Bei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu Innovationen bei, die bedeutende Veränderungen vorantreiben. Wir verleihen jeder Therapie, für die wir Pionierarbeit leisten, eine menschliche Note. Kommen Sie zu Bristol Myers Squibb und machen Sie einen Unterschied.
Position Summary
The Director, Therapeutic Area (TA) Quality Lead will be mainly responsible for managing the Therapeutic Area activities from a quality perspective and delivering the full range of quality related activities in support of the TA. The incumbent is a single point of contact for R&D Quality for the Therapeutic Area.
Key Responsibilities
- Design and implement end-to-end quality strategy for respective Therapeutic Area Ensure successful Health Authority (HA) engagement.
- Manage for cause, critical and/or complex quality issues as well as serious breaches for the TA;
- Engage in appropriate activities to support product submissions.
- Establish strong partnership with business stakeholders.
- Interaction with leadership in R&ED and GDD, Patient Safety and Regulatory to influence decisions impacting quality and compliance related to the TA
- Interactions with peers in R&D Quality and Global Quality
- Interactions with external auditors from partner companies and health authority inspectors during the conduct of health authority inspections
- Contact with appropriate technical, supervisory and management personnel internally and externally (BMS sites, vendors, partners etc.) in the conduct and reporting of potential serious breaches, inspections, and audits
- External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers
- Internal engagement as needed with relevant R&D partners and corporate functions
Other
- Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline
- Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department
- Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines
- Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation.
- Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level
- Provide input in the global audit plans based on identified signals/trends/risks/gaps
- May influence the external environment through interactions with regulators, trade associations, or professional societies
- Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems
Research and Development Quality is responsible for the following:
- Defines and oversees 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 develop Quality Management Systems training elements
Qualifications & Experience
Education and Experience:
- B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
- Minimum 10 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
Required Competencies: Knowledge, Skills, and Abilities
- Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
- Very experienced in nonclinical/clinical research/pharmacovigilance experience
- In-depth 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
- Understanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)
- Extensive experience in regulatory inspection preparation, management, and related follow-up
- Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data
- Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution
- Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication
- Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines
- Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies
- Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies
- Fosters a culture in which people continually work to improve services, and work processes
Wir setzen uns auf der ganzen Welt leidenschaftlich dafür ein, das Leben von Patienten mit schweren Krankheiten zu beeinflussen. Unsere gemeinsamen Werte Leidenschaft, Innovation, Dringlichkeit, Verantwortlichkeit, Inklusion und Integrität befähigen uns, unsere individuellen Talente und unterschiedlichen Perspektiven in einer integrativen Kultur einzusetzen und bringen das höchste Potenzial jedes unserer Kollegen hervor.
Bristol Myers Squibb weiß um die Bedeutung von Balance und Flexibilität im Arbeitsumfeld. Wir bieten daher eine Vielzahl von attraktiven Benefits, Dienstleistungen und Programmen an, die unseren Mitarbeitern die Ressourcen bieten, ihre Ziele sowohl bei der Arbeit als auch in ihrem Privatleben zu verfolgen.
