Manager Quality Systems DC QA

Profile

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 has responsibility for providing quality compliance oversight to enterprise resource planning systems, controls and strategy at the US/PR 3PL Distribution Centers (Mount Vernon IN, Manchester PA, Guaynabo PR), and oversight of the QMS. Supports the Lead, Quality Distribution US/PR for product hold communications and market action implementation and management. Manages and approves transactions for the SAP Quality Module and 3PL inventory management systems for US SAP DC plants. Troubleshoots SAP issues. Supports the Manager, DC QA in ensuring GMP/GDP compliance at DCs. Supports investigation of deviations/ discrepancies and product quality complaints with 3PLs and manufacturing sites. Reviews and approves procedural documents, written agreements, protocols/reports, shipment approvals and deviations. Provides SME support and SAP QM training to internal and external manufacturing oversight for sites that send product to the DC SAP plants.

Responsibilities:


Provides oversight for establishment of SAP QM master datain support ofeffective Supply Chain processes.
Monitors and facilitates SAP transactions for DC Plants as required.
Provides training as needed to External Manufacturing Supply Chain and Quality for SAP QM master data set-up, maintenance and troubleshooting.
Assists in resolving SAP issues related to lot status; SAP transactions for material on quality status; RedPrairie-SAP synchronization.
Participates on ERP projects as SME. Supports the product hold communication process, and the market action implementation and management processes.
Maintains a high commitment to quality compliance and good distribution practice.
Maintains the quality management system for oversight of the 3PL DCs.
Understands the regulatory environment and works proactively to support that the state of the industry is maintained.
Ensuresinspection readiness and the overall Quality strategy for the US/PR distribution centers.
Supports Quality strategy for storage, transportation, and distribution of commercial product, physician samples, and donations.
Supports GMP audits/inspections by external agencies and internal compliance groups.
Assists in the inspection preparation, issue resolution, and response process. Ensures inspection readiness.
Responsible for review, categorization, and approval of customer complaints associated to the DC and associated storage, transportation, and distribution of products usingthe designated deviation managementsystem.
Conducts evaluation of distribution short-overage-damage (SOD) complaints to determine if a Product Quality Complaint investigation is required.
Determines if the complaint is forwarded to production site or 3PL DC for investigation.
Works with 3PL DC to close SOD complaints as necessary.
Conductsregular monitoring of DC floor and systemic operations including the Quarantine/Reject areas.
Conducts GMP/GDP audits of transportation and logistics service providers.
Provides quality support for inspection/redress/repacking of product at the DC, as necessary. Reviews and approves related documentation as required.
Provides support as required for quality events related to the storage, transportation, and distribution of product.
Provides quality support for the system that ensures that product is stored in accordance with the labeling requirements and that product transportation and distribution conditions are in accordance with approved BMS requirements.
Reviews temperature recording data and determines product suitability for distribution.
If there is a deviation that could potentially impact product quality, ensures that product is placed in the appropriate system status to prevent distribution. Develops Quality SOPs as required.
Supports the implementation of Product Hold Notices, including notification process. Supports investigations covering reconciliation and verification of inventory.
Supports GMP training for DC personnel.May provide training. Provide quality approval for disposition of material returned to the DC. Under the overall Compliance Management role, supports the fact-finding investigation (FIT) and review (FIRM) processes and resulting Product Review and Product Action Committees as assigned.
Supports compliance to Global Quality policies and directives for storage, transportation and distribution activities.
Provides Site Gatekeeper functions for change controls involving supply and logistics.


Required Knowledge/Skills/Qualifications

Education:

Requires a minimum of a Bachelor of Science degree in a science-related discipline or engineering.

Experience/Knowledge:


Understanding of technical areas related to pharmaceutical manufacturing, transportation and distribution, regulatory, and Quality Control/Quality Assurance processes.
Knowledge of Quality processes and regulations, e.g., GMP/GDP/GxP regulations. An understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality and complaint investigations.
Experience in inventory control and warehouse management computer systems such as SAP and RedPrairie.
Competency in using deviation management systems e.g., TrackWise, Veeva
Knowledge of product attributes as they relate to regulation both domestically and internationally.
Direct experience in a Quality Assurance role.
Logistics experience desirable.
Knowledge of effective styles of communication and change management.
Ability to analyze and solve complex problems.
Ability to work independently and use initiative.
Ability to prioritize work and rapidly change priorities when necessary.
Ability to develop win/win solutions.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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 with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1527003_EN

Updated: 2020-06-29 00:00:00.000 UTC

Location: Mount Vernon,Indiana

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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