Bristol Myers Squibb SENIOR SPECIALIST, QUALITY & INSPECTION READINESS in Princeton, New Jersey
Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.
Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.
Support a strong pharmacovigilance quality system by contributing toward inspection readiness and continuous improvement activities including leading and facilitating investigation of quality issues, identifying root cause analysis, and effective corrective and preventive actions.
Key Responsibilities and Major Duties:
Support the trending and leverage industry intelligence relating to PV inspections and share results with teams in order to improve the effectiveness of the PV Quality System
Support the development of tools and support material to ensure GPVE remains inspection ready including but not limited to checklists, inspection guides, training materials
Support and eventually lead investigations into quality issues within the GPVE group including event analysis, root cause analysis, risk management, corrective action, and effectiveness measures
Support internal audits and external inspections of GPVE and associated safety processes
Support root cause analysis, CAPA identification and implementation
Promote the spirit of proactive, continuous quality improvement
Bachelor's degree with a minimum of two to three years pharmaceutical industry experience, and with a minimum of one year in pharmacovigilance, drug development, clinical development or regulatory affairs.
Prior knowledge of the development and management of procedural documents for pharmacovigilance.
Demonstrated ability to work in a complex, changing environment and be accountable for actions and results.
Demonstrated effective oral/written communication and strong interpersonal relationship skills.
Ability to matrix-manage, including senior leadership.
Knowledge of worldwide regulations pertaining to pharmacovigilance and Bristol-Myers Squibb policies and procedures.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.