Bristol Myers Squibb - Associate Director - Product & Supply Quality Excellence

Working with Us.

• Challenging.
• Meaningful.
• Life-changing.
• Those aren't words that are usually associated with a job.
• But working at Bristol Myers Squibb is anything but usual.
• Here, uniquely interesting work happens every day, in every department.
• From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.
• You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams.
• Take your career farther than you thought possible.
• 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.
• Read more : careers.bms.com / working-with-us .
• Provide strategy, oversight and leadership in support of the APQR run the business activities including document authoring, coordination of review and comments resolution, approval, for both site and End to End APQRs.
• Ensure execution and performance of run the business and strategic initiatives associated to APQR's continuously improve to meet compliance needs and business priorities.
• Support health and performance of APQR program in compliance with procedural guidelines and requirements.
• Ensure on time execution of the APQR program in accordance with the published schedule.
• Manage stakeholder needs in balance to priorities and execution of the APQR program, through management of the APQR team.
• Manage events associated to findings of compliance gaps, inspectional observations and deviation from global processes.
• Liaison with the business as the subject-matter expert to ensure accurate APQR content and compliance with health authority regulations and expectations and BMS procedures.
• Provide leadership and coaching in relation to contemporary knowledge of current industry trends, standards, and methodologies as it relates to APQR.
• Manage risk and uncertainty, and to anticipate the need for and implement contingency plans to ensure on time delivery of APQR documents.
• Provide strategy, oversight and leadership in support of the APMC run the business activities including regulatory filing and change control reference data updates, master data maintenance, and data reviews / approvals for products released in SAP Batch Release Hub.
• Lead team to meet goals while resolving complex issues.
• Develop, adjust, and monitor key performance indicators to identify and mitigate risk to business objectives.
• Monitor trends to develop continuous improvement objectives and revised contingency plans (as required).
• Collect metrics to identify trends and take appropriate action.
• Communicate up to date status to impacted business & Demonstrated quality leadership, organization, and communication skills.
• Ability to lead a team in a global matrix environment.
• Understanding of Biologics, Pharmaceutical, and / or Cell Therapy operations and processes, preferred.
• Experience in a GMP Quality role required.
• Working knowledge of conducting and compiling APQRs.
• Prior experience with navigating multiple Quality Management systems.
• Experience with commercial change control processes.
• Demonstrated tactical thinking capability with strong project management skills and ability to focus on execution of strategic decisions.
• Ability to build strong relationships across the organization by being transparent, reliable, and delivering on commitments.
• Ability to provide innovative ideas, align and make decisions balancing speed, quality, and Minimum of a Bachelor's degree in a Natural Science, Pharmacy, Engineering, or other Healthcare-related field.
• Minimum 10+ years of experience in a technical, quality, and / or regulatory role within the biopharmaceutical industry with demonstrated leadership in Quality Compliance or Operations preferred.
• Minimum 2 + years of people management experience.
• Requires availability during core US and EU hours.
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking, including the ability to deliver clear and articulate presentations.
• If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.
• You could be one step away from work that will transform your life and career.
• Uniquely Interesting Work, Life-changing Careers.
• With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary.
• Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our BMS has an occupancy structure that determines where an employee is required to conduct their work.
• This structure includes site-essential, site-by-design, field-based and remote-by-design jobs.
• The occupancy type that you are assigned is determined by the nature and responsibilities of your role : .
• Site-essential roles require 100% of shifts onsite at your assigned facility.
• Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility.
• For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture.
• For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
• BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles.
• Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer.
• As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
• BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
• If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information : Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

(ref : iimjobs.com)