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Bristol Myers Squibb Global Process Lead - Validation & Tech Transfer in Devens, Massachusetts

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.

Major Duties:

Global Process Lead

  • In close collaboration with the Global Process Owner, serve as the process lead for a QMS process ensuring it remains in a state of control and is both effective and efficient

  • Supporting the process architecture of the integrated Quality Management System (QMS), lead a process workstream designed to monitor and improve said process(es) within the integrated GxP QMS framework

  • Work effectively across the matrix by engaging with the broader process owner network and local site or function process owners in designing and deploying QMS process improvements.

  • Identify and track progress against key project milestones partnering with applicable business, quality and other enabling functions and any external providers to ensure overall project success

  • Maintain global processes, procedures, and training materials in compliance with Global GxP requirements, BMS Global Quality Standards, and BMS’ Quality Management System (QMS) principles of integrated, patient-centric, and risk-based decision-making

  • Support deployment of global process by close cooperation with relevant functions and site/country leads

  • Provide training, support, and coaching as required

  • Define Community of Practice (COP), including roles, operating mechanisms, communication strategies, and levels of training and access

  • Provide data and input to drive other continuous improvement efforts across the enterprise as applicable, which may include priority and timing collaboration with other PLs

Pharma Validation Lead

  • Provide validation and technical direction to lead project teams as needed

  • Develop/review and approve validation protocols and final reports and ensure compliance with cGMPs and current regulatory requirements.

  • Define and guide sampling plans for new product launch and technical transfer between sites.

  • Coordinate and manage hold-time studies, cleaning studies, and revalidation/qualification activities for the site.

  • Drive best practices toward continued or continuous process validation (CPV)

  • Train colleagues in validation best practices and health authority expectations

  • Partner with development and development-to-launch teams for strategic alignment of cleaning studies, hold times, and revalidation/qualification activities for our manufacturing sites

  • Partner with manufacturing, QA, and technical transfer teams to resolve all deviations encountered during project and protocol execution.

  • Create and write validation protocols, directives, SOPs, and reports as required and review for technical validity.

  • Review change requests for impact to validation and support QA compliance activities such as Product Quality Review. Knowledge/Skill/Education:

  • Minimum Bachelors of Science/Engineering in a pharmaceutically relevant science or engineering discipline. Advanced degree (MS/M Eng/PhD) and/or PMP certification strongly preferred. Experience/Knowledge Desired:

  • Minimum 7 years work experience in different roles across the pharma industry related to validation, quality assurance, process and formulation development and technical transfer in development and manufacturing.

  • Thorough knowledge and understanding of validation requirements in a cGMP facility and Validation Lifecycle Approach.

  • Familiar with electronic quality system tools

  • Strong program and project management experience with proven track-record managing cross-functional programs and ability to manage

  • Thorough knowledge of cGMPs, ICH Q8, Q9, Q10, and FDA and pharmaceutical industry regulations and guidelines.

  • Competent in statistical analysis techniques required to understand process performance, sampling strategies, and quality acceptance standards.

  • Strong communication skills, including the ability to present to Sr. Management and global health authorities.

  • Demonstrated experience in building relationships and using influence. Can establish credibility and earns respect with a diverse set of internal and external stakeholders including manufacturing partners and other functional managers. Is able to “get things done” without compromising principles. A high level of energy and strong work ethic is critical to success.

  • Excellent interpersonal, collaborative, team building, and communication skills to ensure effective collaborations within matrix teams. Demonstrated performance against cooperation principles and enterprise mindset.

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: R1531961-en-us-1

Updated: 2020-11-28 03:09:24.018 UTC

Location: Devens,Massachusetts

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.