Continuous Improvement Lead
About Bristol-Myers Squibb:
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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.
The role of Continuous Improvement Lead will report to the Director of Clinical Training, Process & Continuous Improvement who is a member of the Global Clinical Compliance & Continuous Improvement (GCC & CI) leadership team under Global Clinical Operations (GCO). Responsibilities will include:
- Collaborate with the Communications Lead to obtain insights from various functional stakeholders throughout GCO on process and system gaps. Identify, analyze and prioritize opportunities for improvements and develop plans for continuous improvement.
- Work closely with the Risk Management team and the Global Quality organization to support process improvement activities within the clinical Quality Management System (cQMS) oversight:
Analyze self-identified risks, audit and inspection findings and Corrective Action Preventive Action (CAPA) trends to determine and prioritize areas of improvement.
Generate periodic and ad hoc status reports on quality issues and events for trending and reporting.
Help develop and implement a Quality Improvement Plan to be reviewed and approved by the appropriate Quality and Compliance Governance.
- Propose the development of new, or modification of, core GCO processes in support of Clinical Trial execution in partnership with other GCO functions and key stakeholders. Develop a strategy and drive implementation of systematic and efficient After Action Reviews for key processes.
- Lead approved Continuous Improvement initiatives for GCO by engaging internal stakeholders at the right level, while being mindful of workload and related costs. Partner with other R&D functions and stakeholders as needed to ensure holistic approach of systemic issues that may impact areas other than GCO. Measure effectiveness of proposed changes in order to "fail safe, fail early".
- Serve as Subject Matter Expert and advisor to other GCO owners of continuous improvement initiatives, as needed.
- Work with management and Global Quality to foster a cross-functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset.
- A minimum of a Bachelor's Degree or equivalent is required. A degree in Life Sciences or equivalent is preferred. At least 5 years in the pharmaceutical industry and 2 years of experience in clinical trial operations and/or Good Clinical Practice is required.
- Robust understanding of the drug development process and clinical operations, experience in risk management, audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions.
- Lean Sigma qualification and experience in Project Management are preferred.
- Experience in matrix management is desirable with the ability to engage and inspire others. Good communication skills with a proven ability to effectively engage and manage key internal stakeholders in various functions and geographies. Good presentation and negotiation skills with the ability to timely resolve conflict in a constructive manner.
- Ability to manage multiple projects simultaneously to ensure timely, on-budget execution of tasks. Attention to detail with excellent planning, time management and organizational skills.
- The candidate will demonstrate the ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with speed, accountability and integrity, and to have fun along the way.