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Manager Computer System Validation

Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: October 17, 2020

Job Description:

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. Key Responsibilities and Major Duties General Activities 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 the GQ GxP-ITQA CSV tower 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 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 Degree/Certification/Licensure University graduate (science degree preferred) University Graduate; Life-Sciences degree preferred. Experience --- Responsibility and minimum number of years Minimum of 5-7 years--- experience providing quality oversight for the development, testing, implementation and validation of computerized systems used by pharmaceutical companies Proven experience in the interpretation and understanding of GxPs for the controlled management of electronic records and signatures (minimum 5-7 years--- experience). Key Competencies --- knowledge, skills, abilities, other Experience with Trackwise or similar quality management systems preferred Experience with HP ALM preferred Experience in the Biotech/Pharmaceutical Industry or similar, regulated industry required Excellent analytical, interpersonal and communication skills, including written and verbal communication Previous experience as a quality manager or CSV engineer for a life sciences company regulated by the FDA preferred 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 Good understanding of the drug and device development process from discovery through to regulatory filing and approval of drug applications as well as commercial manufacturing processes. 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. Ability to manage competing priorities Working Conditions Travel Required (nature and frequency) About 5-10 % travel to meet with stakeholders, attend professional meetings and seminars 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.

Keywords: Bristol Myers Squibb, New Brunswick , Manager Computer System Validation, Executive , New Brunswick, New Jersey

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