Senior Manager, GXP IT Quality Assurance and eCompliance

Company: E.R. Squibb & Sons
Location: New Brunswick
Posted on: June 22, 2022

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.Education:Master of Science with 3 years' experience or a Bachelor of Science with 5 years' experience or Diploma holders with commensurate experience in regulated industry (e.g. 10+ years)University graduate (science degree preferred)Competency requirements:Excellent team player attitudeExperience in the Biotech/Pharmaceutical Industry or similar, regulated industry requiredExcellent analytical, interpersonal and communication skills, including written and verbal communicationPrevious experience as a computer system validation/quality assurance/quality control analyst for a life sciences company regulated by the FDA preferred.Experience in industry accepted software development and validation life cycle programs and related IT controls.Understanding of quality risk-management concepts (ICH Q9) preferred.Familiarity with drug development process from discovery through regulatory filing and approval of drug applications as well as commercial manufacturing processes.Strong sense of ethics, diplomacy and discretionCommitment to QualityAbility to support various projects, create and work within internal timelines, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional teamAble to work effectively with multicultural workforceAbility to manage competing prioritiesPosition ResponsibilitiesProvide quality assurance oversight across the end-to-end product lifecycle (GPS and R) for software development and validation lifecycle activities associated with regulated computerized systems to ensure conformance to cGxPs, guidance documents, applicable industry accepted standards and BMS requirements.Carries out functions of the GQ GxP-ITQA Quality and eCompliance tower as directed including but not limited to:Review and approval of key computer system validation life cycle (VLC) deliverablesOversight of key software development life cycle (SDLC) processes such as problem, incident, change, release, deviations, etc.QA Review and approval of validation deliverables associated with various BMS systems such as clinical study databases electronic Case Report Forms (eCRF) and Interactive Response Technologies (IRT), enterprise commercial manufacturing systems such as electronic laboratory notebooks and manufacturing execution systems, local laboratory systems such as FTIR or HPLC systems and others as required.Ensure adequate and timely quality assurance/regulatory compliance supportReport on key metrics across the towerProvide support during regulatory agency and third party inspectionsResearch new technologies, understand existing processes and reference recognized standards and frameworksPursue continuous professional development through company paid internal/external training, certifications and/or continuing educationIdentify opportunities for continuous improvementAdherence to BMS Core BehaviorsMeeting ParticipationAttend GQ ITQA Compliance tower meetingsAttend GQ ITQA departmental meetingsInterface meetings with functional areas supportedDepartmental meetingsTravel- 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. 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: E.R. Squibb & Sons, New Brunswick , Senior Manager, GXP IT Quality Assurance and eCompliance, IT / Software / Systems , New Brunswick, New Jersey