Senior Manager, Quality Assurance Specialist

Role Overview: Working at Bristol Myers Squibb offers you challenging, meaningful, and life-changing experiences every day. You will have the opportunity to be part of uniquely interesting work that transforms the lives of patients and your career. The company provides a work environment that values balance and flexibility, offering competitive benefits, services, and programs to support your personal and professional goals. Key Responsibilities: - Identify opportunities for process improvements related to CAPA management by analyzing current workflows, systems, and procedures. - Lead cross-functional teams in driving process improvement projects from start to finish. - Manage the CAPA process, including identifying, investigating, and resolving non-conformances. - Act as a CAPA lead investigator, conducting root cause analysis and impact assessments of deviations, audits, inspections, and quality events. - Serve as a subject matter expert to develop robust CAPAs resulting from deviations and audits. - Present investigation findings to key stakeholders and track CAPAs to completion. - Provide training and support on process improvement methodologies and CAPA management. - Monitor the effectiveness of implemented CAPAs through data analysis and performance metrics. - Utilize Quality Risk Management and Operational Excellence principles to drive continuous improvement. - Stay updated on industry best practices and regulatory requirements. - Develop CAPA metrics and trend analysis to identify areas for improvement. - Prepare reports on process improvement activities and CAPA status for senior management. - Serve as the Infinity system superuser and provide training to users as needed. - Maintain strong working relationships with key stakeholders across the organization. - Practice teamwork, inclusion, commitment to quality, global awareness, adaptability, issue analysis, and innovation. Qualifications & Experience: - Bachelor's or Master's degree in Chemistry, Biology, Health, Quality, or related field. - Minimum 7+ years of experience in GxP CAPA Management in Quality, Clinical Development, or Regulatory Compliance. - Proficiency in Advanced Finding Investigation and Root Cause Analysis (RCA). Required Competencies: Knowledge, Skills, and Abilities: - In-depth knowledge of GCP guidelines, Quality Assurance principles, and Clinical Trial Execution. - Strong problem-solving skills and quality mindset. - Excellent interpersonal, oral, and written communication skills. - Ability to work in a complex environment and deliver results under pressure. - Demonstrated critical thinking and ethical decision-making abilities. - Experience in using data analytics tools. - Promotes continuous improvement and maintains confidentiality. - Fluent in English with professional proficiency in reading, writing, and speaking. If you find a role that interests you, even if it doesn't align perfectly with your background, consider applying. Bristol Myers Squibb offers uniquely interesting work and life-changing career opportunities for individuals willing to grow and thrive in a supportive and inclusive culture.,