QA Deviation Reviewer, Approver Senior Specialist (R1559054-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
- Must have advanced knowledge and experience with cGMP manufacturing, Quality, and Compliance.
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Must have strong authorship and be able to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
- Must be able to note technical/scientific attributes in potential situations or issues and process science-based solutions across most of the job function.
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
- Must provide guidance to other employees in the interpretation of technical/scientific issues across a majority of the job function and manage development of technical or scientific initiatives and activities by interdisciplinary teams.
- Must be action-oriented and customer-focused, building relationships, problem solving, planning and organizing, conflict management, resource allocation, coaching other and analytical thinking.
- Must possess an independent mindset and tenacity.
- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision. Work is self-directed.
- Confident in making decisions for minor issues.
- Routinely recognizes Quality issues and solves problems.
- Proposes solutions for complex issues and works with management to resolve.
- Follows established procedures and performs work as assigned.
- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
- Ability to interpret results and situations and articulate recommendations for resolution.
- Is recognized Subject Matter Expert within the group.
- Capable of providing input within the department and cross functional teams.
- Provides guidance to other employees in interpretation of complex data.
- Builds relationships internally within and with cross functional teams.
- Able to recognize conflict and notify management with proposed recommendations for resolution
- Contributes to goals within the work group.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to write and review reports with clarity and brevity.
- Thorough knowledge of and competence in quality processes, including but not limited to material disposition, deviations, investigations, and CAPA management.
- Able to effectively multi-task and execute project management skills.
- Knowledge of US and global cGMP requirements.
- Understanding of aseptic manufacturing processes.
- Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
- Excellent verbal and written communication skills.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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