Field Quality, QA Operations Manager

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. 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. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Field Quality, QA Operations Manager

Provide Quality assistance and oversight to operations, for in-process intermediates and manufactured products, and other GMP processes as required. Performs review and approval of documentation associated with in-process materials, and manufactured product. Assists in the identification, generation and quality review of investigation records that may result during day-to-day operations. Assure the quality of manufactured products complies with all applicable regulations and guidelines.

Responsibilities:

• Provide Quality support for complex documentation revisions

• Provides oversight of the review and approval of changes to master batch records or Syncade recipes.

• Lead or participate in quality forums and governance for batch record review, MBR improvement, change controls and EAC.

• Develop, maintain, and act upon Quality key performance indicators.

• Quality support for area related change controls.

• Assist supervisor with developmental feedback and coaching of Field Team members and contribute to creating a collaborative environment enhances unit performance and integration across site departments.

• Reviews, approves and provides guidance for quality master data and NMR requests.

• Directly participates in internal audits or reviews as well as global health authority inspections. May include representation on inspection response and CAPA teams.

• Provide Quality review and approval of investigation records and CAPA, records including potential impact/RCA investigations

• Provides for strategic foresight to identify and implement changes to enhance long term goals of the department and drive continuous improvement.

• May act as delegate for QA Operations Senior Manager for departmental meetings, projects, and tasks.

• May perform Routine Field QA activities as overflow, MBR review, Floor Support Activities, including alarm review, logbook review, etc.(As needed)

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

Qualifications:

• A preferred of 6-8+ years experience in biopharmaceutical industry, with 2 years in a quality function preferred.

• Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.

• Knowledge of US and EU cGMP regulations and guidance.

• Knowledge of electronic systems including any of the following: SAP, LIMS, QMS, and electronic batch recording systems, is desirable. Microsoft Office suite knowledge and proficiency with Excel is desirable.

• Strong background and demonstrated effectiveness in quality assurance operation and compliance of commercial biologics manufacturing with direct accountability for final product release.

• Knowledge in Operational Excellence and Continuous Improvement is desirable.

• Demonstrated matrix leadership, interpersonal, communication, and motivation skills.

• Excellent writing and oral communication skills are required.

• Well practiced in exercising sound judgment in decision-making.

• Experience where one was required to work in a team-based environment with a diverse group of people.

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Around the world, we are passionate about making an impact on the lives of patients with serious diseases. 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. 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.

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

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