Senior Manager Quality Operations • Quality Operations, Bio/Sterile

Company : Bristol Myers Squibb

Job Type : Full Time

Boudry Ne

Number of Applicants

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000+

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Job Description - Senior Manager Quality Operations • Quality Operations, Bio/Sterile

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 . Responsibilities:
In collaboration with Responsible Person and Qualified Person perform product disposition activities to ensure the timely supply of drug substance, drug product, and finished biological products
Serve as a quality lead for the technical CMO projects related to commercial BMS product
Own or provide quality evaluation and approval of the change controls related to commercial biological products from CMOs
Provide quality decision on the deviations reported by CMOs for manufactured BMS products. Lead deviation meetings with CMOs.
Prepare and review of Quality Agreements with external and internal manufacturing and testing partners
Manage and report quality metrics in relation to CMO performance
Review and collaborate with CMO and BMS sites on Annual Product Quality Reviews as required for end-to-end product monitoring
Work with CMOs to ensure commercialization and PAI readiness for biological products introduced to CMOs
Review and approve analytical documentation in collaboration with the analytical SME
Provide quality operational support during self-inspections, internal audits, and regulatory agency inspections at contract manufacturers and BMS.
Support supplier relationship manager, global procurement, supply chain and manufacturing science and technology teams for the projects, technical transfers programs, supplier selection programs, and commercial manufacturing activities
Review validation documents, deviations, and change controls and escalate any potential compliance gaps
Escalate issues to senior management to ensure that issues are resolved to support BMS business and compliance requirements in a timely manner
Evaluate external quality complaint investigations provided by CMOs
Required Competencies:
Ability to assess the right balance between the business implications, technical considerations and quality decisions
Ability to set up and implement quality expectations for technical projects based on regulatory and industry standards
Ability to serve as a quality lead for technical projects
Strong negotiation, communication and presentation skills across all levels both internal and external to BMS
Demonstrated technical expertise in resolution of deviations, complaints, development of effective corrective and preventive actins (CAPA) and use of risk assessments
Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance, and great sense of urgency while assuring that all cGMP and regulatory requirements are met
Excellent verbal, written and presentation skills in English
Proficiency with the use of global systems (e.g. SAP, Microsoft Office).
Strong strategic and analytical thinking, problem solving and rapid decision making skills
Demonstrated capability in implementing challenging goals, objectives and practices in a complex and ambiguous environment
Confidence in negotiating and influencing without authority
Proficiency in technical writing
Desired Competencies:
Minimum B.S. degree in relevant scientific discipline e.g., Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science
Minimum of 6 years' experience in aseptic or sterile manufacturing operations at the manufacturing site (manufacturing department, quality assurance and release, or manufacturing science/technology)
At least 4 years in Quality Assurance, ideally in project management or product release
Experience in biological product manufacturing
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 . Visit careers.bms.com/ 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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