Job Information
Bristol Myers Squibb Senior Manager, Quality Control in Aichi, Japan
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 rich in diversity. 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 .
Senior Manager, Quality Control (QC) - Aichi, Japan
Position Summary: Bristol Myers Squibb is seeking a highly skilled and experienced Senior Manager to lead our Quality Control (QC) team in Aichi, Japan. As the Head of QC at our Aichi laboratory, you will play a critical role in ensuring the quality and safety of our pharmaceutical products through rigorous testing of small molecule and biological medicines. This position oversees a broad scope of activities, including release and stability testing of locally manufactured products, import testing, raw material inspection, environmental monitoring, and microbiology. The role is essential in maintaining compliance with Japan's cGMP standards, Bristol Myers Squibb's internal quality standards, and supply chain demands.
Key Responsibilities:
Lead and manage the QC organization at the Aichi laboratory, overseeing the testing and inspection of raw materials, bulk and final drug products, environmental monitoring, microbiology, and stability.
Ensure all analyses meet current Japanese Good Manufacturing Practice (cGMP) standards and BMS quality standards, supporting timely product release and ensuring supply chain efficiency.
Support Quality Operations and In-Market Quality teams by providing accurate and timely test results for product release decisions.
Maintain strong connections within the global QC network to align the Aichi laboratory as a key part of BMS's overall analytical testing strategy.
Contribute to the development and execution of the network's analytical strategy, ensuring its successful deployment at the Aichi site.
Lead a talented and growing QC team, fostering a culture of safety, continuous improvement and high performance.
Collaborate with Japan stakeholders, including GQP, CMC, and regulatory bodies (e.g., PMDA), to provide analytical support and address regulatory inquiries.
Proactively manage analytical issues.
Qualifications
Bachelor's or master's degree (MSc) in analytical chemistry, biochemistry, pharmacy, or related fields, a PhD in the same disciplines is plus.
7-10 years of experience in pharmaceutical manufacturing, quality control, or quality assurance, along with sufficient knowledge to assume the role.
Knowledge and thorough understanding of ICH, PICS, Japanese and international cGMP.
Advanced leadership and people management skills.
Change Agent.
Problem solving mindset and sense of urgency.
Requires strategic thinking and ability to work in a matrix environment.
Ability to interpret/write general, technical, and complex business documents.
Advanced presentation skills.
Able to write, read, and speak English fluently
Why Join Us? At Bristol Myers Squibb, you will be a part of a diverse and global QC organization that is dedicated to delivering innovative medicines that help patients prevail over serious diseases. As a leader in the QC team, you will play a pivotal role in ensuring the safety and quality of life-saving therapies distributed across Japan, while having the opportunity to develop and grow alongside a world-class team.
Apply Today! Join us in making a difference in the lives of patients. Apply now to become a part of our dynamic team at Bristol Myers Squibb.
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 an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse 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. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. 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: https://careers.bms.com/california-residents/
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Company: Bristol-Myers Squibb
Req Number: R1586002
Updated: 2024-10-04 03:11:07.604 UTC
Location: Aichi-JP
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.