Associate Director, CTF Digital Plant IT Quality

2 days ago

Fort Devens, United States Bristol-Myers Squibb Full time
Job Summary

Bristol-Myers Squibb is seeking an experienced Associate Director to lead the Digital Plant IT Quality team at our Devens Cell Therapy Facility (CTF). This role will be responsible for directing the development, implementation, and maintenance of IT/Automation processes and ensuring adherence to System Life Cycle standards.

Key Responsibilities
  • Lead the IT Compliance, IT Deviation Management Program, Computer System Audit Program, Change Management, Risk Management Program, and Computer System Validation Program at the Devens CTF.
  • Direct a high-performing Digital Plant Quality team by effectively managing team culture, skills, performance management, goal-setting, coaching, people development, priorities, and workload for the Digital Plant Compliance and Computer System Validation teams.
  • Collaborate with the Digital Plant Leadership Team to drive the department vision, quality strategy, goals, and culture.
  • Provide mentorship and leadership influence at all levels of the organization, including within Digital Plant, Quality, Validation, MS&T, and Manufacturing Operations teams.
  • Influence internal and external stakeholders to ensure operational decisions and business requirements have a positive impact on Digital Plant and BMS.
Requirements
  • Thorough knowledge of regulatory computer system validation requirements, including FDA, EMA, and Worldwide Regulatory requirements.
  • Demonstrated knowledge of Quality principles and QA methodologies, including GAMP and ISO 9001.
  • Mastery of site and global SOPs, cGMPs, compliance requirements, regulatory guidelines, and technical acumen to work and manage within a regulated environment.
  • Proven experience in designing and implementing quality systems, risk management systems, audit readiness programs, deviation management programs, change management, and program elements required to manage the system lifecycle of a fully automated, multi-product, Cell Therapy manufacturing facility.
  • Demonstrated competency required to represent the department before stakeholders, external regulatory agencies, and management.
Education and Experience
  • Engineering and science experience generally attained through studies resulting in a B.S. in Engineering, a related IT/OT discipline, or its equivalent.
  • Experience managing high-performing teams.
  • Experience leading Compliance and Computer System Validation (CSV) projects.
  • A minimum of 8 years of relevant experience in the biopharmaceutical industry or its equivalent.
Working Conditions

Work within Site Facilities, which requires a high attention to detail and on occasion to properly use Personal Protective Equipment (PPE). May work on cross-site or enterprise initiatives to drive policy.

  • Associate Director, CTF Digital Plant IT Quality Lead

    2 days ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking an experienced Associate Director, CTF Digital Plant IT Quality to join our team.About the RoleThe Associate Director, CTF Digital Plant IT Quality will be responsible for directing...

  • Associate Director, Supplier Quality and Audits

    19 hours ago

    Fort Devens, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Associate Director, Supplier Quality and Audits to join our team.About the RoleThis is a critical role that will support the external supplier audit...

  • Director of Quality Operations

    3 weeks ago

    Devens, Massachusetts, United States Veranova L P Full time

    Job Title: Director of Quality OperationsVeranova L P is seeking a highly skilled Director of Quality Operations to lead the coordination and planning for the Quality Operations function and Quality Control test labs for the site.Key Responsibilities:Develop and implement the Quality Operations & Quality Control strategy at the site.Create QC/QA workload...

  • Digital Media Director

    2 days ago

    Fort Worth, Texas, United States KADA Inc Full time

    Job Title: Associate Director Digital MediaAt KADA Inc, we are seeking a highly skilled and experienced Associate Director Digital Media to join our team. This role will play a key part in establishing and optimizing our digital media processes, driving digital strategy, and managing and developing talent.Key Responsibilities:Collaborate with the Account...

  • Quality Assurance Lead

    4 weeks ago

    Fort Devens, United States Omni Inclusive Full time

    Job DescriptionOmni Inclusive is seeking a highly skilled Quality Assurance Lead to join our team in Devens, MA. As a key member of our Technical Operations team, you will be responsible for providing quality assurance support to our site and reporting manager through quality review and approval of investigations and corrective actions.Key...

  • Quality Assurance Lead

    2 days ago

    Fort Devens, United States Omni Inclusive Full time

    Job Title: QA Lead Technical Operations, ProjectsOmni Inclusive is seeking a highly skilled QA Lead Technical Operations, Projects to join our team.Job Summary:We are looking for a seasoned Quality Assurance professional to lead our Technical Operations, Projects team. The successful candidate will be responsible for providing quality assurance support to...

  • Digital Content Director

    3 weeks ago

    Fort Lauderdale, Florida, United States Nmble Full time

    Director of Digital ContentNmble is seeking a seasoned Director to lead our digital content strategy and execution. This role requires a strong background in retail CPG and experience in creating innovative content for digital advertising channels.Key Responsibilities:Develop and implement a comprehensive digital content strategy that drives engagement and...

