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    Senior Manager, Business Operations Performance, Training Compliance and Documentation - New Brunswick, NJ, United States - Bristol-Myers Squibb

    Bristol-Myers Squibb
    Bristol-Myers Squibb New Brunswick, NJ, United States

    3 weeks ago

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    Description
    Working with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

    From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

    You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

    Take your career farther than you thought possible.
    Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

    We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.


    Read more:
    position is responsible for developing, operationalizing, and monitoring a training, learning, and documentation management system that is appropriate for Drug Product Development (DPD) organization. The position has shared responsibility for the retention of DPD's documentation and knowledge. Scope includes GMP and non-GMP procedures, guidance, and other key documents related to the drug development process and technologies. The position also develops and makes visible performance metrics for DPD organization and drives a culture of compliance in alignment with DPD's goals and objectives.


    Responsibilities:


    Key member of a dynamic scientifically driven team, dedicated to the integration of innovation and technology in the development of drug products.

    Responsible for developing, executing, and monitoring strategy for training, learning, and ownership of drug product development practices, procedures, and guidance documents.

    Responsible for determining applicability of Pharmaceutical Development and BMS company-level training for DPD in collaboration with key stakeholders.

    Collaborate with key stakeholders to drive DPD's participation in key company-based initiatives (i.e., Quality Management System, BMS Documentation system, implementation of innovative technologies, etc).Participate with key DPD stakeholders to enable knowledge retention in appropriate systems.

    Collaborate with area management to develop and manage personnel training plans in alignment with employees' functional role.
    Serves as primary point of contact for site functional areas regarding training and compliance related activities.

    Measure performance related to DPD (including training and compliance), proactively make visible informative metrics that enable compliance and decisions and drive a culture of compliance.

    Implement and manage a phase appropriate GMP training program to ensure compliance with relevant regulatory requirements for pharmaceuticals and devices.

    Build and maintain effective training programs and role-based curricula for DPD that range from new hire onboarding to training for job-specific responsibilities.

    Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals.
    Serve as a resource of scientific and technical expertise.
    Assume departmental responsibilities for assigned projects.


    Required:
    Degree in Chemical Engineering, Pharmaceutics, Chemistry or Material Science, or a relevant scientific disciplinePh.
    D. and minimum of 4 years of relevant experienceM.S. and minimum of 6 years of relevant experienceB.S. and minimum of 8 years of relevant experiencePrior experience with devices in pharmaceutical development preferred.


    Skills/Knowledge Desired:
    Strong background in pharmaceutical development as it relates to formulation development and process development/optimization.

    Demonstrated knowledge of application of cGXPs during pharmaceutical product developmentDemonstrated proficiency in balancing resource requirements within projects and among multiple assigned projects.

    Strong interpersonal skills and the ability to work in a fast paced, multidisciplinary environment.
    Ability to work independently or lead scientifically on cross functional assignments. Strong verbal and written communication skills are essential.
    Displays strong project management and analytical skills with the ability to support development and implementation of strategic plans.
    Strong demonstrated negotiation and influencing skills.

    If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway.

    You could be one step away from work that will transform your life and career.

    Uniquely Interesting Work, Life-changing CareersWith a single vision as inspiring as "Transforming patients' lives through science ", every BMS employee plays an integral role in work that goes far beyond ordinary.

    Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    On-site ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles.

    Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

    If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to Visit to access our complete Equal Employment Opportunity statement.

    BMS cares about your well-being and the well-being of our staff, customers, patients, and communities.

    As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.

    BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

    Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

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