Bristol Myers Squibb
Senior Manager Quality Systems, Site Data Integrity Lead in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Manager Quality Systems, Site Data Integrity Lead in Devens, MA
Location: Devens, MA. 3 days ago Be among the first 25 applicants. The Senior Manager Quality Systems, Site Data Integrity Lead is responsible for ownership and oversight of the Data Integrity (DI) Program at Devens Cell Therapy. The Site Data Integrity lead will be accountable for designing and delivering a strategic vision for compliance deliverables, risk management, gap remediation, continuous improvement, and quality culture across the site related to Data Integrity standards. The ability to work cross-functionally with all levels of the organization, be an exceptional communicator, and influence without direct authority will be essential for driving best in class Data Integrity performance for Devens Cell Therapy. Responsibilities
Establish, monitor, report, and drive action focused DI performance metrics for Site Management Review (Quality Council). Lead cross-functional DI Quality Governance Forum. Drive continuous improvement and strategic quality maturity planning. Oversee site DI Champions program. Own the site DI Master Plan. Lead associated annual remediation strategy/goal setting. Deliver front room support for Health Authority Inspections and drive site DI Inspection Readiness solutions. Oversee Data Integrity Risk Assessment (DIRA) program and lead role for FMEA facilitation. Collaborate with Network teams on bringing next-gen DI solutions to site. Establish best in class DI Culture through designing and delivering DI training solutions across all levels at the site. Perform and advise on DI Impact Assessments for potential high-risk deviations, change controls, and process risk assessments. Align quality objectives for site Data Integrity with other quality systems (Deviation, CAPA, Change Management, Risk Management, etc.) to drive adoption of DI best practices in daily operations across all departments. Maintain knowledge of evolving regulatory expectations related to Artificial Intelligence (AI) and operate as SME on application of BMS AI procedures and requirements for use in GMP manufacturing procedures. Knowledge and Skills
Demonstrated ability to drive strategic innovation, measurable process improvements, and deliver to expedited project deadlines. Experience with Health Authority inspections and interacting with regulatory bodies within the biotech industry. Strong knowledge of cGMPs and domestic regulatory requirements pertaining to Quality Systems and Quality Risk Management (ICH Q10 and ICH Q9). Strong interpersonal skills with the ability to drive dynamic changes through collaboration with cross functional stakeholders. Basic Requirements
Bachelor’s degree, preferably in a life science field; advanced degree preferred. Preferred minimum 8 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment within biotech, cell therapy or pharmaceuticals. Preferred minimum 4+ years of quality system experience or diversity of experiences leading quality focused initiatives. Compensation and benefits information is provided on the official careers site and varies by location.
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Location: Devens, MA. 3 days ago Be among the first 25 applicants. The Senior Manager Quality Systems, Site Data Integrity Lead is responsible for ownership and oversight of the Data Integrity (DI) Program at Devens Cell Therapy. The Site Data Integrity lead will be accountable for designing and delivering a strategic vision for compliance deliverables, risk management, gap remediation, continuous improvement, and quality culture across the site related to Data Integrity standards. The ability to work cross-functionally with all levels of the organization, be an exceptional communicator, and influence without direct authority will be essential for driving best in class Data Integrity performance for Devens Cell Therapy. Responsibilities
Establish, monitor, report, and drive action focused DI performance metrics for Site Management Review (Quality Council). Lead cross-functional DI Quality Governance Forum. Drive continuous improvement and strategic quality maturity planning. Oversee site DI Champions program. Own the site DI Master Plan. Lead associated annual remediation strategy/goal setting. Deliver front room support for Health Authority Inspections and drive site DI Inspection Readiness solutions. Oversee Data Integrity Risk Assessment (DIRA) program and lead role for FMEA facilitation. Collaborate with Network teams on bringing next-gen DI solutions to site. Establish best in class DI Culture through designing and delivering DI training solutions across all levels at the site. Perform and advise on DI Impact Assessments for potential high-risk deviations, change controls, and process risk assessments. Align quality objectives for site Data Integrity with other quality systems (Deviation, CAPA, Change Management, Risk Management, etc.) to drive adoption of DI best practices in daily operations across all departments. Maintain knowledge of evolving regulatory expectations related to Artificial Intelligence (AI) and operate as SME on application of BMS AI procedures and requirements for use in GMP manufacturing procedures. Knowledge and Skills
Demonstrated ability to drive strategic innovation, measurable process improvements, and deliver to expedited project deadlines. Experience with Health Authority inspections and interacting with regulatory bodies within the biotech industry. Strong knowledge of cGMPs and domestic regulatory requirements pertaining to Quality Systems and Quality Risk Management (ICH Q10 and ICH Q9). Strong interpersonal skills with the ability to drive dynamic changes through collaboration with cross functional stakeholders. Basic Requirements
Bachelor’s degree, preferably in a life science field; advanced degree preferred. Preferred minimum 8 years of relevant Quality or Manufacturing experience in a GMP/FDA regulated environment within biotech, cell therapy or pharmaceuticals. Preferred minimum 4+ years of quality system experience or diversity of experiences leading quality focused initiatives. Compensation and benefits information is provided on the official careers site and varies by location.
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