Manager - Data Integrity
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.
- BS or higher degree in a life sciences, engineering, IT, scientific discipline, or other related field.
- Minimum of four (4) or more years of relevant work experience in pharmaceutical industry.
- Thorough and in-depth knowledge of GxP computer system validation (CSV) requirements, 21 CFR Part 11, EU Annex 11 and GAMP standards for DI and validation of automated systems is required.
- Experience in GxP computerized systems in an IT or Manufacturing environment is preferred.
Key Knowledge, Skills, and Abilities
- Demonstrated excellence in written and verbal communication. Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships.
- Demonstrated ability to work effectively with US FDA, EU and other regulatory agencies. Substantial knowledge of QSR, GMP, FDA, GAMP, ICH, ISO and other applicable standards.
- Demonstrated expertise in Data Integrity principles and GxP knowledge with ability to recognize Data Integrity risks and develop mitigation plans.
- Demonstrated experience utilizing Risk Management tools (e.g. FMEA, FTA tools) to understand and reduce overall risks through effective CAPA planning and implementation.
- Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a leader of team(s) to engage and influence team members in a matrixed environment.
Roles and Responsibilities
- Responsible for ensuring systems at the Bothell cell therapy manufacturing site comply with data life cycle requirements from initial data creation/recording to archival and decommissioning. This includes, but is not limited to, data management (e.g., data creation, data processing, review, reporting), data security, data traceability process mapping, data backup/restore, electronic signature/electronic record linking and data audit trails.
- Ensure the validation, implementation and change management of cell therapy manufacturing and laboratory e-systems used across the site operations are conducted in compliance with applicable Data Integrity related regulatory requirements (FDA, EMA, etc.)
- Coordinating all relevant activities with regards to data, information and process flow between Quality, IT and other departments in relation to implementation, maintenance and change management of computerized systems programs.
- Responsible for leading, reviewing, and approving data integrity assessments for GxP systems and processes including, but not limited to, manufacturing and laboratory systems/processes to ensure compliance with regulatory requirements and company established requirements for data integrity.
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 email@example.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.