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.
- Responsible for the Event Management processes (deviations, lab investigations, product complaints, CAPA) and adherence to applicable GMP regulations, BMS policies and procedures for CT globally.
- Lead the development, implementation and harmonization of Event Management processes across Cell Therapy.
- Develop and direct effective quality assurance oversight of the product complaint program inclusive of review/approval of complaints, complaint trending program, resolution of confirmed complaints, investigations and CAPA
- Acts as champion of continuous improvement and works cross-functionally to ensure that quality systems processes are compliant and harmonized across CT Development, Ops, Quality, Franchise for events management – investigations, CAPA, product complaints
- Act as Cell Therapy Quality liaison with Global Process Owners and Global Quality Systems team for strategy development and implementation of new initiatives and improvements to the existing systems and programs.
- Provide expertise and guidance in interpreting global governmental regulations, agency guidelines and internal procedures related to event management processes to assure continued compliance across all Cell Therapy GMP operations.
- Oversee trending of quality systems and operational KPIs across the Cell Therapy; advise on mitigation of unfavorable trends.
- In partnership with the Cell Therapy Operations & Quality network, establish and drive continuous improvement of the investigations, CAPA, and product complaints programs.
- Drive strong collaboration within the Cell Therapy Investigations Community of Practice
- Build, develop and sustain a talented team with the required skills and knowledge to ensure investigation, CAPA and complaint processes are conducted in accordance with Bristol Myers Squibb policies, standards, procedures and Global cGMP.
- Ensure long-term success by proactively addressing any anticipated investigational process challenges identified across Cell Therapy internal and external manufacturing network.
- Influence across the organization to establish a culture of excellence and right-first-time execution.
- Establish and utilize Quality performance metrics and ensure the creation of appropriate and effective risk-based remediation.
- Stay current with industry trends and BMS standards and participate in best practice forums consistent with function responsibilities.
- Contribute to and support network teams which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of facilities and products
- Define and enforce performance measures, provide developmental feedback and coaching, and create a collaborative environment
Qualifications and Education Requirements
- Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is required
- A minimum of 10 years’ experience in biopharmaceutical operations with 4+ years of prior management experience
- Strong background and demonstrated effectiveness in quality systems.
- Knowledge of cell therapy, analytical testing or biotech bulk and finished product manufacturing is highly desirable.
- Knowledge of US and EU cGMP regulations and guidance.
- Knowledge and proven experience in FDA, EMA, or other regulatory authority.
- Demonstrated leadership, interpersonal, communication, and motivation skills.
- Experience with investigations, root cause analysis and implementation of effective corrective and preventative actions
- Experience in product complaints and/or documents used in regulatory filings is a plus
- Experience in building and growing an organization into a high-performance team.
- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, 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 medium level issues.
- Routinely recognizes Quality issues and solves problems.
- Able to prepare written communications and communicate problems to management with clarity and accuracy.
- Able to effectively multi-task.
Devens - MA – US, Summit – NJ – US, Seattle – WA - US
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 email@example.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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