Bristol Myers Squibb Quality Operations Manager in United States
Provide quality and compliance oversight to Contract Manufacturing Organizations (CMOs) engaged by Biologics External Manufacturing (BEM) operating in a cross functional virtual plant team.Represent BEM Quality on project teams for GMS compliance projects providing BEM input and leadership
Work with CMO as the BEM Quality point of contact for technical tranfer activities between BMS and CMO
Perform gap assessments and risk assessments on DP/FP manufacturing processes and analytical methods as part of technical transfers to CMO from BMS.
Review, approve technical transfer and PPQ Qualification protocols and reports
Review and approve deviations from protocols
Establish testing lab relationship and CoA expectations
Perform assessments for incoming raw materials/drug substance (cryogenic expectations) with CMO and BMS SMEs
Perform product disposition activities which are aligned with BMS operations functions to ensure the timely supply of drug substance and drug product that meets commercial customer requirements while ensuring compliance with testing standards, SOPs, validation guidelines and regulatory filings.
Provide quality/compliance subject matter expertise to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MS&T teams in support of new projects and technical transfers programs,
Evaluate CMOs by performing Supplier Risk Assessments
Assist with quality projects for revised quality systems, harmonized procedures, new CMOs
Provide support for change controls, deviation, and complaint activities
Escalate issues to BEM Senior Management to ensure that issues are resolved to support BMS business and compliance requirements.
Assist with compiling the quality metrics for CMO performance and GDP Management review activities
Assist with or lead OpEx projects related to BEMQ business processes.
Demonstrate proficiency in interpretation of FDA EMA and Rest of World cGMP and EU Good Distribution Practice (GDP) regulations for biologics drug substance and drug product manufacture, testing and distribution, medical device and packaging. Participate on technical transfers and quality related projects. Consistently demonstrate the required BMS Core Behaviors of accountability, passion, speed, and innovation.
BMS BioPharma Behaviors required
Passion: We pursue excellence to help patients prevail. I set high standards for myself and others to win for our patients / I energize others / I strive to learn something new every day / I treat my patients, customers and colleagues with compassion, empathy and respect.
Innovation: We embrace new ideas. I challenge the status quo / I seek and share bold idea that help BMS win / I pursue and understand diverse perspectives outside of BMS / I encourage and have constructive debates / I embrace change to drive innovative outcomes / I rebound quickly and learn from my mistakes.
Accountability: We own our outcomes and the outcomes of others. I own BMS? Success by holding myself and others accountable / I share information in a transparent and honest way / I celebrate my successes and the successes of others / I coach and mentor others with good intent and purpose / I am inclusive and bring out the best in others / I understand what people do and the impact I have on them.
Speed: We act with urgency and agility. I work with a sense of urgency / I focus on what’s important / I consult with the right people to move quickly / I seek efficient, effective solutions / I quickly assess potential risks and rewards / I break silos and eliminate unnecessary rules / I make decisions with resolve and enable others to do the same.
We’re creating innovative medicines for patients fighting serious diseases. We’re also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled