Digital Quality & Compliance (Life Sciences)
Location: Pan India
Who You'll 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.
Key Responsibilities
- 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.
Technical Skill
- 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
- Bachelor's degree in Life Sciences, Business, or related field; MBA preferred (top‑tier B‑school).
- 5–13 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.
