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Sr Manager Data Integrity - Bothell, WA
On-site role at Bothell, WA. The position leads Bristol Myers Squibb’s GMP Data Governance and Data Integrity programs at the Bothell facility.
Job Description Position summary and responsibilities focus on implementing and managing data integrity programs, systems, and governance to ensure compliance with regulatory requirements across site operations.
Responsibilities
Serve as the site DI (Data Integrity) subject matter expert (SME) and promote/train site staff on ALCOA+ principles and related worldwide regulations.
Ensure the site meets the Global BMS Data Integrity program expectations, including the annual DI Master Plan, DI training curriculum ownership, and DI-related initiatives to foster a DI culture.
Oversee validation, implementation, and change management of e-systems used across site operations in compliance with DI regulatory requirements (FDA, EMA, etc.).
Ensure data life cycle compliance from creation/recording to archival and decommissioning, including data management, data security, traceability, 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.
Collaborate with cross-functional stakeholders to ensure DI compliance of systems and processes through governance and risk control; drive mitigation/remediation for DI gaps.
Periodically report site Data Integrity metrics through Site Quality Management Review and to the Global DI COE.
Coordinate with the Global Data Integrity Center of Excellence to ensure alignment 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 This position reports to the Sr Director Quality Systems and Compliance.
Qualifications
Eight (8) or more years of relevant experience in pharmaceutical quality operations, quality assurance, quality systems, or IT compliance.
Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems (preferred).
Experience with QA oversight of e-systems for GMP operations (preferred).
Strong written and verbal communication; ability to work cross-functionally and build strong business partnerships.
Experience collaborating with US FDA, EU, and other regulatory agencies; substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO standards.
Demonstrated Data Integrity expertise and GxP knowledge with risk identification and mitigation planning.
Proven leadership and ability to drive continuous improvement and foster a compliant operational excellence culture.
Experience using risk management tools (e.g., FMEA, FTA) to mitigate risks via CAPA. Experience performing site and functional audits and walk-throughs.
BS or higher in IT, engineering, science or related field, or equivalent combination of education and experience.
Compensation and Location Bothell, WA – US: $142,550 - $172,741. Additional incentive cash and stock opportunities may be available. Final compensation determined based on experience.
Additional Details
Employee type: Full-time
Affiliate Sponsor: Bristol Myers Squibb (BMS)
Industry: Pharmaceutical / Quality Systems
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Job Description Position summary and responsibilities focus on implementing and managing data integrity programs, systems, and governance to ensure compliance with regulatory requirements across site operations.
Responsibilities
Serve as the site DI (Data Integrity) subject matter expert (SME) and promote/train site staff on ALCOA+ principles and related worldwide regulations.
Ensure the site meets the Global BMS Data Integrity program expectations, including the annual DI Master Plan, DI training curriculum ownership, and DI-related initiatives to foster a DI culture.
Oversee validation, implementation, and change management of e-systems used across site operations in compliance with DI regulatory requirements (FDA, EMA, etc.).
Ensure data life cycle compliance from creation/recording to archival and decommissioning, including data management, data security, traceability, 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.
Collaborate with cross-functional stakeholders to ensure DI compliance of systems and processes through governance and risk control; drive mitigation/remediation for DI gaps.
Periodically report site Data Integrity metrics through Site Quality Management Review and to the Global DI COE.
Coordinate with the Global Data Integrity Center of Excellence to ensure alignment 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 This position reports to the Sr Director Quality Systems and Compliance.
Qualifications
Eight (8) or more years of relevant experience in pharmaceutical quality operations, quality assurance, quality systems, or IT compliance.
Expertise with 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems (preferred).
Experience with QA oversight of e-systems for GMP operations (preferred).
Strong written and verbal communication; ability to work cross-functionally and build strong business partnerships.
Experience collaborating with US FDA, EU, and other regulatory agencies; substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO standards.
Demonstrated Data Integrity expertise and GxP knowledge with risk identification and mitigation planning.
Proven leadership and ability to drive continuous improvement and foster a compliant operational excellence culture.
Experience using risk management tools (e.g., FMEA, FTA) to mitigate risks via CAPA. Experience performing site and functional audits and walk-throughs.
BS or higher in IT, engineering, science or related field, or equivalent combination of education and experience.
Compensation and Location Bothell, WA – US: $142,550 - $172,741. Additional incentive cash and stock opportunities may be available. Final compensation determined based on experience.
Additional Details
Employee type: Full-time
Affiliate Sponsor: Bristol Myers Squibb (BMS)
Industry: Pharmaceutical / Quality Systems
#J-18808-Ljbffr