Manager, Global Product Quality Complaints Mgt.

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

Manage the Global Product Quality Complaint (PQC) processing activities at PQC Head Quarters. PQC subject matter expert (SME) responsible for managing, resolving and responding to PQC related inquiries globally from various stakeholders including but not limited to local market Quality Responsible Persons, Distribution & Logistics, Customer Service operations, BMS manufacturing/packaging/release sites, and External Manufacturing quality operations.

Responsible for the processing of and improvements to global BMS PQC processes including but not limited to sample replacement and US market refunds; PQC Triage & Closure; Metrics generation and presentation; PQC training delivery and management; new product launches; PQC related Quality Management System (QMS) support; Author and manage controlled documents (SOPs/Job Aids/Templates); record archivals; quality deviations and CAPA involving PQC HQ and provide quality and compliance oversight for these processes.

Support the management of the global complaint handling process from receipt to closure ensuring quality & compliance with internal and regulatory requirements. Assist in implementation of Quality Risk Management principles in evaluation and investigation of PQCs. Support PQC related audits and inspections as necessary. Participate in QMS business process requirements development and validation activities as necessary.

Major Duties & Responsibilities:

• Provide ongoing SME management and assessment of PQC programs and processes related to the intake of PQCs, determine the appropriateness of processes, implement improvements as appropriate.
• Lead for product return and product replacement processes required for PQC investigation.
• Provide support of Adverse Event (AE)/PQC surveillance processes with Global Pharmacovigilance & Epidemiology (GPVE)
• Development and implementation of PQC training programs
• Identify critical quality issues, escalate through appropriate quality systems and assist in the review and determination of the acceptability of deviation reports and proposed corrective action plans for PQC intake processes and procedures.
• Develop trusting, open and collaborative partnerships while ensuring suppliers have a clear understanding of BMS's quality requirements through established Statements of Work for PQC Head Quarters responsible activity.
• Provide experienced based training to internal and external personnel to ensure compliance with regulations
• Manage all aspects of complaint handling from receipt to closure as necessary
• Assist in the establishment of quality risk management for complaint handling and promote the understanding of risk management for product quality complaints
• Manage all aspects of quality systems, such as documentation, trainings, change controls, quality agreements and computer system validations as necessary for complaint handling
• Establish and generate complaint metrics and Key Performance Indicators (KPIs) to facilitate improvements for end-to-end complaint process
• Support Product Surety and Serialization activities as necessary

Required Knowledge/Skills/Qualifications

Education:

Minimum of a Bachelors Degree required; Health Sciences or Engineering preferred. ASQ Certification in Quality Auditing or Quality Management preferred

Experience/Knowledge:

A minimum of 10 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 working with product quality complaints involving global teams highly desirable. People management experience preferred.

Skills/Competencies:

Subject matter expertise in regulatory requirements and expectations for management of PQCs is required

Strong project management expertise and ability to focus on execution of strategic decisions while balance conflicting priorities

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

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.