Sr Manager Manufacturing Site IT

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.

Bristol Myers Squibb is a global biopharmaceutical company committed to transforming patients’ lives through science. At the core of that mission are the talented individuals who contribute their “unique” skillsets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we’re looking for talented professionals like you to join our team. What unique gene will you bring?

PURPOSE AND SCOPE OF POSITION:

This position is responsible for the planning, implementation, and support of IT site systems supporting the Quality Control and Commercial Manufacturing Cell Therapy functions in Bothell, WA. This role will be responsible for system ownership, inspection readiness, data integrity, and IT support.

REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:


Bachelor’s degree or equivalent in work experience.

10 years’ experience Master’s Degree preferred

Demonstrated ability to lead teams that deliver and support digital capabilities for Quality Control and Commercial manufacturing.

Demonstrated ability to communicate, influence and partner with functional business leaders.

Strong knowledge of current good manufacturing/ Commercial process (GxP), particularly as it relates to IT (21 CFR Part 11, Data Integrity, Computer Systems Validation, etc).

Manufacturing and Lab system implementation experience.


DUTIES AND RESPONSIBILITIES:


Provide technical leadership to support the successful delivery of Quality Control (QC) and Commercial Manufacturing IT systems for Cell Therapy site.

Partner with Cell Therapy QC and Commercial Manufacturing stakeholders to identify and roadmap future business needs as well as solution technical requirements.

Partner with business user groups on purchases and implementation of technology/tools new to Cell Therapies. Engineer solutions which improve data sharing, data security, analysis, and overall data integrity.

Demonstrate matrix leadership of IT resources in other IT functions including architecture, infrastructure, project management as well as vendor & business subject matter experts.

Provide technical direction for site and enterprise system implementations and releases. This includes but is not limited to initial strategy and approach, implementation, validation, end user and administrator training, and go-live support.

Partner with site Quality on inspection readiness and audit activities.

Provide oversight to site IT quality management. (Audit actions, CAPA’s, Deviations, Periodic Monitoring reviews, etc.)

Acts as owner for Site IT Systems quality documents such as Deviations, CAPAs, and Change Controls.

Authors Deviation Investigations, CAPAs, SOPs, work instructions and training materials as needed to support IT systems

Improves business processes for system documentation

Help facilitate Deviation Investigation


Preferred Experience and Skills:


Knowledge of cGMP regulations and FDA guidance applicable to computerized systems, electronic records and signatures.

Experience acting as release analyst, project coordinator or document specialist preferred.

Understanding of S88 and S95 architecture

SDLC, Deviation, CAPA, Change Control, Release Management and Support services management

Demonstrated understanding and experience with process validation methodologies, willingness to work as a team player in a change-oriented department

Proven ability to understand business goals and recommend new approaches to effect continual improvements in business objectives.

The ability to manage multiple priorities simultaneously, have a strong drive - orientated on results

Strong analytical skills and ability to provide data-based insights and observations

Passion for innovative and process improvement

Detail oriented with excellent verbal and written communication skills

Desire to grow and take on increased scope of responsibility


WORKING CONDITIONS (US Only):

General office environment working conditions. Some lifting and transport of equipment (up to 25 lbs). Majority of time is seated in office.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

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.

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