate.
Accuracy and timeliness of trend reporting.
Regulatory inspection outcomes related to complaints.

Apply Now

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