Digital Quality & Compliance (Life Sciences)

Manufacturing and Quality Data Expert (Life Sciences)

Location: Bengaluru/Hyderabad

Who Youll Work With

We partner with leading global BioPharma and Med‑Tech organizations on transformation initiatives across the value chain, including Data‑Driven R&D, Clinical Development, Intelligent Operations, Digital Transformation, Quality & Regulatory Compliance, and Connected Health.

You will work closely with C‑Suite executives and senior leadership to design and deliver complex, high‑impact transformation programs.

What Youll Do

• Assess current quality state and define digital quality strategies and roadmaps.
• Develop and implement quality strategies and SOPs (Data Governance, IT QMS, Change Control, Non‑Conformance, CAPA).
• Resolve complex quality and compliance challenges using data‑driven insights.
• Drive continuous improvement and compliance with GMP, FDA, and ISO standards.
• Enable quality transformation using automation, analytics, AI, and digital platforms.
• Design Digital Quality Operating Models, define KPIs, and lead improvement engagements.
• Provide expertise in GxP validation, SDLC, Agile methodologies, and ALCOA+ data lifecycle management.
• Advise stakeholders on quality systems, compliance, and digital enablement.

What Were Looking For

• Strong understanding of life sciences regulations and industry trends.
• Experience across multiple areas such as:
• Digital QMS implementations (Veeva, MasterControl, TrackWise, EtQ, ComplianceWire)
• GxP Compliance, Regulatory Affairs, Audits, Periodic Reviews
• MES / Manufacturing IoT, Analytics, Big Data
• Process Improvement, Risk Management, Automated Controls
• End‑to‑End Validation (CSV/CSA) for ERP, CRM, LIMS, AI/ML, IoT, Cloud, and Digital Health
• Excellent problem‑solving, communication, stakeholder management, and business development skills.

Education & Experience

• Bachelors degree in Life Sciences, Business, or related field; MBA preferred (top‑tier B‑school).
• 6-9 years of experience in life sciences quality systems consulting or relevant industry roles.
• Strong techno‑functional expertise in quality systems, data management, and IT validation.
• Deep understanding of FDA, EMA, MHRA and standards such as ISO, IMDRF, PIC/S.
• Certifications such as Lean Six Sigma, ASQ, CPSM, RAC are a plus.

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