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In oncology, hematology, immunology and cardiovascular disease — and one of the most diverse and promising pipelines in the industry — each of our passionate colleagues contribute to innovations that drive meaningful change.
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We bring a human touch to every treatment we pioneer. Join us and make a difference. Associate Director, Quality Shared Services The Associate Director Quality Shared Services directs the development, implementation and refinement of standards, methods, procedures, quality systems, and daily operations for sample management in support of release and stability testing, data evaluation and reporting in support of method trending, APQR, and quality metrics, lab equipment and instrument lifecycle ownership, and lab investigations and deviations in accordance with cGMP and Company SOPs.
Responsibilities: Direct the daily operation of a Quality Shared Services department responsible to support cross-functional activities within Quality Control and Quality Assurance related to sample management, operations support, and equipment lifecycle.
Direct programs or procedures which assure the proper qualification, calibration, operation and maintenance of laboratory equipment, the timely data analysis and reporting of trends and the completion of written investigations in response to unusual or unexpected results or deviations.
Ensure that systems are in place to assure trending of data for any anomalies. Provide technical and strategic leadership to Quality Shared Services as Subject Matter Expert in cross-functional, cross-departmental work teams and participate in the site team, which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
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Participate in tokyo dating spottings related teams working towards the goal of continuous improvement. Define departmental roles and accountabilities.
Establish and communicate performance objectives for staff that are consistent with the businesses unit goals, Quality and Technical Operations objectives. Define and enforces performance measures, provide developmental feedback and coaching and create a collaborative environment that attracts, develops and retains the best talent.
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Ensure all Quality Shared Services personnel have adequate training, tokyo dating spottings and experience to perform their GMP related job function effectively. Qualifications: Knowledge of science generally attained through studies resulting in a Master of Science degree in science, engineering, biochemistry, related discipline, or its equivalent is required A minimum of 10 years experience in biopharmaceutical quality with a minimum of 6 years of increasing management responsibility of a biologics Quality Control laboratory or a related biopharmaceutical industry.
In depth knowledge of quality system operations including method trending, investigations, equipment qualification, and the application and interpretation of GMP concepts and compendia requirements e.
Experience in building tokyo dating spottings growing an organization into a high performance team. Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
Extensive and proven experience in FDA or other regulatory authority Preapproval Inspection preparation and management is essential. Demonstrated leadership, interpersonal, communication, and motivation skills.
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Knowledge of manufacturing executions systems such as Syncade, SmartLab; and distributive control systems such as DeltaV is desirable. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.
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