Executive Director, Clinical Quality Assurance, R&d
vor 3 Monaten
**Working with Us**
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
The Executive Director, Clinical Quality Assurance is a key leader on the R&D Quality Leadership Team responsible for leading the Clinical Quality Assurance function and ensuring the highest standards of quality and compliance in clinical research and related activities. The role is responsible for developing and implementing quality assurance strategies, including therapeutic area, process, and vendor audit and inspection strategies to ensure compliance with regulatory requirements and company standards.
**Key Responsibilities**
- Lead the Clinical Quality Assurance function, providing strategic direction and oversight.
- Develop, implement, and maintain quality assurance policies, procedures, and systems to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
- Translate risk factors into clinical quality assurance oversight plans, including internal and external audit strategies and inspection readiness/management strategies.
- Oversee the planning, conduct, and reporting of internal and external audits of clinical trial investigator sites, vendors, and proceses/systems, including for-cause and directed activities.
- Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to Health Authorities, business partners and senior management
- Lead vendor quality oversight activities and manage external quality (e.g. quality agreements with CROs, set vendor quality councils, etc.)
- Develop quality strategies for new clinical trial technology and approaches (e.g., decentralized trials, real world evidence, digital health, etc.)
- Oversee the development and maintenance of an effective inspection management framework supporting clinical trials.
- Provide leadership and oversight for GCP Inspections ensuring effective readiness, preparation, management, and response development and action closure.
- Ensure timely identification, investigation, and resolution of quality issues and non-compliances.
- Partner with RBQM in the development of the Quality Narrative, specifically developing and contribution the audit/inspection portion.
- Collaborate with Drug Development and other departments to support clinical programs and ensure quality and compliance.
- 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
- Provide leadership, guidance, development and coaching to the CQA team, fostering a culture of quality and continuous improvement.
- Ensure CQA team are trained and qualified to perform audit and inspection related activities.
- Attract, develop, and retain high quality talent within the organization.
- Monitor and interpret regulatory trends and changes, and ensure the company's clinical quality systems are updated accordingly.
- Represent the company in interactions with regulatory agencies.
- Develop and deliver training programs to enhance quality awareness and compliance across the organization.
- Prepare and present quality metrics and reports to senior management and other stakeholders.
- Lead and chair clinical quality council, partnering with RBQM to ensure relevant clinical trial risks are effectively managed and overseen.
- Manage a fiscally responsible department budget including operating expenses, staffing level and outside collaborations
- Engage and influence in external industry consortiums and benchmark opportunities.
**Qualifications & Experience**
- Minimum of BA/BS degree or in a life science discipline; advanced education preferred
- Minimum 20 years Quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles.
- Extensive knowledge of GCP, ICH guidelines, and global regulatory requirements for appropriate strategy setting, decision making, and quality oversight to ensure BMS complies with regulatory requirements..
- Proven experience in leading and managing quality assurance teams.
- Strong analytical, problem-solving, and decision-making 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.
- Experienc
-
Boudry, Schweiz Bristol-Myers Squibb VollzeitWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Clinical Quality
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitBei 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...
-
Vice President, R&d Quality
vor 2 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Associate Director Therapeutic Area Quality
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitBei 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...
-
Clinical Quality
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Associate Director Therapeutic Area Quality
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Senior Quality Assurance Director Cell Therapy
vor 4 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleBristol Myers Squibb is seeking a highly skilled and experienced Quality Assurance professional to join our Cell Therapy team as a Senior Quality Assurance Director Cell Therapy. This is an exciting opportunity to work on a global scale and be part of a team that is transforming the lives of patients through science.Key ResponsibilitiesProvide...
-
Regional Lead for Clinical Operations
vor 3 Wochen
Boudry District, Schweiz Bristol Myers Squibb VollzeitAbout the RoleThe Director, Regional Delivery Lead is a leadership position within the Regional Clinical Operations function at Bristol Myers Squibb. This role is crucial to the success of the company's R&D pipeline and reports to the Executive Director, Head of Regional Delivery Lead.Key ResponsibilitiesThis role involves driving strategy and operational...
-
Director, Regional Delivery Lead
vor 6 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Director, Regional Delivery Lead
vor 6 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Executive Director, Worldwide Medical Oncology
vor 5 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Director, Quality Operations
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Director, Worldwide Medical Oncology, Medical
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Director, Cell Therapy, Medical Communications
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Director, Worldwide Medical Hematology, Medical
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Director, Worldwide Medical Cardiovascular
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Senior Clinical Data Management Lead
vor 3 Wochen
Boudry, Schweiz Bristol-Myers Squibb VollzeitWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the...
-
Senior Manager, Clinical Data Management
vor 6 Monaten
Boudry, Schweiz Bristol Myers Squibb VollzeitDescription : Clinical Data Management key focus is to ensure data quality, integrity & completeness of all data types (eCRF and non eCRF) collected in BMS clinical trials from study start to database Lock. Position Summary: The Senior Manager, Clinical Data Management is a leadership role considered essential to the sustainability and success of...
-
Director, Worldwide Medical Immunology and
vor 7 Monaten
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...
-
Boudry District, Schweiz Bristol Myers Squibb VollzeitTransforming Lives through ScienceBristol Myers Squibb is a leading biopharmaceutical company dedicated to discovering and developing innovative treatments that transform patients' lives. We're seeking an exceptional Clinical Operations Director Lead for Global Trials to join our team.About the RoleThis leadership position plays a critical role in driving...
