Manager, Global Product Quality Complaints Digital T500-17975

Position Summary:As the Manager, Global Product Quality Complaints Device & Digital, you have expertise and experience in digital tools for optimal PQC processing and have expert knowledge in the management of complaints related to device/combination products. Reporting to the Senior Manager, Global Product Quality Complaints, HYD Lead, you will act as the Subject Matter Expert (SME) for device/combination products complaints, supporting continuous improvement initiatives, risk management, and mitigation strategies. You will also be responsible for delivering digital and automation solutions in line with BMS's digital strategy, ensuring their compliance with internal and global regulatory requirements.

Your role includes designing, operating, and maintaining automation/RPA solutions and collaborating with stakeholders to resolve BOT operation issues, thereby minimizing interruptions to PQC processing. Additionally, you will partner with various teams to ensure effective data exchanges and support for adverse event investigations, identify critical quality issues, and develop corrective actions. You will also provide SME support for PQC trending activities and maintain technical expertise in business applications such as Spotfire.

Key Responsibilities: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 act as the Subject Matter Expert (SME) for processing of complaints related to devices and combination products. Responsible to engage and support Device Quality organization in continuous improvement of device complaint handling and data management.

Responsible to support the risk management and mitigation related to device complaint management. Responsible for delivery of digital and automation solutions in line with the BMS digital strategy for PQC optimization. Ensure quality & compliance of digital solutions and automations with internal and global regulatory requirements, including evolving regulatory landscape.

Accountable for the optimum design, operation and maintenance of automation/BOT solutions for PQC related processes. Responsible to work effectively and collaboratively with stakeholders business partners to escalate and resolve BOT operation issues, in order to minimise interruption to PQC processing and to maintain budget adherance. Provide ongoing management for PQCs ensuring compliance to global framework of GMP policies and BMS procedures

Partner with WWPS to ensure effective exchanges through integrated systems and investigation for Adverse Events with PQC MedDRA codes

Identify critical quality issues and assist in the investigation and implementation of corrective actions.Provide SME support for PQC trending activities using business applications such as Spotfire (PQC-MVT) and maintain technical expertise with regards to its build and operations

Develop trusting, open and collaborative partnerships while ensuring stakeholders (affiliates, sites, functions) have clear understanding of PQC processes from intake to closure

Oversee and improve reconciliation processes from intake sources (Medical Customer Engagement and WWPS)Provide SME support, liaise with ancillary groups for Device/Combination products ensuring robust processes and controls for Medical Device Reporting (MDR) and Device Malfunction assessments

Lead quality risk management activities for complaint handling and promote the understanding of risk management for product quality complaints and surveillance activities and participate in project teams as needed. Manage all aspects of quality systems, such as documentation, trainings, change controls, quality agreements and computer system validations as necessary for complaint handling. Partner with global metrics team and PQC/PS support analytics teams to establish and generate complaint metrics and Key Performance Indicators (KPIs) and facilitate improvements for end-to-end complaint process.

Conduct self-inspections on a periodic basis and provide support during audits and inspections Support Community of Practice forums with collection of topics, content preparation and presentation. Support PQC related audits and inspections as necessary

As required by the Senior Manager HYD PQC Lead:Act as a delegate for Global Product Quality Triage support the management of the Global Product Quality Complaint (PQC) handling process from receipt to closure according to applicable timeframes and in compliance with BMS procedures and regulatory requirements

Act as a delegate for the Manager, Global Product Quality Complaints Surveillance, completing 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. Act as delegate for PQC Systems lead, ensuring optimal performance of system interfaces impacting PQC processing.

Qualifications & Experience:Degree/Certification/LicensureBachelor's degree or higher in Life Sciences (Chemistry, Biology etc) or Health Sciences (Nursing, Pharmacy etc) or related discipline eg Engineering, Pharmaceutical Manufacturing etc. Advanced degree preferred. Qualification or proven experience in data analytics, automation or similar highly advantageous.

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 analyse processes, data and trends, and to translate into effective messaging to stakeholders and leaders supporting effective decision-making

Proven ability to understand complex processes/problems and propose alternate solutions/automated solutions/process enhancements/efficiencies

Experience in management of PQCs related to globally distributed pharma/BIO and device/combination products

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

Highly organized, detail oriented, efficient operator in a fast-paced environment

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 digital needs to functional partners

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

Strong working knowledge/experience with systems such as QMS, SAP/ERP, Veeva, automations

Prior experience in the management of Product Quality Complaints for Pharma/BIO/device/clinical products is an advantage

Experience with device/combination products

Experience 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 skills

Ability to manage multiple, simultaneous projects

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