Senior Manager, Quality Assurance Specialist

Bristol Myers Squibb; Hyderabad; On-site; INR 1,500,000 - 2,500,000; Full time

Benefits offered by this job

Wide variety of competitive benefits

Flexible work environment

Job summary

A leading global biopharmaceutical company seeks a Senior Manager, Quality Assurance Specialist in Hyderabad. This role involves managing CAPA processes and leading cross-functional teams to drive quality improvements. Candidates should have over 7 years of GxP CAPA management experience and strong skills in process analysis and communication. The position offers opportunities for professional growth in a dynamic environment.

Qualifications

• Minimum 7+ years GxP CAPA Management experience.
• Advanced Finding Investigation and Root Cause Analysis proficiency.
• Experience with data analytics.

Responsibilities

• Identify opportunities for process improvements.
• Lead cross-functional teams on CAPA projects.
• Present investigation findings to key stakeholders.

Skills

Problem solving ability

Interpersonal communication

Critical thinking

Education

B.S. and/or M.S. in Chemistry or Biology

Job description

Senior Manager, Quality Assurance Specialist

Join to apply for the Senior Manager, Quality Assurance Specialist role at Bristol Myers Squibb

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. Take your career farther than you thought possible.

Key Responsibilities

• Identify opportunities for process improvements by analyzing current workflows, systems, and procedures related to CAPA management.
• Lead cross-functional teams to drive process improvement projects from inception to completion.
• Manage the CAPA process, including the identification, investigation, and resolution of non-conformances.
• Act as a CAPA lead investigator to conduct and manage root cause analysis, perform impact assessment of GCP deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches.
• Act as a subject matter expert (SME) to support the business develop robust CAPAs with adequate effectiveness checks resulting from deviations, audits (investigator sites, protocols, process, vendors, systems, and others as required), inspections, quality events and serious breaches.
• Presents investigation findings to key stakeholders across Global Drug Development (GDD) and/or Global Quality (GQ) and works with the business to track CAPAs & effectiveness checks (where relevant) to completion.
• Provide training and support to staff on process improvement methodologies and CAPA management.
• Monitor the effectiveness of implemented CAPAs and process improvements through data analysis and performance metrics.
• Uses Quality Risk Management and Operational Excellence principles to facilitate risk-based decision-making, to drive continuous improvement, and to streamline processes.
• Stay current with industry best practices and regulatory requirements related to process improvement and CAPA management.
• Develops CAPA metrics and trend analysis to identify areas of improvement and drive continuous improvement.
• Prepare and present reports on process improvement activities and CAPA status to senior management.
• Serve as the Infinity system superuser and provide training to users, as needed.
• Maintains strong and productive working relationships with key stakeholders throughout BMS with the ability to think enterprise wide.
• Fosters Teamwork and Inclusion: Practices inclusion and seeks different perspectives. Builds effective teams committed to organizational goals; fosters inclusion and collaboration among teams to address relevant issues.
• Commitment to Quality: Emphasizes the need to deliver quality products and/or services; defines standards for quality and evaluates products, processes and/or services against those standards; manages quality.
• Recognize Global Implications and diversity: Seeks to understand issues, trends and perspectives of various cultures and countries; recognizes that what works in one's own country will not necessarily work in another; addresses cultural and geographic differences in strategies and approaches.
• Demonstrates Adaptability: Handles day-today work challenges confidently; is willing and able to adjust to multiple demands, shifting priorities, ambiguity and rapid change; show resilience in the face of constraints, frustrations or adversity; demonstrates flexibility.
• Analysis of Issues: Gathers relevant information systematically; considers a broad range of issues or factors; grasps complexities and perceives relationships among problems or issues; seeks input from others; uses accurate logic in analyses.
• Innovation: Generates new ideas; goes beyond the status quo; recognizes the need for new or modified approaches; brings perspectives and approaches together combining them in creative ways. Other:

Qualifications & Experience

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
• Minimum 7+ years GxP CAPA Management in Quality, Clinical Development or Regulatory Compliance.
• Advanced Finding Investigation and Root Cause Analysis (RCA) proficiency.

Required Competencies: Knowledge, Skills, and Abilities

• In-depth knowledge of GCP guidelines (e.g. ICH, FDA regulations), principles of Quality Assurance, and proven experience within Clinical Trial Execution (e.g. prior experience as CRA or Clinical Trial Manager).
• Demonstrated problem solving ability and quality mindset.
• Good interpersonal, oral and written technical communication skills are essential.
• Drives for results and success; conveys sense of urgency and drives issues to closure; persists despite any obstacles.
• Ability to work in a highly matrixed and complex environment.
• Demonstrates strong critical thinking skills and ability to make ethical, scientifically sound recommendations or decisions for issues consistent with company policy, regulatory references, and business strategy.
• Experience in leading investigations utilizing formal Root Cause Analysis tools is preferred (or the ability to obtain formal RCA training).
• Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Experience using data analytics (i.e. control charts, heat maps, histograms, box plots). Considers global influences, situations, and implications when making plans or decisions, solving problems developing strategies.
• Fosters a culture in which people continually work to improve services, and work processes.
• Maintains the confidentiality and security of information, data, documents, and records.
• Escalates issues to appropriate people within department/organization.
• Sense of diplomacy and discretion.
• Fluent in English, with proven professional working proficiency in English for reading, writing and speaking.

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

We are committed to ensuring a diverse workforce. You can apply at careers.bms.com

Equal Employment Opportunity Statement Bristol Myers Squibb is an Equal Employment Opportunity/Disability Employment/Harassment/Retaliation Employer. Our mission is to help patients succeed. The job function is in the drug manufacturing chain, high risk, high critical, high upside or high project. We look for candidates that come with experience, skills, knowledge, or professional training. The location is in Los Angeles County. For all applicants, we encourage you to apply anyway. You can apply at careers.bms.com

For much of the world we have a safe and a regulated environment. All people can decide what to learn from what you see. USA: California residents see additional requirements and clinical eligibility required. If you are a new find with a new outline, you can apply again.  Apply at: https://careers.bms.com/california-residents/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.