Sr. Specialist, Quality E-Systems
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.
The Senior Specialist, Quality E-Systems primary responsibility is to help assure the quality, integrity, and compliance of site Information Technology (IT) systems, and maintain alignment between business process owners, end users, and other cross functional areas. Altogether, the Senior Specialist will help ensure that IT systems are designed, setup, and function in a GMP-compliant manner which, in turn, will assist the site in safeguarding and maintaining the safety and quality of Bristol Myers Squibb (BMS) products.
The Senior Specialist, Quality E-Systems is also responsible for assisting with implementation of the Phoenix Data Integrity program.
The Senior Specialist, Quality E-Systems reports to the Senior Manager, QS Compliance.
Required Competencies: Knowledge, Skills, and Abilities
- Intermediate knowledge of GMP guidance and regulations, including those pertaining to computerized system design, function, and use.
- Intermediate knowledge of data integrity principles (ALCOA+) and industry guidelines for data integrity.
- Familiarity with Computer System Validation and knowledge with 21 CFR Part 11 requirements.
- Ability to recognize data integrity risks and assist with remediation efforts.
- Intermediate knowledge of Microsoft Word, Outlook, and Excel.
- Requires ability to communicate appropriately with regulatory agencies.
- Intermediate written and verbal communication skills.
- Intermediate problem-solving, critical-reasoning, and decision-making skills.
- Intermediate time-management, organizational, and multi-tasking abilities.
Maintains the quality, integrity, and compliance of company IT systems in order to help assure the safety and quality of BMS products. Participate in data integrity related activities.
- Provides input and quality approvals for validation documentation that supports applicable site owned systems.
- Provides input and quality approvals for site Enterprise Resource Planning (ERP) master data.
- Completes quality activities for audit trails and user access related to periodic review.
- Ensures data integrity principles and concepts are incorporated in the lifecycle of IT systems.
- Applies data integrity regulations and guidance from governing agencies when participating in site and global projects related to computerized systems.
- Drives use of best practices during IT systems design, validation, and use.
- Collaborates with business stakeholders, technical support groups and Quality Assurance (as needed) to thoroughly investigate validation or computer system discrepancies.
- Ensures all required system documentation is maintained as changes in the system(s) are made. Documentation includes but not limited to functional requirements, user requirements, and design specifications.
- Reviews and approves documents, change controls, and protocols related to IT systems.
- Supports the integration and deployment of local and Enterprise systems.
- Supports deviations, CAPAs, and Change Controls as needed.
- Represents Phoenix Quality during the initiation and implementation of projects related to electronic systems.
- Supports continual alignment of the business process with other business functions and provides effective on-going end user support.
- Develops, maintains, and improves key business processes.
- Participates and supports site data integrity initiatives.
- Assists/facilitates Data Integrity Risk Assessments for systems and processes.
- Drafts, reviews, and edits SOPs, process flow, and other business documentation.
- Performs all other tasks as assigned.
Requires travel < 5% of time.
This is a hybrid 50/50 onsite/remote role
Qualifications & Experience
- Bachelor’s degree preferred, preferably in Science or Engineering.
- 5 years’ relevant work experience required, preferably in a regulated pharmaceutical environment.
- An equivalent combination of education, experience and training may substitute.
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
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.