Senior Manager, QC Analytical Tech Support

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Working with Us
Challenging. 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: careers.bms.com/working-with-us.

In this role you will lead the Analytical Tech Support team within the Quality Control (QC) department. This position will develop strategic plans and work cross-functionally to accomplish acquisition, qualification and lifecycle support of QC equipment and analytical instrument, including Business Owner accountabilities for QC computer systems. You will be responsible for cGMP compliance of the laboratory area and operations under your responsibility as well as for applying and ensuring staff complies with Environmental Health & Safety applicable procedures. The Sr. Manager QC Analytical Tech Support reports to the Director Head of Quality Control.

Key Responsibilities
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Manage team and ensures cGMP compliance of the laboratory area and operations under their responsibility.

• Create a positive and collaborative team environment and or ensure that Bristol Myers Squibb standards are met.
• Manages performance and provides technical guidance, coaching and support to team members.
• Assigns training requirements and monitors training status of assigned team members.
• Ensures all equipment used for GMP testing is installed and qualified in compliance with regulations.
• Approve equipment and instrument deviations as SME/Area Manager.
• Authors, reviews, and approves complex GMP documentation such as laboratory procedures, work practices, plans, protocols, and reports.
• Support and sustains Lean Lab initiatives such as 5S, deviation reduction, Right First Time, Gembas and inspection readiness.
• Actively participates in inspections by Health Authorities.
• Create metrics to monitor schedule progress and help identify risk areas.
• Supports budget definition and ensure adherence to budget target.
• Create team plans to ensure resources are properly allocated and utilized effectively.
• Represent QC in cross-functional meetings as assigned.

  Oversee QC Analytical Instrument, Equipment and Computer System acquisition, qualification, and ongoing performance.

  • Work cross-functionally to assure timely acquisition and introduction of instrument, equipment, and computer systems into QC
  • Support Head of QC on CAPEX planning.
  • Coordinate with Project Management Office, Site and Network Stakeholders to ensure that QC computer system and equipment-related projects are adequately managed, resourced, and supported.
  • Ensure creation and adherence to Validation Master Plan for QC Equipment and Instruments
  • Ensure Business Owner accountabilities for applicable QC computer systems are maintained throughout the system lifecycle.
  • Ensure laboratory computer systems are administered, custom calculations are verified, and risk-based audit trail reviews are established and timely performed in accordance with the requirements of the stage of the system/method lifecycle.
  • Ensure system ongoing performance issues are adequately supported, investigated and corrective and preventive actions implemented.
  • Approve qualification protocols and reports.

    Data risk assessment

    • Actively facilitate or participate on the development data integrity risk assessments (DIRAs) for QC processes and systems.
    • Approve DIRAs as appropriate.
    • Collaborate cross-functionally to define risks mitigation strategy and monitor progress against schedule.

      Support QC Commercial Drug Product and Incoming Material Teams

      • Provide technical support to QC team members.
      • Support to identify training gaps and development of training content.
      • Work with QC leadership to identify and procure equipment.

        Promotes safe practices and behaviors.

        • Report immediately incidents to Environmental Health and Safety (EHS) department, participate in investigations and identify measures to prevent similar accidents in the future.
        • Ensures that staff (including short duration and temporary contracts) is properly informed on hazards and trained to act in consequence.
        • Promotes safe practices and behaviors, assure that EHS requirements are implemented and respected.
        • Demonstrate Bristol Myers Squibb values.

          Qualifications & Experience
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          Education and Experience

          • BS or advanced ?degree in Chemistry, Biochemistry, Pharmacy, or relevant scientific discipline or equivalent combination of education, training and experience.
          • Minimum 8 years of work experience in a GMP environment (pharmaceutical industry or similar field) or 5+ years with advanced degrees.
          • Quality area (e.g. Quality Assurance, Quality Control, Quality System) management experience preferred.
          • Practical knowledge of Quality Systems and regulatory requirements (21 CRF Part 11/210/211), EU Guidelines on Good Manufacturing Practice.
          • Knowledge of FDA Data Integrity and Compliance with Drug CGMP Guidance, EU GMP Annex 15: Qualification and Validation, US Pharmacopeia 1058 Analytical Instrument Qualification and GAMP 5 Guidance for Computer System Validation.
          • Scientific and practical knowledge of analytical techniques (e.g., chromatography techniques (High-performance liquid chromatography, Ultra-performance liquid chromatography, Gas chromatography), Dissolution, UV/VIS, and IR techniques).
          • Exceptional experience with chemistry testing of solid oral dosage forms.
          • Extensive knowledge on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production.

            Required Competencies:? Knowledge, Skills, and Abilities

            • Knowledge of Data Integrity and Good Documentation Practices.
            • Ability to accurately understand, follow, interpret, and apply European Pharmacopeia and United States Pharmacopeia requirements and cGMP requirements.
            • Exceptional technical writing skills.
            • Work to improve efficiencies through process improvements.
            • Exceptional critical thinking and demonstrate troubleshooting and problem-solving skills.
            • Independent, adaptable, and highly motivated.
            • Action-oriented and capable of setting priorities, managing timelines, and effectively managing changing priorities.
            • Understand how to collaborate with a variety of different people and roles.
            • Communicate effectively with direct reports, peers, and management.
            • General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio).
            • Fluent in English or French and professional command of the second language (written and verbal).

              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 Careers
              With 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 Protocol
              Physical 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 Write an email. Visit careers.bms.com/eeo-accessibility 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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