Principal Specialist QMS QA

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The Principal Specialist, Quality Assurance (QA) Quality Management System (QMS) is responsible for reviewing good manufacturing practices (GMP) documentation and ensuring that commercial products and materials meet required quality characteristics. QA is responsible for the technical aspects of quality assurance as it relates to the products and changes or events that may impact the products. The Principal Specialist, QA QMS works within the QA team to establish and maintain quality assurance systems necessary for ensuring operations are in compliance with current Good Manufacturing Practices.

The Principal Specialist, QA QMS will also work cross-functionally to ensure that GMPs are followed while maintaining an efficient and effective program to meet production requirements. In addition, the incumbent is responsible for support and leadership within the Local Process Owner Organization(s) to continuously improve and harmonize global Quality Systems.

REQUIRED COMPETENCIES:

* Requires advanced knowledge of current Good Manufacturing Practices (cGMP), Occupational Safety and Health Administration (OSHA), United States Pharmacopeia (USP) and European Pharmacopoeia (EP)

* Advanced knowledge of Quality Systems:
Deviations, Corrective Action Preventive Action (CAPAs), Change Management, Product Quality Complaints

* Advanced knowledge of Validation Program

* Advanced knowledge of Risk Management

* Ability to critically assess project(s) and allocates resources to efficiently achieve goals

* Ability to multi-task and be flexible

* Advanced teamwork and facilitation skills

* Advanced critical reasoning and decision-making skills

* Able to fully interpret results and situations and articulate recommendations for resolution

* Ability to broaden technical and scientific knowledge

* Intermediate to advanced knowledge of fundamental scientific problems

* Ability to provide input and build relationships internally and with cross-functional teams

* Able to implement solutions independently

* Able to write and review reports with clarity and brevity

* Able to produce data reports with precision

Key Responsibilities

* Independently performs QA review and approval of Deviations, Change Controls and CAPAs

* Primary lead for complex Deviations

* Independently performs QA review and approval of Change Control Requests (e.g., DCCs, CCRs) to ensure the proposed changes are justified, supported by data and have been appropriately validated where applicable

* Leads Investigations of Product Quality Complaint (PQC) investigations

* Interfaces with all other quality groups within the company on quality systems issues

* Responsible for conducting QA review and approval of Validation, Engineering and Quality Control protocols, test plans and summary reports. This responsibility includes Installation Qualification/Operational Qualification/Performance Qualification (IQ/OQ/PQ) of equipment, process, facility, and method validation approvals

* Works with Plant Operations to ensure compliance with and understanding of cGMPs, standard operating procedures (SOPs), and policies

* Provides guidance to other employees in interpretation of complex data

* Leads assigned projects/initiatives

* Recognized Subject Matter Expert within the group

Provide sitewide oversight of status and compliance of records in the Quality Management System.

* Ensures reports are available for record statuses.

* Designs and enforces processes to ensure department-level ownership of quality record status

* Utilizes site/department Tier processes to highlight quality records, including timeliness and criticality.

Supports the site and Global Quality through the Local Process Owner (LPO) network.

* Functions as an LPO for various quality record processes (investigations, change controls, complaints, actions).

* Supports quality system enhancements in coordination with global teams.

* Maintains tools provided by global teams such as playbook, rubric and global checklists.

* Manages the site Change Control Review Board, Investigation Review Board (IRB), Deviation Review Board (DRB) and Triage processes.

* Manages the use of…