Quality Systems Senior Specialist EXM Americas

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.

Summary :

The Quality Systems SeniorSpecialist is responsible for implementing, supporting and monitoring of the effectiveness of the Quality Systems and Training within the Global External Manufacturing organization.

Responsibilities:

Operations Support


The Quality Systems Senior Specialist will be responsible for providing day-to-day support to ExM Operations on Quality Systems that enable business objectives to be achieved. This may include:
Participate in and support Permanent Inspection Readiness activities
Maintain the Quality Risk Register for ExM
Monitor the periodic review of Quality Systems documents
Maintain the system and process for record management
Maintain the system for update of ExM GxP Authorizations
Act as facilitator and reviewer of Quality System Framework updates
Act as ExM Quality Systems representative on ExM and Global Quality projects
Support the scheduling, execution, reporting, follow up and tracking of self-inspections audits.
Support preparation of and participate in Quality Council meetings
Perform self-inspection audits as part of the audit team.
Identify and implement continuous improvement opportunities.
Act as qualified training for Quality Systems owned processes.


Process Ownership


The Quality Systems Senior Specialist will act as end-to-end Process Owner of one or more Quality Systems used within Global External Manufacturing.
Processes include Deviation Investigations, CAPA, complaints, change control, Quality Risk Management, Documentation, Training, Audits and Inspections and Supplier Management.
Own all elements of the process including relevant procedures/ forms, training materials, metrics where applicable
Display technical knowledge of the process and understand risks/weaknesses in the system
Be primary subject matter expert for review of regulatory or directive changes, responsible for coordination of input from key stakeholders into the impact assessment to the process


There will be 5% travel associated with this role.

Required Competencies and Desired competencies :


Works under minimum supervision and exhibits a positive work attitude and high productivity.
Detail-oriented, well organized and have excellent verbal and written communication skills as well as excellent organization and follow-up skills.
Candidate must be flexible and comfortable working in a fast-paced environment with aggressive and dynamic timelines.
Excellent interpersonal skills
Ability to collaborate, facilitate, and support standard practices across multiple functional groups in diverse geographical locations are required. Self-motivated
Strong presentation skills
Ability to multi-task numerous projects andachieve targets and milestones
Ability to recognize topics / decisions requiring escalation
Proficient in the use of Microsoft Office programs including OneNote and SharePoint platforms
A science related degree in Chemistry, Engineering or Biotechnology
A minimum of 7 years experience in a pharmaceutical Quality related role, preferably within a Quality Systems team.
A strong working knowledge of GxP regulations in the EU, US and other relevant global markets
Knowledge of OPEX tools
Experience in leading or participation in project teams


Desirable


Experience in a GxP Manufacturing site
Technical writing training / qualification
Lead investigator training
Qualified auditor
Lean Six Sigma qualification
Project Management qualification
Supervision of work of direct or indirect reports


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: R1527668_EN

Updated: 2020-07-16 00:00:00.000 UTC

Location: New Brunswick,New Jersey

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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