Life Science Consultant, Business Analyst

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At KVALITO Consulting Group, a woman-owned business founded in 2013, we are dedicated to transforming the life sciences and healthcare sectors through tailored, innovative solutions that prioritize quality and people. Guided by our vision to lead with talent and transform with purpose, we are committed to creating lasting, high-value relationships with our clients and empowering high-performing individuals to reach their full potential.
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If you're passionate about making a difference and eager to grow within a company that values inclusivity and high performance, KVALITO could be the place for you. Join us in creating transformative solutions that empower our clients and leave a legacy of excellence in consulting.
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Life Science Consultant, Business Analyst (Lab Informatics)

Position: Life Science Consultant, Business Analyst (Lab Informatics)
Location: Remote, India
Type: Full-Time

About the Role
We are seeking an experienced Business Analyst with a strong background in GxP-regulated environments to support validation and vendor activities for scientific instrument platforms and data management systems. The ideal candidate will act as a bridge between business stakeholders, technical teams, and vendors, ensuring that requirements are accurately translated into validated solutions.
This role requires both domain expertise in CSV and regulatory compliance as well as the ability to engage with scientists, IT teams, and external vendors to drive business outcomes.

Key Responsibilities

• Gather, analyze, and document business requirements from scientific and business stakeholders.
• Support validation activities (CSV - Computer System Validation) including URS, FS, IQ/OQ/PQ, traceability, and UAT.
• Collaborate with vendors to align solutions with business needs and compliance requirements.
• Map and visualize processes using Microsoft Visio and other documentation tools.
• Ensure system implementations meet GxP, 21 CFR Part 11, and other regulatory standards.
• Translate complex business needs into clear technical requirements for IT and vendor teams.
• Act as a liaison between end users, IT teams, and quality/compliance teams.
• Contribute to risk assessments, change control, and regulatory documentation.

Key Skills & Requirements

• Minimum 5 years as a Business Analyst, ideally within pharma, biotech, or medical device environments.
• Strong knowledge of GxP, CSV, and regulatory compliance (FDA, EMA, 21 CFR Part 11, ICH-GCP).
• Experience with lab informatics and instrument platforms such as:

• Polar (IDBS)
• Revvity Signals
• TetraScience Instrument Connection Platform
• CDS (Chromatography Data Systems)

• Proficiency in process mapping and workflow design (Visio or similar).
• Strong stakeholder management and communication skills - ability to translate business needs into validated technical solutions.
• Familiarity with Agile methodologies (JIRA, Azure DevOps, or similar tools).

Preferred Qualifications

• Previous experience working in pharmaceutical R&D, lab operations, or regulated IT projects.
• Hands-on involvement in vendor coordination, UAT, and system validation projects.
• Knowledge of data management, integration, and API-based system connectivity in lab environments.
• Bachelor's or Master's degree in Life Sciences, Engineering, IT, or related field.

Key Competencies:

• Strong communication and stakeholder engagement skills.
• Detail-oriented with a proactive, solution-driven mindset.
• Capable of working independently in a remote, global team environment.
• Structured, strategic thinker with hands-on execution ability.
• Comfortable managing timelines, reporting progress, and driving issue resolution.

You:

• Are driven by impact, passionate about shaping the future of Life Sciences and healthcare through technology and innovation.
• Believe in open communication, speak up, challenge ideas, and engage in meaningful discussions, even with leadership.
• Focus on solutions, not problems, take a proactive approach, looking for ways to improve rather than assigning blame.
• Own your work, take responsibility and accountability seriously, no matter how challenging the situation.
• Commit to excellence, delivering high-performance results while embracing sustainable practices in everything you do.

We:

• Strive to be the best; our mission is to become the world's leading consulting company, empowering high-performing individuals, regardless of gender or neurotype, to reach their full potential and leave a legacy of diversity, equality, inclusion, and excellence.
• Foster a culture of respect, value integrity, fairness, and the unique contributions of every team member.
• See mistakes as opportunities, embrace challenges, learn from them, and continuously improve.
• Prioritize potential over experience, believe intelligence, values, and growth matter more than the number of years on a résumé.

We believe in potential, values, and growth , so if this role excites you, let's connect
Your KVALITO Team.