Bristol-Myers Squibb Company

OpEx Lead Quality

Location
Devens, MA, US
Posted
Oct 11, 2018
Ref
R1509052
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time
OpEx Lead - Quality

Description

At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.

Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world's leading BioPharma companies.

We've created one of the world's premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus - a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.

Reporting to the OpEx Site lead, provides operational excellence support to activities in the Quality function that will increase customer service, reduce operating cost and improve general cycle times.

Summary

To develop, implement and manage operational strategies for multi-product operations that provides increase efficiency, improve data availability for decision making and drive continuous improvement within the Devens Quality Unit.

Major Duties and Responsibilities:

- Provide operational excellence support to activities in the Quality function that will increase customer service, reduce operating cost and improve general cycle times.

- Drive tiered meeting and visual factory for Quality team, aligned with site approach.

- Collaborate with site and department functions to develop required pertinent metrics for Quality to drive performance.

- Collaborate with Quality team to drive project portfolio following positive NPV/ROI, ensuring cost/benefit analysis to assess the impact or viability of alternate processes or action.

- Collaborates with OpEx practitioners in the Network. Participates as needed in Kaizen events and other OpEx initiatives in the Biologics network.

- Act as primary point of contact for Quality OpEx. Effectively partner with site OpEx lead and SMT to develop routine integrated messages on the OpEx program, highlight results/business benefits delivered from OpEx projects, new program offerings/trainings etc. to all personnel via multiple media including posters, newsletters, Web, public forums etc.

- Lead and/or support key complex projects through effective project management and leadership.

- Achieve high customer satisfaction through effective communication of both technical and nontechnical topics with all levels of the organization both verbally and in writing.

CONTACTS

The Quality OpEx lead will work directly with interdisciplinary cross functional team and key stakeholders within the Quality organization as well as regular interactions with other departments supporting site manufacturing processes.

WORKING CONDITIONS

Work is performed in a business office with periodic access to a state-of-the-art large scale cell culture facility with classified areas in which one has potential exposure to hazardous materials and requires the appropriate use of Personal Protection Equipment.

DECISION MAKING

Take action, final decision, recommend

May work on assignments that are extremely complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations. Accountable for delivery of results. Erroneous decisions or failure to achieve results may have financial implications or cause delays in schedules.

The incumbent will make decision and recommendations that have measurable dollar impact on business processes, waste reduction and resulting business benefits. Projects with impact to significant business process changes will be prioritized. Code of Federal Regulations, cGMPs, Facility Inspection Response, Division Policies and facility specific SOPs, Job Aids and developed project plans provide the basic guidelines and authority limits for handling decisions. Division policies and department SOPs are based on FDA regulations and good business practices. Prioritize all efforts for OpEx initiatives for Quality.

SUPERVISION RECEIVED

Incumbent acts independently to determine methods and procedures on new assignments. Receives assignments in the form of objectives and establishes goals to meet objectives. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to senior management, recommending and implementing corrective actions.

SUPERVISION EXERCISED

Individual contributor

The above statements are intended to describe the general nature of work being performed by people assigned to these roles. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Knowledge and Skills:

- Knowledge of engineering and/or science normally attained through studies resulting in a Bachelor's Degree in Science, Engineering, a related discipline or its equivalent.

- A minimum of 8 years GMP Biopharmaceutical QA/QC experience with strong experience with laboratory operations is preferred.

- Demonstrates a strong knowledge of cGMP compliance and regulatory agency requirements and procedures.

- Lean Master training certification is strongly preferred.

- Excellent computer skills with proficient in Microsoft applications- SharePoint, Project, PowerPoint, Access, Excel, Word, Publisher, Visio.

- Excellence in business change management processes and strong project management skills is needed

- Successful experience working with cross-functional project teams from manufacturing, quality, engineering, MS&T, tech services, automation, finance, PMO, OPEX, documentation control, and regulatory. Working knowledge (implementation knowledge preferred) of Laboratory Operations, Laboratory Information Systems, Documentation/Training and Quality Assurance processes.

- Excellent verbal and written communication skills.

- Strong communication/presentation skills with ability to tailor the message to the key stakeholders for effective impact and influence.

- Complete varied and complex assignments with little direction. Ability to integrate their work with that of other functions with strategic objectives.

- Interpersonal/facilitation skills necessary to interface with and influence all levels of the organization with the ability to lead people and multi-disciplinary teams.

- Comfortable managing in a matrix organization.

- Ability to be flexible and adapt quickly to changing needs of the organization.

- Ability to organize multiple work assignment and establish priorities.