Associate Director, Global Product Quality Complaints T500-16896

Job Description

Position:Associate Director, Global Product Quality Complaints

Location: Hyderabad, India

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Position Summary

As the Hyderabad Product Quality Complaints (PQC) Team Lead, you are responsible for the delivery performance and quality of service provided by the HYD PQC team. Reporting to the HYD Global Quality Lead, you will collaborate with the Global Process Owner for Product Quality Complaints to ensure compliant, accurate, timely, and efficient management of Product Quality Complaints and associated data, systems, and processes for BMS products. You will lead the Hyderabad PQC team to process complaints robustly and timely, meeting enterprise and global regulatory requirements. Additionally, you will oversee the PQC surveillance team to manage and analyze data, identify trends, and support effective decision-making. You will also lead the PQC digital team to optimize processes and system interfaces. Continuous communication with management and key stakeholders is essential. You are accountable for the team&aposs performance, compliance, and audit readiness, managing product return and replacement processes, and partnering with global colleagues to resolve issues. You will ensure the team is trained and proficient, support the development of training programs, and promote quality risk management. Leading the surveillance team, you will generate complaint metrics and monitor KPIs to improve processes. You will also support Product Surety/Corporate Security and Serialization activities, manage employee-related activities, and foster a collaborative and empowered team environment.

Key Responsibilities:

- As Hyderabad Product Quality Complaints (PQC) Team lead, you are accountable for the delivery performance and quality of service provided by the HYD PQC team.
- Reporting to the HYD Global Quality Lead, you will work closely with the Global Process Owner for Product Quality Complaints to deliver compliant, accurate, timely and efficient services for the management of Product Quality Complaints and associated data, systems and processes for BMS products.
- Leading the Hyderabad Product Quality Complaints (PQCs) team members to deliver robust and timely processing of Product Quality Complaints (PQCs) to meet enterprise and global regulatory requirements
- Leading the Hyderabad PQC surveillance team to collect, manage and analyze PQC data, highlighting trends, signals and risks and focus areas to PQC Management and Quality Councils supporting effective decision making to protect the organization and our patients and to optimise PQC performance
- Leading the Hyderabad PQC digital team to design, deliver and maintain digital solutions to optimize PQC processes, deliver efficiencies in PQC process performance and optimize system interfaces
- Communicates continuously and effectively with management (Global Quality Lead, Hyderabad, Senior/ Director Product Quality Complaints, Site Quality & Compliance Leadership as appropriate) and key PQC stakeholders on PQC related matters
- Accountable for HYD PQC team delivery of performance and compliance requirements, in alignment with HYD Global Quality Lead, and Senior Director Product Quality Complaints
- Accountable through your HYD team for daily case processing of incoming PQCs while adhering to triage timelines and ensuring compliance to global Health Authority reporting (eg Field Alert Reports, Medical Device Reports, etc)
- Accountable through your HYD team for delivering comprehensive, timely and compliant PQC reports and records for closure to designated Quality approvers across the network
- Accountable for the continuous audit-ready state of the HYD team
- Manage the product return and product replacement processes required for PQC investigation
- Partner with global PQC US/EU colleagues and/or market Quality colleagues and/or network sites and/or third parties to ensure timely resolution to PQC sample return and/or product replacement issues
- Partner with PQC Management, and key stakeholders (intake teams, Medical Information, Safety, Third Parties, PQC Local Process Owners and Investigation sites to optimize the intake & processing of Product Quality Complaints
- Escalate system performance issues to PQC Systems Support for expedited resolution
- Accountable through the HYD team for the optimum performance of digital tools (BOTs, dashboards, Sharepoints, flash reports etc)
- Develop trusting, open and collaborative partnerships while ensuring stakeholders have a clear understanding of BMS&aposs PQC procedural requirements
- Support the development and implementation of PQC training programs including new product launch trainings
- Ensure the local HYD PQC team are adequately trained and proficient to complete required PQC-related actions, in line with BMS policies, procedures and regulatory expectations
- Provide experienced based training and mentoring to PQC HYD team and external personnel supporting PQC processing to ensure compliance with regulations
- Assist in the establishment of quality risk management for complaint handling and promote the understanding of risk management for product quality complaints
- Leading the HYD surveillance team, accountable for complaint metrics generation as well as monitoring of Key Performance Indicators (KPls) to facilitate improvements for end-to-end complaint process
- Support Product Surety / Corporate Security and Serialization activities as necessary
- Grows, develops, engages and empowers team
- Manage employee related activities for the department (hires, trains, appraises, mentors, motivates, disciplines)

The roles, responsibilities and duties prescribed in this job description are descriptive but may not be all inclusive.

Qualifications & Experience:

- Bachelor of Science in Life Sciences (Chemistry, Biology) or Health Sciences.
- Post-graduate qualification preferred.
- A minimum of 7 years of pharmaceutical industry GMP experience and demonstrated leadership in Quality and / or Compliance discipline with in-depth knowledge of global health authorities regulations and requirements. Experience in a senior role with product quality complaints involving global teams and globally distributed products is required.
- A minimum of 3 years&apos experience in a people management role is required.
- Prior employment on a pharmaceutical manufacturing site in a Quality or operations role is an advantage.
- Fluent in English, with proven professional working proficiency in English for reading, writing and speaking
- Excellent communication with management, peers, and other functional areas
- Subject matter expertise in global regulatory requirements and expectations for management of PQCs is required
- Excellent understanding of product formulation* & presentation* types, defect categories applicable to each, and the inherent risk that defect types pose to patient safety *(Solid Oral Dose, Device / Combination, Topical, Liquid / Suspension / Powder / Freeze-Dried Parenteral etc)
- Ability to apply critical thinking in a high-volume, fast-paced environment, in the knowledge that decisions taken support patient safety
- Strong people management expertise and ability to focus on execution of strategic decisions while balance conflicting priorities
- Ability to effectively lead teams to thrive in a fast-paced, highly regulated environment
- Strong communication (written and verbal), leadership, influencing & negotiating and collaboration skills
- Demonstrated ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals & objectives
- Demonstrated ability to make and act on decisions while balancing speed, quality and risk
- Ability to work in a matrix environment and build strong relationships by being transparent, reliable and delivering on commitments
- A continuous improvement mindset
- Ability to build and maintain collaborative relationships with stakeholders in multiple geographic locations by engaging transparently, performing reliably, and delivering on commitments
- Customer and partner focus, including the ability to listen and incorporate feedback from key stakeholders
- Strong analytical skills and ability to deliver meaningful messaging from data analysis
- Financial acumen to meet budget for PQC processing
- Strong working knowledge in software and applications relevant to the role (eQMS eg VEEVA Infinity, ERP eg SAP, artwork eg BAMS, regulatory eg Verity, MS Office Word, Excel, Powerpoint, Sharepoint)
- Commitment to Quality

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to [Confidential Information]. Visit

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