Quality Operations – External Manufacturing – QA Senior Specialist
vor 5 Monaten
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.
This position is responsible for Quality Assurance (QA), primarily with QA vendor oversight activities including the review of commercial bulk and finished drug products, deviation, complaint, and change control record management and providing a reliable source of information and accurate interpretation of quality, cGMP compliance requirements and quality systems, together with maintaining good working relationships with QA departments at contract facilities.
Note: Occasional travel may be required as part of this role
Responsibilities
Support Quality Operations Manager/Sr. Manager in the Contract Manufacturing Management in relation to quality assurance activities.
Ensure BMS products are manufactured, packaged, tested, released, and distributed in compliance with all regulatory and corporate requirements; this includes but is not limited to:
Building and maintaining a good working relationship with the contractor Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc. Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements. Manage change control requests. Process product complaints. Support the review of Annual Product Quality Review reports, as necessary. Participate in self inspections as appropriate Participate in external audits of contractor manufacturers and distributors as assigned Ensure quality metrics are always up to date, consistent and accessible to the Virtual Plant Team (VPT) Performance of trend reviews and compilation of metrics Support GMP/GDP site inspections, as assigned Maintain compliance with personal training requirements
Required Competencies
In depth knowledge of cGMP / GDP regulations pertinent to the USA, EU and other international markets Ability to assess the right balance between business targets and scientific and quality decisions Strong analytical and problem solving skills Ability to build relationships, partnerships and influence and/ or enforce quality decisions at external / internal sites as appropriate Good communication and organizational skills Project management skills Development, organization, and execution of the Pharmaceutical Quality System of BMS within the Global Quality Organization Must have computer proficiency
Required Qualification(s) and Desired Experience
MSc or equivalent in Bio-Science-Pharmaceutical disciplines. At least 5 years of experience in a pharmaceutical company (MS&T and Quality is preferred). Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development Direct experience interacting with Health Authorities and supporting Health Authority inspections, specifically FDA, EMA and/or Swissmedic Experience in interacting with external manufacturers and supporting quality at external manufacturing sites Business Fluent in English; French and German good proficiency is an asset. 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 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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