Apply for Bristol Myers Squibb Hiring for Senior Manager / QA Specialist Hyderabad. 7+ years GxP CAPA management experience required.
Company: Bristol Myers Squibb (BMS)
Job Title: Senior Manager, Quality Assurance Specialist
Location: Hyderabad, Telangana, India
Employment Type: Full-Time
Experience Required: Minimum 7 years
Education Qualification: B.S. or M.S. in Chemistry, Biology, Health, or Quality-related field
Job Requisition ID: R1595968
Application Mode: Online
About Bristol Myers Squibb
Bristol Myers Squibb (BMS) is one of the world’s leading biopharmaceutical companies dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. The organization is globally recognized for its transformative research and innovation in therapeutic areas such as oncology, hematology, immunology, and cardiovascular health. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
At BMS, work is challenging, meaningful, and life-changing. Every employee contributes to research and solutions that impact millions of lives worldwide. The company fosters an inclusive work environment that values balance, growth, and collaboration. Employees are encouraged to explore unique opportunities for professional and personal development, with access to world-class resources, competitive benefits, and leadership support. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
About the Role: Senior Manager, Quality Assurance Specialist
Bristol Myers Squibb is inviting applications for the position of Senior Manager, Quality Assurance Specialist, based in Hyderabad. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
This role is designed for experienced professionals passionate about Quality Assurance (QA) and Corrective and Preventive Action (CAPA) Management within the pharmaceutical or clinical research sector. The Senior Manager will lead CAPA investigations, ensure regulatory compliance, and implement continuous improvement processes across BMS’s clinical and quality systems.
The selected candidate will play a pivotal role in maintaining BMS’s global quality standards and ensuring excellence in GxP (Good Practice) operations.
Key Responsibilities
The Senior Manager, Quality Assurance Specialist will be responsible for overseeing CAPA processes, leading investigations, ensuring compliance, and driving quality improvements. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
1. CAPA Management and Investigation
- Manage the end-to-end CAPA process, including identification, investigation, documentation, and resolution of non-conformances.
- Act as a CAPA lead investigator for GCP deviations, audits, inspections, and quality events.
- Conduct detailed root cause analyses (RCA) and ensure effective corrective and preventive actions.
- Track CAPA implementation, monitor effectiveness, and present findings to key stakeholders across Global Drug Development (GDD) and Global Quality (GQ) teams.
2. Process Improvement
- Identify opportunities for process optimization within CAPA management, audit readiness, and compliance systems.
- Lead cross-functional teams in the design and execution of process improvement projects.
- Apply Quality Risk Management (QRM) and Operational Excellence (OpEx) principles to ensure data-driven decision-making.
- Develop CAPA metrics and perform trend analyses to identify recurring issues and drive improvements.
3. Regulatory Compliance and Quality Oversight
- Maintain an expert-level understanding of GxP, ICH-GCP, and FDA guidelines.
- Ensure compliance across all clinical and quality operations.
- Support internal and external audits by providing CAPA documentation and quality reports.
- Ensure that CAPA actions align with company policies, regulatory requirements, and industry standards.
4. Data Analytics and Performance Monitoring
- Use data analytics tools such as control charts, histograms, heat maps, and box plots to evaluate CAPA effectiveness.
- Prepare periodic reports on CAPA trends, deviations, and process improvements for senior management review.
- Support data-driven decision-making through continuous monitoring and reporting.
5. Leadership and Training
- Provide training and mentoring to staff on CAPA processes and quality management principles.
- Serve as a subject matter expert (SME) for CAPA investigations and documentation best practices.
- Function as the Infinity system superuser, assisting in system operations and user training.
- Promote teamwork, collaboration, and inclusion across departments.
6. Stakeholder Collaboration
- Foster strong partnerships with internal and external stakeholders.
- Collaborate with global teams to ensure consistent application of CAPA procedures and continuous improvement initiatives.
- Present investigation findings and status reports to leadership teams and regulatory bodies when required.
Qualifications and Experience
To excel in this role, candidates should possess a blend of academic qualifications, hands-on experience, and strong analytical and leadership skills. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
Educational Requirements:
- Bachelor’s or Master’s degree (B.S. / M.S.) in Chemistry, Biology, Health Sciences, or Quality Management, or an equivalent combination of education and experience.
