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Bristol Myers Squibb
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Bothell, Washington
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/working-with-us .
The IT Quality & Compliance Manager works cross-functionally to lead compliance ... contributor but may manage supporting contract resources periodically. The IT Quality & Compliance Manager
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Bristol Myers Squibb
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Seattle, Washington
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. The Principal PQL supports efforts to establish collaborations between Regulatory Affairs, Process ... regulatory compliance of GMP operations in support of the assigned program. This role can be stationed
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Bristol Myers Squibb
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Bothell, Washington
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regulatory officials, demonstrating credible and substantial QC laboratory expertise.
Identifies and ... material testing is performed in compliance with regulatory agencies, cGMPs, and other company policies and
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Bristol Myers Squibb
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Bothell, Washington
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System.
Support internal and external audits and regulatory inspections and audits.
Support corporate and site-level requests for compliance and regulatory data.
Represent the Quality unit at
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Bristol Myers Squibb
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Bothell, Washington
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/working-with-us .
Position Summary
The Senior Manager, Validation, Engineering and ... . The Senior Manager oversees the Right to Operate, Operational Excellence and Ongoing Monitoring area
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Bristol Myers Squibb
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Bothell, Washington
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. Actively supports regulatory inspections.
Interact with global and site teams including Process
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Bristol Myers Squibb
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Bothell, Washington
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’s no better place than here at BMS with our Cell Therapy team.
Our Manager, Quality ... regulatory inspection data and trending issued by regulatory authorities to ensure proactive compliance
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Bristol Myers Squibb
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Bothell, Washington
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additional site-based technical documentation and activities. The Manager, QEV is an individual contributor ... and industry / regulatory expectations related to GxP controls and system releases before, during and
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Bristol Myers Squibb
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Bothell, Washington
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validation. Stay abreast of industry trends, advancements, and regulatory changes – especially related to
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Bristol Myers Squibb
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Bothell, Washington
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external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory
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Bristol Myers Squibb
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Seattle, Washington
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activities for the pipeline and supports late stage portfolio for regulatory, translational development and ... , regulatory interactions and label negotiations
Proven ability to work with global disease teams to
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Bristol Myers Squibb
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Bothell, Washington
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support routine clinical and commercial production to ensure consistent compliance with regulatory and
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Bristol Myers Squibb
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Seattle, Washington
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and regulatory guidelines
Understanding of scientific publications
Clinical trial ... , governmental, and regulatory requirements.
Understands treatment paradigms, competitive landscape and
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Bristol Myers Squibb
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Bothell, Washington
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department in regulatory inspections (internal and external audits).
Train and mentor others on multiple ... completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
Demonstrated
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