Manager, Global Quality Complaint Surveillance T500-17976

Key Responsibilities:Responsible for managing and reporting of accurate and on time Global Quality metrics for Product Quality Complaints (PQC) in a fast-paced environment that support Tier Councils, Product Quality Complaint compliance & trending across the organization, internal & regulatory audits. Expertise with data management and analysis using electronic software solutions, eg VEEVA, Tableau, SpotFire, and Microsoft Office, with focus on Excel, PowerPoint, and SharePoint. Responsible to maintain a high level of knowledge & understanding of Pharmaceutical/Biologic Quality Assurance, Device Quality Assurance, c

Good Manufacturing Practices as applicable in global GMP regulations (including FDA, EMA, MHRA, PMDA, ENVISA, TGA). Responsible to develop & maintain tools and dashboards in support of PQC trending, data surveillance and PQC user support. Responsible to provide PQC data assessments, highlighting trends, signals and risks and business critical information related to Product Quality Complaint data to Quality leadership in a timely fashion.

Data & trend assessments will be communicated with stakeholders in a manner commensurate with risk, and enabling appropriate action taking to protect BMS and our patients. Responsible to complete required training and provide support for Product Complaints, Product Surety and Quality Serialization business process activities. You are accountable for other key activities that support the business such as:SharePoint design, data requests/analysis, and providing communication of trends, signals and risks in addition to business critical information to leadership

Maintain expertise on PQC data management at BMS, including data sources, data quality, data management, data users

Report at appropriate intervals (weekly, monthly, quarterly, year-on-year etc) metrics on key compliance indicators related to PQC performance and procedural compliance (for example on-time closure, increasing/decreasing trends by product/defect category/market etc). Review signals and trends that may present a risk to the organization and/or to our patients. Engage with PQC management and appropriate stakeholders to identify corrective actions.

Align with PQC management for escalations to Quality leadership. Provide recommendations and communications based on output from analytical tools and visualizations. Provide risk assessment support for PQC processes, data management and related activities

Continuously improve process for assessment and reporting PQC data to drive consistency and understanding of Quality compliance-focused metrics

Use Operational Excellence and similar approaches to support the design of metric tools that facilitate proactive discussion and provide visibility/transparency to drive continuous improvement, prioritization and product quality related decisions

Lead teams in the development of tools and reports to optimize and standardize metrics

Lead collection and review of PQC data in response to health authority requests

Lead collection and review of PQC data in support of audit requests (internal and external audits)Lead metrics initiatives related to product quality complaint programs and processes

Facilitate and drive standards for communication, management and visibility of product quality support metrics

Implementation and timely update of information to ensure content is current and accurate

Establish appropriate procedural documents for product quality support metrics

Cross train in other areas of the Global Quality organization to assist the business in developing its employees

Develop and maintain high quality relationships with key stakeholders

Work on multiple projects at one time and manage priorities based on timelines

Work independently with a high degree of professional integrity, be highly organized, and be detail-oriented

Perform duties as aligned with PQC management

Qualifications & Experience:Degree/Certification/LicensureBachelor of Science degree in data analytics/statistics/biostatistics, engineering, chemistry, biology, or other quantitative field.Advanced degree preferred.Required Competencies:Fluent in English, with proven professional working proficiency in English for reading, writing and speaking

Excellent communication with management, peers, and other functional areas

Excellent ability to analyze data to extract useful information and trends, and to translate data to effective messaging to stakeholders and leaders supporting effective decision-making

Ability to work well cross-functionally with stakeholders

Ability to influence positively in a matrix environment

Proven ability to understand complex processes/problems and propose alternate solutions

Customer and partner focus, including the ability to listen to and incorporate feedback from key stakeholders

Demonstrated Enterprise mindset to be able to think and act across functions and divisions

Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives

Excellent teamwork, interpersonal, and communication skills, with the ability to communicate and collaborate with employees and management at all levels and through various formats

Demonstrated strategic thinking capability and ability to balance conflicting priorities

Ability to provide innovative ideas or alternatives that create value including seeking new information and external insights without compromising compliance

Ability to clearly articulate analytical needs to functional partners

Experience – Responsibility and minimum number of years:A minimum of 5 years of experience in a data analytical role, or in a Quality role where data analytics was a key component in the pharmaceutical/ biotech/ device industry

Strong working knowledge/experience with systems such as QMS, SAP/ERP, VeevaExperience with understanding how to respond to trend signals within the context of quality surveillance

Strong problem solving skills are required

Strong program and project management

Ability to manage multiple, simultaneous projects

Thorough understanding of Quality Risk ManagementMastery of relevant Quality compliance processes and regulations

Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological