Quality Services Senior Specialist EXM Americas

Profile

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.

Summary:

The Quality Services Senior Specialist 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 Services 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 Services owned processes.

Process Ownership

The Quality Services 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 and achieve 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

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.

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, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com