Associate Director, GCP Quality Lead

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.

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. Read more: careers.bms.com/working-with-us

Duties and Responsibilities:

• Design and implement the GCP quality strategy for the assigned molecule

• Assess specific risk areas - brings ideas and strategies to the forefront and propose modifications to the Quality Assurance Program where necessary

• Identify and drive continuous quality process improvements as a consequences of audits, assessments, inspections, trends/metrics and root cause analysis

• Lead implementation of Quality by Design principles for the molecule

• Develop, implements and maintain the molecule quality plan summarizing the quality strategy by summarizing the result of evidence of quality activities

• Integrate end –to end quality principles and review project milestones with R&D

• Establish strong partnership with business stakeholder

• Seek to understand and evaluate their priorities

• Actively participate in and make meaningful contributions

• Deliver independent expert support and propose solutions

• Present key data (compliance, conformance, issues and risks) to drive decision making

• Manage for cause, critical and/or complex quality issues as well as serious breaches for the assigned molecule

• Engage in appropriate activities to support product submissions

• Ensure successful Health Authority engagement

• Demonstrate implementation of quality strategy to Health Authorities

• Create quality plan to be shared with Health Authorities

• Prepare for inspections and support inspections

• Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.

Required Qualifications:

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training and experience

• Minimum 8 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance

• Demonstrated strong knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance

• Understanding of BMS’s therapeutic areas (Oncology, Cardiovascular, Hematology, Cell Therapy and Immunology and Fibrosis)

• Demonstrated applied knowledge of clinical/pharmacovigilance and regulatory requirements, as well as analytical, organizational and planning skills

• Broad 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 regulatory inspection preparation, management, and related follow-up

• Proven problem-solving skills to prevent and overcome complex process and quality-related issues during clinical program implementation and execution

• 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; excellent presentation skills for compelling peer and Senior Management communication

• Project Management: Must be able to manage projects and deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines

• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies

• Microsoft Suite, Veeva Vault QMS, SharePoint, other systems as assigned/applicable

BMSBL

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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