Senior Director, Data & Vendor Quality
Bristol Myers Squibb
Boudry, CH
vor 1 Tg.
source : DirectEmployers Association

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. Purpose / Objective of the job The Senior Director, Data and Vendor Quality is a critical management position within the R&D Quality organization that is responsible for the development and strategic oversight of the vendor and data quality activities.

The position provides leadership for the identification and resolution of critical quality issues that may affect BMS. The Senior Director, Data and Vendor Quality is also responsible for oversight of interface with global clinical compliance and stakeholder alignment between R&D Q and GDD stakeholders as well as procurement.

The Senior Director Data & Vendor Quality will act as Quality Culture ambassador within R&ED and GDD, with responsibility for influencing senior leadership across BMS with respect to the importance of building continuous quality improvements into the organization.

Research and Development Quality (R&D Qua lity) is responsible for the following : + 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 develop Quality Management Systems training elements Key Responsibilities and Major Duties + Provide GCP compliance consultation to stakeholders on quality issue management and process enhancement / compliance - ensuring consistent quality standards and fostering strong working relationships + Promote high standards of quality, compliance, and process excellence through oversight of procedure development / enhancement as well as by leading or contributing to supportive initiatives to ensure delivery of business goals.

  • Develop and implement quality strategy to oversee vendor and data quality + Oversee vendor quality oversight activities and manage external quality (e.
  • g. quality agreements with CROs) + Oversee the incorporation of new technology and innovation (biostatistics, digital biomarkers, data management, eConsent, eMedical Records ) in clinical trials ensuring data integrity + Oversee the development and implementation of the digitalization strategy for R&D Quality including automation, virtual reality and chat bots.

  • Incorporate global regulatory trends and changes into Vendor and Data Quality + Engage with executive management and cross-functional business partners to identify areas of greatest compliance risk and obtain information and feedback relevant to process improvement;
  • drive issue resolution + Continually evaluate the strategic approach, drive changes in RDQ processes, and modify the RDQ program to meet the changing needs of the organization, regulatory environment and industry best practice + Ensure rapid communication of quality issues, including potential misconduct or issues of significant deviations with project / products, to business partners and senior management Talent Development / Management + Build and maintain a Vendor and Data Quality organization by creating an environment that attracts, develops and retain high-quality employees + Develop hiring plans to staff critical areas in R&D Quality and establish the necessary infrastructure to ensure alignment with corporate objectives + Provide leadership, coaching, professional development, mentoring, and support for direct and indirect reports, including talent planning and performance management + Develop, motivate, and empower direct reports to have a high degree of accountability for performance and the oversight of key deliverables + Engage and energize employees through communication of goals, priorities, and other business critical information as well as recognizing and celebrating success and achievements + Attract high-caliber talent and facilitate functional talent development through coaching and provision of challenging assignments to promote individual and team development + Lead performance management processes to ensure that individuals are held to appropriate, consistent standards and that key leadership development and succession plans are established + Promote a high-performance, externally-focused operating culture throughout organization which emphasizes customer, teamwork, personal accountability, and commitment to quality + Model desired behaviors personally and reinforce desired behaviors at all levels in organization Other + Manage a fiscally responsible department budget including operating expenses, staffing level and outside collaborations + Lead multidisciplinary or cross-functional work / project teams;
  • serve as part of strategic team(s) within the group / discipline + Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross-functional level + May influence the external environment through interactions with regulators, trade associations, or professional societies + Proactively identify risk areas - brings ideas and strategies to the forefront and have a firm grasp of the business needs.

  • Provide input in the global audit plans based on identified signals / trends / risks / gaps + Lead and / or contribute to the implementation of large-scale initiatives and / or organizational changes (such as functional optimization) that affect the department + Liaise with clients in R&D and Business Units to understand global and local needs, and determine priorities Key Stakeholders / Contacts + Part of R&D Quality LT + R&ED and GDD management + Interaction with senior leadership in Global Clinical Operations, Global Pharmacovigilance and Epidemiology, Regulatory and Global Development and Medical to influence decisions impacting quality and compliance related to audits and inspections + Collaborate with senior leadership in other GXP audit functions and corporate compliance to determine audit strategy + 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 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 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 : R1527016 EN Updated : 2020-07-14 00 : 00 : 00.000 UTC Location : Boudry,Switzerland 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.

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