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Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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 resources to pursue their goals, both at work and in their personal lives. Read more about careers at BMS at careers.bms.com/working-with-us. Position Summary
This position is the lead responsible for the implementation and management of Bristol Myers Squibbs GMP Data Governance and Data Integrity programs at the Bothell, WA manufacturing facility. Duties/Responsibilities
Key Responsibilities Serve as the site data integrity (DI) subject matter expert (SME) and promote/train/coach site staff on ALCOA+ principles and associated worldwide regulations. Ensure site meets the Global BMS Data Integrity program expectations, including the annual DI Master Plan, DI training curriculum ownership, and launching DI related initiatives to promote the DI culture within the organization. Ensure validation, implementation and change management of e-systems used across the site operations comply with applicable regulatory requirements (FDA, EMA, etc.). Ensure systems at the Bothell site comply with data life cycle requirements from initial data creation/recording to archival and decommissioning, including data management, data security, data traceability process mapping, data backup/restore, electronic signatures/records linking, and data audit trails. Lead, review, and approve data integrity assessments for GxP systems and processes to ensure regulatory and internal DI requirements are met. Partner with cross-functional stakeholders to ensure systems and processes are DI compliant through governance and risk control; drive remediation actions when DI gaps are identified. Periodically report site DI metrics through the Site Quality Management Review and to the Global DI COE. Collaborate with the Global Data Integrity Center of Excellence to adhere to Global DI policies and strategy as defined by the BMS program. Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning. Reporting Relationship This position reports to the Sr Director Quality Systems and Compliance. Qualifications
Specific Knowledge, Skills, Abilities : Eight (8) or more years of relevant experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance roles. Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is preferred. Experience with QA oversight of e-systems for GMP operations is preferred. Demonstrated excellence in written and verbal communication; ability to work cross-functionally and maintain strong business partner relationships. Experience working with US FDA, EU and other regulatory agencies; substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and related standards. Demonstrated expertise in Data Integrity principles and GxP knowledge with ability to recognize DI risks and develop mitigation plans. Proven ability to drive continuous improvement and foster a compliant operational excellence culture. Proven leadership to make difficult decisions and lead teams in a matrixed environment; ability to influence members across functions. Experience using risk management tools (e.g., FMEA, FTA) to reduce risks through CAPA planning and implementation. Experience performing site and functional audits and walk-throughs. Education/Experience/Licenses/Certifications BS or higher in IT, engineering, scientific discipline or related field, or equivalent combination of experience and education. If you come across a role that intrigues you but doesnt perfectly line up with your resume, apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview
Bothell - WA - US: $142,550 - $172,741. The starting compensation range for a full-time employee is provided above. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary by job and location. For more on benefits, please visit careers.bms.com/life-at-bms/. Benefit offerings include medical, pharmacy, dental and vision care; wellbeing resources; financial well-being resources including 401(k); disability and life insurance; travel protection; paid holidays; vacation; volunteer days; sick time; flexible hours; parental, caregiver, bereavement, and military leave; family care services; tuition reimbursement; and a recognition program. Uniquely Interesting Work, Life-changing Careers
With a single vision to transform patients lives through science, every BMS employee plays an integral role in work that goes beyond ordinary. We are empowered to apply our talents and perspectives in a supportive culture, promoting global participation in clinical trials while upholding our values of passion, innovation, urgency, accountability, inclusion and integrity. On-site Protocol
BMS has an occupancy structure that determines where work is conducted: site-essential, site-by-design, field-based and remote-by-design roles. The assigned occupancy type is based on the roles responsibilities. Site-essential roles require 100% onsite shifts. Site-by-design roles may allow a hybrid model with at least 50% onsite. Onsite presence is considered essential for collaboration and productivity. Field-based and remote-by-design roles require ability to travel as needed. BMS provides reasonable accommodations and an accessible recruitment process. Applicants may request accommodations prior to accepting a job offer. For inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to view our EEO statement. BMS encourages vaccination as part of well-being and ongoing safety for employees, customers, patients, and communities. BMS will consider qualified applicants with arrest and conviction records, as required by law in your area. If you reside in Los Angeles County and are hired for this position, please visit the California residents page for additional information: careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr
