Key Responsibilities Functional Manager - CQMR GIS Team
- Team Leadership: Provide guidance and direction to the CQMR GIS team, ensuring alignment with organizational goals and fostering a collaborative work environment. Be the Manager at the India office for the CQMR team.
- Strategic Planning: Develop and implement strategic plans to enhance the efficiency and effectiveness of CQMR operations.
- Stakeholder Engagement: Collaborate with cross-functional teams, including RD, manufacturing, quality, and compliance, to ensure cohesive and integrated approaches to CQMR initiatives.
Staff Business Systems Analyst - SAP QM and QMS Systems
- System Analysis and Design: Analyze business requirements and translate them into technical specifications for SAP QM and QMS systems.
- Implementation and Support: Lead the implementation, configuration, and ongoing support of SAP QM and QMS systems to meet business needs.
- Process Improvement: Identify opportunities for process optimization within SAP QM and QMS, driving continuous improvement initiatives.
- Verification and Validation - Write test scripts/protocols (IQ, OQ, PQ), test execution and execute protocols. Documentation on Knowledge Base articles like Troubleshooting Articles, Quick Reference Guide , etc
- Training and Documentation: Assist in the Development and Delivery of training programs for end-users, and create comprehensive documentation for system processes and enhancements.
- Issue Resolution: Troubleshoot and resolve system issues, ensuring minimal disruption to business operations.
Qualifications
- Education: Bachelor s degree in Information Systems, Business Administration, or a related field. Advanced degree preferred.
- Experience: Minimum of 7 years of experience in a similar role, with a strong focus on SAP QM and QMS systems.
- Technical Skills: Proficiency in SAP QM, QMS, and related business systems. Experience with system integration and data analysis.
- Leadership: Proven track record of leading teams, managing projects, and driving strategic initiatives.
- Communication: Excellent verbal and written communication skills, with the ability to engage and influence stakeholders at all levels.
- Problem-Solving: Strong analytical and problem-solving abilities, with a focus on delivering practical solutions.
- Regulatory Knowledge: Familiarity with industry regulations and standards related to clinical, quality, medical, and regulatory affairs.
- Time Zone Flexibility: Ability to work overlap with US-based time zones to facilitate effective communication and collaboration with global teams.
Key Competencies
- Leadership and Mentoring: Ability to inspire and develop team members, fostering a culture of continuous learning and improvement.
- Strategic Thinking: Capacity to think strategically and develop long-term plans that align with organizational objectives.
- Collaboration: Strong collaborative skills with a demonstrated ability to work effectively in a cross-functional team environment.
- Adaptability: Flexibility to adapt to changing business needs and priorities, while maintaining focus on key objectives.
- Attention to Detail: Meticulous attention to detail, ensuring accuracy and compliance in all deliverables.
