Job Description

About Leading-Biotechnology-CompanyANSR, a market leader in enabling organizations to build, manage and scale global teams, is partnering with a renowned biotechnology company who is redefining the future of human health by providing solutions to some of the most complex problems in the healthcare industry. They are committed to making precision medicine accessible and carries out their business operations in an environmentally sustainable way.Now is your opportunity to join their innovative team in Bengaluru, India. For over 20 years now, companies cutting across size, industry and markets have relied on ANSRs expertise to successfully build global business and technology teams. We can help you land a rewarding career in this dynamic industry.If you are eager to contribute to a company with strong values, a supportive environment and where you get opportunities to work on challenging projects that uses cutting-edge technology to improve millions of lives, this is your chance to join a truly remarkable team. Apply today!About Illumina:Illumina is a leading developer, manufacturer, and marketer of life science tools and integrated systems dedicated to making genomics useful for all. Illuminas integrated Indian global hub in Bengaluru, Illumina India Biotechnology Private Limited, is focused on technology activities that will help usher in the next wave of innovation in healthcare and medical research. If youre eager to work on challenging projects that uses cutting-edge technology to transform the future of healthcare, this is your chance to join a truly remarkable team.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 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 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:

• Bachelors 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.

Experience / Education:

• Typically requires a Bachelors degree and a minimum of 8 years of related experience, with 1-3 years of Management experience.

Leading-Biotechnology-Company