Job Title:
Manager, Global Product Quality Complaints Digital
Location:
Hyderabad, TS, India
Job Summary:
The Manager, Global Product Quality Complaints – Device & Digital will act as a Subject Matter Expert (SME) in managing complaints related to device/combination products and in delivering digital/automation solutions aligned with Bristol Myers Squibb’s (BMS) global digital strategy. This role requires deep expertise in quality assurance, automation, and complaint handling systems within pharmaceutical and biotech environments.
Key Responsibilities:
Serve as SME for complaints involving device and combination products.
Engage Device Quality teams to enhance complaint handling and data processes.
Support risk management and mitigation related to device complaints.
Deliver and maintain digital and automation solutions for Product Quality Complaints (PQC).
Ensure digital solutions comply with internal policies and evolving global regulations.
Manage automation tools/BOTs, resolving operational issues and minimizing processing delays.
Coordinate adverse event investigations and quality data exchange across systems.
Analyze PQC trends using tools like Spotfire and provide technical insights.
Support reconciliation from intake sources and streamline complaint processing.
Provide SME support for Medical Device Reporting and malfunction assessments.
Lead quality risk management initiatives and promote risk awareness.
Manage quality system activities including documentation, training, and system validation.
Collaborate with global metrics teams to generate PQC KPIs and drive process improvements.
Conduct internal inspections and support external audits and inspections.
Act as delegate for PQC triage, surveillance, and systems roles as needed.
Qualifications:
Education:
Bachelor’s degree or higher in Life Sciences, Health Sciences, Engineering, or related field.
Advanced degree preferred.
Qualification/experience in data analytics or automation is advantageous.
Experience:
Minimum 5 years in a pharmaceutical/biotech/device industry quality role with a focus on data analytics or automation.
Prior experience with Product Quality Complaint (PQC) management.
Strong background in device/combination products.
Proficiency in systems such as QMS, SAP/ERP, Veeva, automation tools.
Key Competencies:
Fluency in English with excellent written and verbal communication skills.
Strong data analysis and trend interpretation capabilities.
Ability to propose innovative and automated solutions.
Demonstrated collaboration and stakeholder management across diverse teams.
Strategic thinking, problem-solving, and multitasking in high-paced environments.
Solid understanding of quality compliance, GMP regulations, and risk management principles.
Additional Information:
Onsite requirement based on role classification (site-essential, site-by-design, etc.).
Reasonable accommodations available throughout recruitment and employment processes.
COVID-19 vaccination strongly recommended.
Compliance with local regulations regarding employment practices (e.g., arrest/conviction records in California).
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