Senior Manager, GxP IT Quality Assurance & E-Compliance

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Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us . The position is in the Corporate Quality / IT Quality & Data Integrity department and is responsible for providing oversight for the management of Computer System Validation, electronic records and/or electronic signatures in compliance with world-wide health authority regulations. Key reponsibilities: Provide computer system validation and software development oversight to assure regulatory compliance across the end-to-end product lifecycle (GPS and R&D) to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements. Carries out functions of IT-QA as directed including but not limited to: Review and approval of key computer system validation life cycle (VLC) deliverables. Oversight of key software development life cycle (SDLC) process such as problem, incident, change, release, etc. Ensure adequate and timely regulatory compliance support. Report on key metrics across the tower. Provide active support during internal audits, regulatory agency and third-party inspections. Research new technologies, understand existing processes, and reference recognized standards and frameworks. Operate effectively and with minimal supervision, within a team or independently, performing special projects and related duties, as assigned. Pursue continuous professional development through company paid internal/external training, certifications and/or continuing education. Identify opportunities for continuous improvement. Adherence to BMS core behaviors Specific knowledge, skills, abilities: Strong Knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (E.g., GxP, 21 CFR Part 11) In-depth understanding of industry accepted software development and validation life cycle programs and related IT controls Previous experience in risk-based approach to computerized system validation a plus. Understanding of quality risk-management concepts (ICH Q9) preferred Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required. Experience with quality management systems preferred. Experience with HP ALM preferred. Excellent analytical, interpersonal and communication skills, including written and verbal communication. Strong sense of ethics, diplomacy and discretion. Commitment to Quality. Strong critical thinking to analyze complex situations and discern critical issues. Ability to manage various projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team. Able to work effectively with multicultural workforce. Excellent team player attitude. Education/Experience/ Licenses/Certifications: Bachelor's degree in Computer Science, Information Technology, Life Science or a related field, Advanced degree preferred. Minimum of 5-7 years' experience providing quality oversight for the development, testing, implementation, and validation of computerized systems used by pharmaceutical companies. Travel: About 5-10 % travel to meet with stakeholders, attend professional meetings and seminars #BMSBL #LI-Hybrid If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Compensation Overview: New Brunswick - NJ - US: $142,040 - $172,113 The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/. Benefit offerings are s

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