Bristol-Myers Squibb Company

Quality Optimization Lead, Internal Sites

Location
New Brunswick, NJ, US
Posted
Jan 16, 2019
Ref
R1513176
Required Education
Bachelors Degree
Position Type
Full time
The Quality Optimization Lead, Internal Sites (QOL) position supports the Head of Internal Sites Quality on the operations management and is responsible to (i) to be the primary point of a contact for Internal Sites on the MSQ Network Quality and/or Network QC strategy execution elements and provides strategic input to ensure projects enable value to be delivered as planned. (ii) advance and harmonize the Quality/ Compliance Excellence and other continuous improvement strategies across the internal sites of the network as per objectives. (iii) ensures appropriate transparency exists to drive Quality Operations Excellence for Internal Sites (iv) provides Quality Leadership for Network Optimization efforts, involving current or future internal assets in Bio & Pharma.

This position will be the primary delegate of the Head of ISQ, is based in New Brunswick and requires ~25% travel

Duties
  • Establish, report and run the Internal Sites Quality Operations Monthly Review to ensure the proper transparency and escalation of Internal Sites Quality Operations, Compliance Performance, Network QA and Network QC Projects occurs.
  • Monitor quality and compliance for internal sites, through the established quality metrics and ensures there is continued alignment with BMS Tiered Quality Council Governance model, Global Quality Performance Management Organization and Operations Management Organization in the establishment, revision, reporting of metrics and/or escalation of issues.
  • Support the Head of Internal Sites Quality, in the generation of any required Tier 2 Quality Council data analysis, escalation or reporting, ensuring integration and collaboration with other areas across Global Quality.
  • Provide leadership and influence a dynamic and diverse staff of Quality professionals across the network, to ensure the sites develop, plan and monitor Quality/ Compliance Excellence, and continuous improvement strategies as per objectives.
  • Lead at the above site level QC and QA operational excellence initiatives of internal sites to ensure transformational changes occur to drive Quality Operations competitive advantage.
  • Support best practices sharing /knowledge management across the network including linkages to EXM, provide a space for external focus, and support bringing in market practices/benchmark.
  • Act as a single point of contact for Internal Sites with the Network Quality Lead and the Network QC Lead. In this capacity, liaise with the Network Quality and Network QC Lead to understand all network quality strategic projects affecting the sites and ensures these projects are properly communicated, planned, chartered and executed at the site level.
  • Provide Quality Leadership for GPS Network Optimization efforts, involving current or future internal assets in Bio & Pharma, in conjunction with the Head of Internal Sites Quality and in collaboration with other stakeholders.
  • In providing Quality Leadership, collaborate with other members of the MSQ and across GQ organization and seek concurrence while dealing with complex issues. Use critical analysis and develop ethical, risk-based solutions to meet both business and regulatory requirements.
  • Coordinates and/or provides SME input to for BMS Policies, Directives, SOPs related to quality compliance when required.
  • Leads communication and develops effective strategies & partnership with stakeholders from MSQ, OPEX, Supply Chain, Regulatory, Project Management, and Operations.


Education

Advanced degree in science of pharmaceutical related fields (Chem, Pham, Bio, Chem Eng) preferred.

Experience / Knowledge
  • Understanding of technical areas related to pharmaceutical and/or biological manufacturing, chemical and/or biochemical analyses, microbiological analyses, statistical methods, regulatory and quality control/quality assurance processes.
  • Mastery of Quality compliance processes and regulations, e.g., cGMP/GDP regulations.
  • A thorough understanding of company policies and regulatory requirements, and their relation to the management and documentation of product quality investigations.
  • Familiar with electronic quality systems tools
  • A minimum of 10 years of experience in quality operations
  • A minimum of 15 years of experience in pharmaceutical operations


Skills and Competences
  • Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
  • Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole
  • Excellent influencing and negotiating experience and capabilities in a matrix environment. Must be able to interact with senior leaders in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on Head of Quality for Internal Sites behalf and interface with stakeholders in a matrix environment.
  • Uses judgment to make sound decisions based on information gathered and analyzed.
  • Ability to build strong, trusting relationships, lead large/complex programs, and work across divisions, diverse business backgrounds and cultures.
  • Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness.
  • Has a proven track record of delivering results and is action oriented.
  • Completes work in a timely and consistent manner.
  • Adapts to changing work environments, work priorities and organizational needs.
  • Plans and organizes tasks and work responsibilities to achieve objectives. Sets priorities. Schedules activities.
  • Organizes and delivers information appropriately.