What if the work you did every day could impact the lives of people you know? Or all of humanity?At Illumina, we are expanding access to genomic technology to realize health equity for billions of people around the world. Our efforts enable life-changing discoveries that are transforming human health through the early detection and diagnosis of diseases and new treatment options for patients.Working at Illumina means being part of something bigger than yourself. Every person, in every role, has the opportunity to make a difference. Surrounded by extraordinary people, inspiring leaders, and world changing projects, you will do more and become more than you ever thought possible.
We are seeking a highly skilled and experienced Functional Manager to oversee the Clinical, Quality, Medical, and Regulatory Affairs (CQMR) GIS India Team. This role will also entail responsibilities as a Staff Business Systems Analyst for SAP Quality Management (QM) and Quality Management Systems (QMS). The ideal candidate will possess strong leadership abilities, technical expertise, and a keen understanding of the regulatory landscape.
Key ResponsibilitiesFunctional 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 R&D, 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.
Illumina believes that everyone has the ability to make an impact, and we are proud to be an equal opportunity employer committed to providing employment opportunity regardless of sex, race, creed, color, gender, religion, marital status, domestic partner status, age, national origin or ancestry, physical or mental disability, medical condition, sexual orientation, pregnancy, military or veteran status, citizenship status, and genetic information.
