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Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Manager, QC Systems and Support

Validation, Compliance & Quality SystemsPosted on Nov 9
Full-timeLeiden, NetherlandsNo salary listed

About the Job

Requirements

  • Ability to accurately and completely understand, follow, interpret, and apply global regulatory and current Good Manufacturing Practice requirements.
  • Ability to work collaboratively in a fast-paced team environment, meet deadlines, and prioritize work across multiple activities.
  • Advanced problem-solving ability, technical aptitude, logical reasoning, and attention to detail.
  • Ability to apply Lean, Six Sigma, and Risk Management concepts and tools; these are preferred.
  • A bachelor's degree or equivalent is required, preferably in science; an advanced degree is preferred.
  • Six to eight or more years of relevant laboratory work experience, preferably in a regulated environment. An equivalent combination of education and experience may substitute for two or more years of experience within a regulated environment.
  • Two or more years of leadership experience are required.
  • Demonstrated experience with processes and techniques such as sample management, incoming goods control, and laboratory work.
  • Working knowledge of quality management systems and implementation of data integrity principles.
  • Advanced knowledge of computerized systems and enterprise applications such as SAP and LIMS.

Responsibilities

  • Provide direct management of the QC Systems and Support team and oversee daily activities.
  • Develop and execute a team work plan, ensure safety, quality, and performance targets are achieved, and track, trend, and report key performance metrics.
  • Author, review, and approve records and technical documents to ensure results comply with requirements, corporate guidelines, and regulations.
  • Own and evaluate relevant change controls, investigations, deviations, and corrective and preventive actions.
  • Hire, coach, mentor, and develop team members to support business operations and employee career development, and resolve personnel conflicts in the workplace.
  • Lead team meetings and cross-functional operational meetings, and act as a point of contact and technical advisor for work in the assigned area.
  • Communicate effectively, including escalating and cascading critical information to support effective business operations.
  • Provide performance evaluations and support the development of direct reports.
  • Ensure employees are properly trained and qualified to perform assigned tasks.
  • Identify and mitigate risks that could negatively affect laboratory operations, safety, or compliance.
  • Lead team resources in designing, implementing, and continuously improving Quality Control systems.
  • Apply technical knowledge and scientific principles to troubleshoot and solve non-routine and complex issues.
  • Ensure the responsible area or process remains inspection-ready and support internal and external inspections.
  • Perform other tasks as required to support the QC laboratories.

Desired Qualifications

  • Ability to apply Lean, Six Sigma, and Risk Management concepts and tools.
  • Laboratory work experience in a regulated environment is preferred.
  • Bachelor's degree preferably in science; an advanced degree is preferred.

About the Company

Bristol Myers Squibb

Makes drugs for cancer, blood and immune diseases

Bristol Myers Squibb discovers, develops and sells prescription medicines for serious illnesses, including cancer, blood disorders, immune diseases and heart disease, for patients treated by doctors and hospitals around the world. Its best-known drug is Opdivo, an immunotherapy that helps the body's own immune system find and attack many kinds of cancer. Researchers develop drug candidates in its labs or bring them in through acquisitions and partnerships, then test them in clinical trials to win regulatory approval. The company makes and markets the approved medicines and earns its revenue from sales of patent-protected drugs. Its roots go back to a business founded in 1887, and it is based in Lawrence Township, New Jersey.

Company size
10,001+
Company stage
IPO
Headquarters
Lawrence Township, NJ
Founded
1887

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