Senior Specialist, Manufacturing Compliance
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. The Senior Specialist, Manufacturing Compliance is responsible for serving as a key contributor in operational compliance on non-conformance events, investigations, batch record management, corrective and preventive actions (CAPA) and change management for the Warren Clinical Manufacturing Team DUTIES AND
Responsibilities:
Completing / reviewing routine manufacturing nonconformance / deviation investigations Reporting / monitoring metrics on non-conformance investigations, corrective and preventive actions Defining and implementing effective CAPAs to improve compliance and manufacturing success Representing the department in cross functional teams in support of process improvement initiatives Owning change controls and action items for changes impacting manufacturing as needed Ability to respond with a high degree of urgency to departmental and cross functional needs and requests Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports Executing revisions to master batch records / protocols / procedures, etc., as deemed necessary for process changes / improvements / new product introductions. Perform gap assessments and ensure compliance with current Data Integrity regulations, guidance, etc. Perform internal audits collaboratively with QA to ensure inspection readiness within facility. REQUIRED COMPETENCIES:
Education:
Bachelor's degree or higher in Life Sciences or engineering or equivalent in work experience. Master's degree preferred
Experience:
6-8
years of work experience in the pharmaceutical / biopharmaceutical industry required. Cell therapy experience a plus 4
years in a GMP setting 2
Years' experience with CAPAs, investigations, and/or change controls Knowledge, Skills, and Abilities:
Intermediate knowledge of GMP guidance and regulations, particularly those pertaining to GMP training, personnel, and documentation practices. Intermediate knowledge of quality systems including CAPA, change control, and document management systems. Advanced skills in using Microsoft Word, PowerPoint and Excel and a high level of organizational and time management skills. Capability of providing input within the department and cross functional teams Building relationships internally and externally as applicable Contributing to goals within the team and overall manufacturing operations structure Ability to prepare written communications to management with clarity and accuracy Ability to effectively multi-task and execute project management skills Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment. BMSCART VETERAN 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
Completing / reviewing routine manufacturing nonconformance / deviation investigations Reporting / monitoring metrics on non-conformance investigations, corrective and preventive actions Defining and implementing effective CAPAs to improve compliance and manufacturing success Representing the department in cross functional teams in support of process improvement initiatives Owning change controls and action items for changes impacting manufacturing as needed Ability to respond with a high degree of urgency to departmental and cross functional needs and requests Identifying and mitigating risks in manufacturing operations that could negatively impact delivery of safe and effective therapies to patients Reviewing and approving documents, including standard operating procedures, batch records, material specifications, and validation protocols / reports Executing revisions to master batch records / protocols / procedures, etc., as deemed necessary for process changes / improvements / new product introductions. Perform gap assessments and ensure compliance with current Data Integrity regulations, guidance, etc. Perform internal audits collaboratively with QA to ensure inspection readiness within facility. REQUIRED COMPETENCIES:
Education:
Bachelor's degree or higher in Life Sciences or engineering or equivalent in work experience. Master's degree preferred
Experience:
6-8
years of work experience in the pharmaceutical / biopharmaceutical industry required. Cell therapy experience a plus 4
years in a GMP setting 2
Years' experience with CAPAs, investigations, and/or change controls Knowledge, Skills, and Abilities:
Intermediate knowledge of GMP guidance and regulations, particularly those pertaining to GMP training, personnel, and documentation practices. Intermediate knowledge of quality systems including CAPA, change control, and document management systems. Advanced skills in using Microsoft Word, PowerPoint and Excel and a high level of organizational and time management skills. Capability of providing input within the department and cross functional teams Building relationships internally and externally as applicable Contributing to goals within the team and overall manufacturing operations structure Ability to prepare written communications to management with clarity and accuracy Ability to effectively multi-task and execute project management skills Superior attention to detail, organizational skills, and the ability to handle multiple tasks in a timeline-driven environment. BMSCART VETERAN 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. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Salary Range:
$80K -- $100K
Minimum Qualification
Industrial EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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