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Job Details


Bristol Myers Squibb

Sr Manager QA Labeling and Document Control

Agriculture and Forestry

Agricultural Manager

No

Bothell, Washington, United States

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.

Serve as the subject matter expert for product labeling and batch issuance representing the Bothell site. Support the Label Issuance and batch issuance team in issue resolution and continuous improvement initiatives within the labeling and issuance process. Serve on global and cross functional teams representing the Bothell site.

Education:

Bachelors degree or equivalent.

Experience:

  • Minimum of 7 years working in the biopharmaceutical, cellular therapy, or gene therapy industries.
  • Preferred experience in Labeling and Document Management.
  • Experience managing teams in a fast-pace environment.
  • Experience in the implementation and execution of Quality Systems.
  • Strong technical writing skill set
  • Quality and continuous improvement mindset
  • Collaborate within cross functional departments to help team deliver on time sensitive projects
  • Strong project planning skills
  • Strong computer skills with MS Office (e.g. Word, Adobe, Visio and Excel) and with Quality Systems (e.g.Veeva Document Management System, Quality Management System)
  • Experience interacting with FDA or other regulatory agencies strongly preferred
  • Strong knowledge of cGMPs and domestic regulatory requirements
  • Knowledge of manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, etc.)

Responsibilities:

  • Serves as primary point of contact for site functional areas regarding labeling and label controls; subject matter expert for final product labels, batch record and label issuance.
  • Identifies, sponsors and drives labeling and issuance process improvements.
  • Sets clear performance standards and holds team accountable for results; values, recognizes and rewards the achievement of others; promotes teamwork.
  • Writes and maintains the label and batch issuance procedures and participates in the development and deployment of document control tools.
  • Develops and delivers training regarding process or system changes.
  • Supports internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during the audit. Assist with document retrieval /organization support during regulatory inspections.
  • Performs routine and ad hoc labeling and issuance metric reporting and analysis for the local site data. This may require the use of relational databases and reporting tools to collate and analyze quality data.
  • Monitors label issuance function; investigates and coordinates with IT and MES System Administrators on any issues.
  • Provides communication as to the status of deliverables to customers, management and stakeholders.
  • Acts as Subject Matter Expert (SME) to support cross functional groups on root cause analysis and development of corresponding corrective and preventive actions.
  • Issues production batch records to support manufacturing operations.
  • Responsible for managing the Document Control team, including recruitment and performance management.

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.

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.