Bristol Myers Squibb Senior Manager, Regulatory Affairs Quality, PV & LCM Quality in Boudry, Switzerland
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 PV and Lifecycle Management Quality pillar in RDQ provides independent quality oversight on the clinical safety/PV, RA, and MA quality management systems applied during the lifecycle of products, managed by global internal and external stakeholders. In addition to providing PV, RA, MA quality SME consultancy, the primary focus of the group are to:
Continuously monitor the health of the QMS and initiate actions where needed;
Watch Health Authority commitments, submission strategies and the planning/execution thereof;
Manage/support PV inspections;
Execute risk-based PV audits.
Key responsibilities of the Senior Manager, Regulatory Affairs Quality, PV & LCM Quality include:
Contribute to the quality management system relating to Regulatory Affairs activities, throughout the product lifecycle.
Assist with the management of critical and/or complex quality issues in the PV & LCM Quality remit
Advise on regulatory affairs related matters across the product lifecycle
Support Health Authority inspection management activities and internal GxP audit activities, as assigned
Establish strong partnerships with business stakeholders.
Define and oversee the global quality strategy for early R&D Development up to phase IV Projects and ensure that GxP Quality Management Systems are implemented and in use
Translate QMS elements into the R&D processes and ensure feedback to the central QMS team
Lead the Quality and Compliance R&D Escalation Process
Ensure GLP systems are in place, studies are audited and lead analytical path of Translational Medicine
Oversee the Data generation and data integrity from laboratory work and non-clinical phase projects
Ensure Quality is Designed into non-clinical trials and clinical protocols using data and information from discovery phase, non-clinical and clinical studies
Oversee process development, manufacturing and release of clinical supplies to clinical trials protocols
Advice on Franchises (including Cell Therapy) and Clinical Operations development projects
Lead Qualification of vendors and manage external Quality Systems
Execute GCP and Pharmacovigilance audits and support GCP and Pharmacovigilance Regulatory inspections
Ensure that GxP follow-up CAPA activities are completed
Oversee study centers, countries, investigators and connect with PV, Medical Affairs and Regulatory Affairs
Contribute to developing Quality Management Systems training elements
University Graduate, Life Sciences or Quality related degree preferred or equivalent combination of education, training, and experience.
Demonstrated expertise and specific technical knowledge of, regulatory affairs activities of at least 4 years, from CRO or pharmaceutical company.
Demonstrated knowledge of global regulatory processes and principles of Quality Assurance
Understanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology, and Fibrosis)
Knowledge of pre-and post-marketing regulatory requirements, as well as analytical, organizational, and planning skills
Knowledge of applied risk management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment, and the review of continuous risk management
Experience in supporting regulatory inspection preparation, management, and follow-up activities
Proven problem-solving skills to prevent and overcome complex process and quality-related
Proficiency in utilizing data to generate insight and to formulate clear business questions that can be answered with data
Communication Skills: Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external customers; good presentation skills
Project Management: focuses on the delivery of timely and high-quality outputs. Proactively communicates changes in pre-established goals.
Software that must be used independently and without assistance (e.g., Microsoft Suite)
Microsoft Suite, Veeva Vault QMS, SharePoint, other systems as assigned/applicable
Travel Required (nature and frequency): Up to 25% travel to prepare inspections, support audits, and to 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.
Company: Bristol Myers Squibb
Req Number: R1546066
Updated: 2021-09-22 03:12:29.977 UTC
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.