Professional Experience:
- Minimum 7+ years of experience in GxP CAPA Management within Quality Assurance, Clinical Development, or Regulatory Compliance.
- Proven experience in root cause analysis, CAPA execution, and process improvement.
- Prior experience in Clinical Trial Execution (e.g., CRA, Clinical Trial Manager) preferred.
Technical Expertise:
- Advanced proficiency in Root Cause Analysis (RCA) methodologies.
- Familiarity with GCP guidelines, ICH standards, and FDA regulations.
- Experience with data analytics, including statistical tools for performance evaluation.
- Ability to interpret and apply regulatory requirements in real-world clinical and manufacturing environments.
- Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
Required Skills and Competencies
1. Quality and Compliance Expertise
- Strong knowledge of Quality Management Systems (QMS) and CAPA documentation.
- Demonstrated ability to implement effective preventive actions and quality improvements.
- Strong problem-solving mindset with attention to detail.
2. Communication and Collaboration
- Excellent written and verbal communication skills in English.
- Ability to collaborate across departments and global teams.
- Capable of presenting investigation findings and reports to senior management with clarity and professionalism.
3. Leadership and Initiative
- Proven leadership in managing complex quality investigations.
- Ability to influence and lead cross-functional teams toward continuous improvement goals.
- Self-motivated, with a sense of urgency and accountability.
4. Data-Driven Decision Making
- Competence in using analytics and visualization tools to interpret CAPA data.
- Skilled in identifying trends and making data-backed recommendations.
5. Global Awareness and Adaptability
- Understands international quality and compliance implications.
- Adapts strategies for diverse regulatory environments across global sites.
- Flexible and resilient in handling shifting priorities and tight timelines.
Work Environment and Collaboration Model
Bristol Myers Squibb offers a hybrid and collaborative work environment designed to support innovation and work-life balance. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
- Site-Essential Roles: Require full-time on-site presence.
- Site-by-Design Roles: Offer hybrid flexibility with at least 50% on-site work.
- Field-Based/Remote Roles: Require travel to sites and partner meetings as needed.
For this role, the Senior Manager, Quality Assurance Specialist position is site-by-design, ensuring a balance between in-person collaboration and flexibility for remote work when required. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
Company Culture and Values
At BMS, every employee is driven by the mission to transform patients’ lives through science. The company’s culture is built around six core values: Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
- Passion – for innovation and patient care.
- Innovation – advancing cutting-edge therapies.
- Urgency – delivering impactful results quickly and effectively.
- Accountability – maintaining integrity and responsibility in every action.
- Inclusion – embracing diverse perspectives and backgrounds.
- Integrity – adhering to the highest ethical standards in all operations.
BMS also emphasizes inclusivity, work-life balance, and professional growth. Employees have access to comprehensive benefits, including health coverage, career development programs, flexible work options, and wellness initiatives. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
Application Details
Interested candidates can apply directly through the official Bristol Myers Squibb careers portal:
Job Requisition ID: R1595968
Location: Hyderabad, Telangana, India
Candidates who meet most of the qualifications but may not fulfill every single criterion are encouraged to apply — BMS values diverse experiences and growth potential. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
Why Join Bristol Myers Squibb
Joining BMS as a Senior Manager, Quality Assurance Specialist offers a unique opportunity to be part of a global organization known for scientific excellence, ethical leadership, and innovation. You will contribute to ensuring product quality, patient safety, and global regulatory compliance while working in a collaborative and empowering environment. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
This position is ideal for professionals who thrive in analytical roles, enjoy process optimization, and are driven by a passion for quality and patient care. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
Conclusion
The Senior Manager, Quality Assurance Specialist position at Bristol Myers Squibb Hyderabad is an excellent opportunity for seasoned QA professionals to take their careers to the next level. This role combines leadership, technical expertise, and process innovation within one of the world’s most respected pharmaceutical organizations. Bristol Myers Squibb Hiring for Senior Manager / QA Specialist
If you have the experience, leadership skills, and dedication to quality excellence — now is the time to join Bristol Myers Squibb and make a global impact.
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