  • Director, IT Business Partner, Cell Therapy Development

    3 weeks ago

    Devens, Massachusetts, United States Bristol-Myers Squibb Full time

    Transforming Patients' Lives through ScienceBristol-Myers Squibb is a leading pharmaceutical company dedicated to transforming patients' lives through science. We are seeking a highly skilled and experienced Director, IT Business Partner, Cell Therapy Development & Operations (CTDO) Quality to join our team.About the RoleThe successful candidate will be...

  • Digital Marketing Director

    3 weeks ago

    Fort Lauderdale, Florida, United States Boys & Girls Clubs of Broward County Full time

    Job Title: Director of Digital MarketingWe are seeking a highly skilled and experienced Director of Digital Marketing to join our team at Boys & Girls Clubs of Broward County. The successful candidate will be responsible for developing and executing a comprehensive digital marketing strategy that drives engagement, increases brand awareness, and supports our...

  • Digital Content Director

    4 weeks ago

    Fort Lauderdale, Florida, United States Nmble Full time

    Director of Digital ContentNmble is seeking a seasoned Director to lead our digital content strategy and execution. This is an onsite position with remote Fridays.Key Responsibilities:Develop and implement innovative content across various digital advertising channels.Drive D2C and ecommerce initiativesLead a team with strength in leadership and...

  • Digital Marketing Director

    5 days ago

    Fort Lauderdale, Florida, United States Inter Miami CF Full time

    Job Title: Director, Digital MarketingWe are seeking a highly skilled and strategic Director of Digital Marketing to lead our club's digital initiatives and drive digital growth, fan engagement, and revenue generation.About UsInter Miami CF is a professional soccer team based in Miami, Florida. We are committed to creating a unique and exciting fan...

  • Digital Media Director

    3 weeks ago

    Fort Wayne, Indiana, United States Deploy Alloy Full time

    About the JobThe Digital Media Director is a key leadership role responsible for overseeing and implementing digital media strategies for Deploy Alloy. This role involves managing and optimizing various digital media channels to drive brand awareness, engagement, and conversions.Key Responsibilities:Digital Media StrategyCollaborate with the Director of...

  • Digital Media Director

    2 days ago

    Fort Wayne, Indiana, United States Deploy Alloy Full time

    About the JobThe Digital Media Director is a key leadership role responsible for overseeing and implementing digital media strategies for Deploy Alloy. This position involves managing and optimizing various digital media channels to drive brand awareness, engagement, and conversions.Key Responsibilities:Digital Media StrategyCollaborate with the Director of...

  • Director of Quality Operations

    3 weeks ago

    Devens, Massachusetts, United States Veranova Full time

    Job SummaryThis role leads the coordination and planning for the Quality Operations function and Quality Control test labs for the site, in collaboration with site leadership, to assure the day-to-day Quality Assurance aspects of manufacturing, issue resolution, and batch disposition of active pharmaceutical ingredients, intermediates, or other special...

  • Digital Account Director

    13 hours ago

    Fort Worth, Texas, United States LHH Recruitment Solutions Full time

    Job Title: Digital Account DirectorLHH Recruitment Solutions is seeking a Digital Account Director to join our team in the Fort Worth, TX area. As a key member of our client's team, you will be responsible for managing digital marketing campaigns and building strong relationships with clients.Key Responsibilities:Manage digital marketing campaigns to meet...

  • Director, Quality Operations

    4 weeks ago

    Devens, United States Veranova L P Full time

    Job DescriptionJob DescriptionCompany DescriptionVeranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Job SummaryThis position...

  • Director, Quality Operations

    3 weeks ago

    Devens, United States Veranova Full time

    Company Description Veranova is a global leader in the development and manufacturing of complex active pharmaceutical ingredients (APIs) for pharma and biotech customers. With deep technical expertise and impressive flexibility, we develop solutions and processes that support and accelerate innovation. Job Summary This position leads the coordination and...

  • Senior Director, Quality Control Operations

    2 weeks ago

    Fort Devens, United States Bristol-Myers Squibb Full time

    Job SummaryWe are seeking a highly experienced Senior Director, QC Operations to lead our Quality Control Operations organization and oversee QC Analytical, QC Microbiology, and QC Systems activities. This role will be responsible for ensuring efficient and high-quality release of product to cell therapy patients.Key ResponsibilitiesProvide senior leadership...

  • Quality Assurance Lead Technical Operations

    2 weeks ago

    Devens, Massachusetts, United States Sunrise Systems Full time

    Job Title: QA Lead Technical Operations, ProjectsJob ID: 24-02756Location: Devens, MADuration: 03 Months contract on W2Job Description/Responsibilities:As a Quality Assurance Lead Technical Operations, you will provide quality assurance support to the Devens Site and reporting manager through quality review and approval of investigations and corrective...

  • Digital Account Director

    2 days ago

    Fort Worth, Texas, United States LHH Recruitment Solutions Full time

    Job Title: Digital Account DirectorLHH Recruitment Solutions is seeking a highly skilled Digital Account Director to join our team. As a key member of our client services team, you will be responsible for leading digital marketing campaigns and building strong relationships with our clients.Responsibilities:Develop and execute comprehensive digital marketing...