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.
Top Skills
What We Do
RCM&D is ranked among the top independent insurance advisory firms in the United States. Our specialized teams provide strategic solutions and consulting for risk management, insurance and employee benefits. Leveraging more than 135 years of experience and strong local, national and global reach, we partner with you to meet all of your business objectives.
RCM&D Self-Insured Services Company (SISCO) is a Third Party Administrator and a trusted partner in claim management, consulting and advisory services for clients that are self-insured, fully insured, or utilize captive or high deductible programs. Our expertise coupled with our technological resources ensure budget certainty, reduced costs and the overall efficiency of your claim process.
Established in 2020 through the strategic merger of RCM&D and Oswald Companies, Unison Risk Advisors (a dba of the JBO Holding Company) is majority employee owned. On June 20, 2023, NSI became the third partner of Unison Risk Advisors. Unison Risk Advisors is made up of these three primary operating companies and all their existing subsidiaries and sub-brands. Today it is one of the largest privately held and employee-owned insurance brokerage and risk management firms in the U.S.
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