Manager, Risk Management Facilitator

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.

MAJOR DUTIES AND RESPONSIBILITIES

• Co - leads the Quality Risk Management Program (QRMP)for our operations.

• Develop Risk Management Plan (RMP) for the site. Execute corresponding risk assessments of this plan and ensure completion as per timeline.

• Execute corresponding Risk Assessment (RA) of the RMP and others leading a multi-disciplinary team and coaching for others

• Execute RA using tools such as PHA, FTA, FMEA and recommend ways to control or reduce risk.

• Manage workload of RMP and develop RA reports and obtained the required approval

• Facilitate identified RA related to Change Control, QE and others.

• Ensure Risk Register Maintenance and CAPA generation based on RA results

• Communicate QRMP results in the Quality Council.

• Process Improvement & Cost Avoidance

• Monitors effectiveness of QRM knowledge transfer programs and makes needed corrections.

• Analyze site key performance indicators and business metrics and propose alternatives for improvement

• Submits and approves risk assessments, change requests and procedures.

• Conducts and approve risk assessments for compliance documents and critical tasks.

• Evaluates and approve compliance documents in official document management system.

• Educate areas in Quality Risk Management and other technical topics such as Decision Making and Root Cause Analysis among others.

• Works with the site areas to update QRM requirements specifically based on the needs of functional areas (Warehouse, QC, Manufacturing, Engineering, Maintenance, and Supply Chain, Manufacturing Technology).

QUALIFICATIONS

• Bachelor’s Degree in Science (Microbiology, Chemistry, Engineering or Pharmacy), Business Administration, Industrial Organizational Psychology or Education

• Five (5) years of experience in the Pharmaceutical industry and (3) years of experience in the risk management area and/or a similar function within the Pharmaceutical industry.

• Strong knowledge in in Risk Assessment tools such PFMEA, FTA, Root Cause Analysis Knowledge of manufacturing processes such as: solid dosage, aseptic filling, cleaning, packaging and inspection,

• Knowledge and ability to develop risk assessments

• Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems related to potential risks.

• Knowledge of cGMP’s, Safety and Environmental regulations

• Excellent Presentation/delivery training Skills

• Proficient knowledge of Computerized programs (Microsoft Office including Word, Power Point, Excel and etc.)

• Knowledge of GMP’s, FDA Regulations, documentation practices and manufacturing process

• Experience working with manufacturing documents, change controls and regulatory

• Fully Bilingual (English and Spanish) written and oral

• Excellent interpersonal skills required

• Willing to work irregular hours, rotated shifts, weekends and holidays

BMSBL

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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