Bristol Myers Squibb Company

Sr. Manager Quality Risk Management (QRM)

Location
Seattle, WA, United States
Posted
Sep 04, 2020
Ref
R1528958
Discipline
Quality, Quality Control
Required Education
Masters Degree/MBA
Position Type
Full time
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.

About Bristol-Myers Squibb

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.

PURPOSE AND SCOPE OF POSITION:

The Risk Management Sr. Manager is a full-time position responsible for Quality Risk Management (QRM) business process and program across the Cell Therapy Development and Operation (CTDO).The role can be located in Seattle,WA or Summit,NJ.

This position will serve as a liaison for the CTDO QRM strategy development, implementation of new initiatives and improvements, and will provide guidance and support to the Cell Therapy manufacturing sites regarding management and harmonization of the QRM program.

REQUIRED COMPETENCIES: Education, Knowledge, Skills, and Abilities:

Education:

Degree in biology, chemistry, engineering or other related field.

Experience

9+ yrs of GMP/Industry experience

Preferably 7+ year's risk management experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA.

Qualifications
  • Strong experience and thorough understanding of risk management tools with in-depth knowledge of cGMPs and applicable FDA regulations guidelines and industry best practices
  • Extensive level of experience with performing risk assessments using a variety of tools (e.g. FMEA, FTA, HACCP, etc).
  • Strong project planning skills
  • Strong technical writing skill set and be able to critically review reports while effectively inputting and expressing Quality principles.
  • Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships within CTDO
  • Proven experience working as a detailed oriented team player with effective planning, organization and execution skills
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement.
  • Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables.
  • Able to manage multiple priorities.
  • Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System).
  • Must complete tasks independently, notify supervisor of decisions outside of established processes and the ability to build an internal network.
  • Experience in a GxP (GLP, GMP or GCP) regulated environment


DUTIES AND RESPONSIBILITIES:

Primary responsibilities include:
  • Identify and implement risk management principles, methods and tools and author appropriate policies, procedures, and reports for the CTDO Quality Risk Management (QRM) Procedures (SOPs) and Work Instructions (WP)
  • Develop and maintain documentation to track key risk information and provide risk reporting to include both quantitative and qualitative risk information.
  • Evaluate and report key performance metrics, analyze data and lead improvement initiatives.
  • Drive continuous improvement for effective risk management and to address recurring issues identified throughout CTDO sites.
  • Lead, facilitate, coach, mentor and provide technical expertise for root cause analysis and improvement initiatives across Dexter functional areas.
  • Track and verify appropriate corrective actions have been implemented, documented and align with source event.
  • Track the status of risk mitigation actions through to completion.
  • Schedule and lead Dexter risk assessment activities to identify risk areas and implement risk mitigation measures to support CTDO supply, compliance and business continuity.
  • Facilitate and participate in cross-functional risk assessment teams to assess the integration and implementation of new products and/or processes transitioning CTDO sites.
  • Facilitate planning, execution and completion of risk assessments by providing direction, and guidance to staff and applicable departments.
  • Ensure that any changes or impacts to the QRM systems are communicated and agreed to by the CTDO sites, teams and project sponsors.
  • Ensure product risk management documentation/files are maintained, with good documentation practices and in compliances with CTDO Quality System.
  • Manage and coordinate integration of QRM in different elements of Quality Systems.
  • Conduct risk reviews and escalate findings, as appropriate, to CTDO Leadership with resolution recommendations.
  • Partner with other company risk management stakeholders, including Validation, Manufacturing, Clinical Operations, Patient Scheduling, Facilities, and Safety. -
  • Assure the deliverables, milestones, and objectives for QRM are developed to ensure success for the program(s).
  • Develop and conduct user training for QRM for Dexter Corporate Office personnel. (This includes new hire and routine training for QRM.)
  • Perform routine and ad hoc QRM metric reporting and analysis for the Dexter Corporate Office data.
  • Prepare metrics and perform periodic trend analysis in support of CTDO management review. Own and harmonize the CTDO metrics across sites.
  • Provide communication as to the status of QRM deliverables to customers, management and stakeholders.
  • Act as Subject Matter Expert (SME) to support cross functional groups for QRM functions.
  • Act as a QRM SME during internal, external and regulatory audits .
  • Support internal, external audits and regulatory inspections. ( data gathering, interviewing or escorting auditors during the audit)
  • Participate in the Risk Management program, including updating risk analyses, participating in applicable teams and maintaining Risk Management documents.
  • Support corporate requests for compliance and regulatory assessments.


BMSCART

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.