Bristol Myers Squibb
Overview
Sr Manager Data Integrity role at Bristol Myers Squibb, Bothell, WA. Lead the implementation and management of the GMP Data Governance and Data Integrity programs at the Bothell manufacturing facility. This position reports into the Sr Director Quality Systems and Compliance. Duties/Responsibilities
Key Responsibilities: Serve as the site 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 the validation, implementation and change management of e-systems used across the site operations are conducted in compliance with applicable Data Integrity regulatory requirements (FDA, EMA, etc). Responsible for ensuring 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, 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 DI compliance through governance and risk control, and drive remediation when DI gaps are identified. Periodically report Data Integrity metrics of the site through the Site Quality Management Review and to the Global DI COE. Collaborate with BMS Global Data Integrity Center of Excellence to align with Global DI policies and strategy. Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning. Reporting Relationship
This position reports into the Sr Director Quality Systems and Compliance. Qualifications
Specific Knowledge, Skills, Abilities Eight (8) or more years of relevant work 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 and ability to work cross-functionally. Experience with US FDA, EU and other regulatory agencies; knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and related standards. Demonstrated Data Integrity principles and GxP knowledge with ability to recognize DI risks and develop mitigation plans. Proven leadership in decision-making within a matrixed environment and in driving continuous improvement and compliant operational excellence. Experience utilizing 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. Compensation & Benefits
Bothell, WA: $142,550 - $172,741. The starting compensation range is for a full-time employee and may include incentive cash and stock opportunities based on eligibility. Final compensation will be based on experience. Benefits vary by location and may include medical, dental, vision, 401(k), life insurance, disability, EAP, paid holidays, vacation, volunteer days, and other programs. For more details, visit careers.bms.com/life-at-bms/. Additional Information
BMS is committed to equal employment opportunities and inclusive workplace accommodations. If you require reasonable accommodations in completing this application or during recruitment, contact adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for the full EEO statement. Vaccination guidance and other legal disclosures may apply depending on location.
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Sr Manager Data Integrity role at Bristol Myers Squibb, Bothell, WA. Lead the implementation and management of the GMP Data Governance and Data Integrity programs at the Bothell manufacturing facility. This position reports into the Sr Director Quality Systems and Compliance. Duties/Responsibilities
Key Responsibilities: Serve as the site 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 the validation, implementation and change management of e-systems used across the site operations are conducted in compliance with applicable Data Integrity regulatory requirements (FDA, EMA, etc). Responsible for ensuring 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, 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 DI compliance through governance and risk control, and drive remediation when DI gaps are identified. Periodically report Data Integrity metrics of the site through the Site Quality Management Review and to the Global DI COE. Collaborate with BMS Global Data Integrity Center of Excellence to align with Global DI policies and strategy. Prepare and deliver communications to site leadership regarding risk, mitigations, data integrity metrics, and Global DI Program planning. Reporting Relationship
This position reports into the Sr Director Quality Systems and Compliance. Qualifications
Specific Knowledge, Skills, Abilities Eight (8) or more years of relevant work 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 and ability to work cross-functionally. Experience with US FDA, EU and other regulatory agencies; knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and related standards. Demonstrated Data Integrity principles and GxP knowledge with ability to recognize DI risks and develop mitigation plans. Proven leadership in decision-making within a matrixed environment and in driving continuous improvement and compliant operational excellence. Experience utilizing 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. Compensation & Benefits
Bothell, WA: $142,550 - $172,741. The starting compensation range is for a full-time employee and may include incentive cash and stock opportunities based on eligibility. Final compensation will be based on experience. Benefits vary by location and may include medical, dental, vision, 401(k), life insurance, disability, EAP, paid holidays, vacation, volunteer days, and other programs. For more details, visit careers.bms.com/life-at-bms/. Additional Information
BMS is committed to equal employment opportunities and inclusive workplace accommodations. If you require reasonable accommodations in completing this application or during recruitment, contact adastaffingsupport@bms.com. See careers.bms.com/eeo-accessibility for the full EEO statement. Vaccination guidance and other legal disclosures may apply depending on location.
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