Challenging. Meaningful. Life-changing. Those arent 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. Youll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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 resources to pursue their goals, both at work and in their personal lives. Read more about careers at BMS at careers.bms.com/working-with-us. Position Summary
This position is the lead responsible for the implementation and management of Bristol Myers Squibbs GMP Data Governance and Data Integrity programs at the Bothell, WA manufacturing facility. Duties/Responsibilities
Key Responsibilities Serve as the site data integrity (DI) subject matter expert (SME) and promote/train/coach site staff on ALCOA+ principles and associated worldwide regulations. Ensure site meets the Global BMS Data Integrity program expectations, including the annual DI Master Plan, DI training curriculum ownership, and launching DI related initiatives to promote the DI culture within the organization. Ensure validation, implementation and change management of e-systems used across the site operations comply with applicable regulatory requirements (FDA, EMA, etc.). Ensure systems at the Bothell site comply with data life cycle requirements from initial data creation/recording to archival and decommissioning, including data management, data security, data traceability process mapping, data backup/restore, electronic signatures/records linking, and data audit trails. Lead, review, and approve data integrity assessments for GxP systems and processes to ensure regulatory and internal DI requirements are met. Partner with cross-functional stakeholders to ensure systems and processes are DI compliant through governance and risk control; drive remediation actions when DI gaps are identified. Periodically report site DI metrics through the Site Quality Management Review and to the Global DI COE. Collaborate with the Global Data Integrity Center of Excellence to adhere to Global DI policies and strategy as defined by the BMS program. Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning. Reporting Relationship This position reports to the Sr Director Quality Systems and Compliance. Qualifications
Specific Knowledge, Skills, Abilities : Eight (8) or more years of relevant experience in pharmaceutical quality operations, quality assurance, quality systems, and/or IT compliance roles. Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is preferred. Experience with QA oversight of e-systems for GMP operations is preferred. Demonstrated excellence in written and verbal communication; ability to work cross-functionally and maintain strong business partner relationships. Experience working with US FDA, EU and other regulatory agencies; substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and related standards. Demonstrated expertise in Data Integrity principles and GxP knowledge with ability to recognize DI risks and develop mitigation plans. Proven ability to drive continuous improvement and foster a compliant operational excellence culture. Proven leadership to make difficult decisions and lead teams in a matrixed environment; ability to influence members across functions. Experience using risk management tools (e.g., FMEA, FTA) to reduce risks through CAPA planning and implementation. Experience performing site and functional audits and walk-throughs. Education/Experience/Licenses/Certifications BS or higher in IT, engineering, scientific discipline or related field, or equivalent combination of experience and education. If you come across a role that intrigues you but doesnt perfectly line up with your resume, apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview
Bothell - WA - US: $142,550 - $172,741. The starting compensation range for a full-time employee is provided above. Additional incentive cash and stock opportunities may be available based on eligibility. Final compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary by job and location. For more on benefits, please visit careers.bms.com/life-at-bms/. Benefit offerings include medical, pharmacy, dental and vision care; wellbeing resources; financial well-being resources including 401(k); disability and life insurance; travel protection; paid holidays; vacation; volunteer days; sick time; flexible hours; parental, caregiver, bereavement, and military leave; family care services; tuition reimbursement; and a recognition program. Uniquely Interesting Work, Life-changing Careers
With a single vision to transform patients lives through science, every BMS employee plays an integral role in work that goes beyond ordinary. We are empowered to apply our talents and perspectives in a supportive culture, promoting global participation in clinical trials while upholding our values of passion, innovation, urgency, accountability, inclusion and integrity. On-site Protocol
BMS has an occupancy structure that determines where work is conducted: site-essential, site-by-design, field-based and remote-by-design roles. The assigned occupancy type is based on the roles responsibilities. Site-essential roles require 100% onsite shifts. Site-by-design roles may allow a hybrid model with at least 50% onsite. Onsite presence is considered essential for collaboration and productivity. Field-based and remote-by-design roles require ability to travel as needed. BMS provides reasonable accommodations and an accessible recruitment process. Applicants may request accommodations prior to accepting a job offer. For inquiries, contact adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to view our EEO statement. BMS encourages vaccination as part of well-being and ongoing safety for employees, customers, patients, and communities. BMS will consider qualified applicants with arrest and conviction records, as required by law in your area. If you reside in Los Angeles County and are hired for this position, please visit the California residents page for additional information: careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. #J-18808-Ljbffr