Sr Manager - Quality Control (QMS Lead)

Rubicon Research; Mumbai, Ambernath; Sur place; INR 2 500 000 - 4 000 000; Plein temps

Résumé du poste

Rubicon Research in Mumbai is seeking a Senior Manager to lead a 10+ member QMS team responsible for planning and executing QMS activities to ensure timely closure of records and audit readiness.

You will drive root-cause investigations for laboratory events, manage incidents and deviations, and coordinate cross-functionally with R&D, QA, Production, Engineering, and Regulatory Affairs to defend data during major audits such as USFDA and MHRA.

Qualifications

• Senior leadership experience in QC-QMS environments.
• Experience defending laboratory investigations during regulatory audits.
• Strong understanding of GLP and ICH principles.

Responsabilités

• Lead a team of 10+ QMS reviewers to ensure timely completion of tasks with minimal supervision.
• Oversee end-to-end QMS activities including incidents, deviations, change controls, file notes, and ratifications.
• Manage investigations for OOS and OOT results and conduct root-cause analyses.

Connaissances

Leadership

Regulatory knowledge

Investigation skills

Data integrity

Cross-functional collaboration

Formation

MSc in Chemistry

M.Pharm

Outils

TrackWise

LIMS

Documentum

Description du poste

Role & responsibilities

Purpose

To lead a team of 10+ QMS Reviewers in planning, monitoring, and executing all QC quality management systems to ensure timely closure of records. This role drives robust root cause investigations for laboratory events and maintains the department in a perpetual state of regulatory audit readiness.

Responsibilities

• Lead, mentor, and monitor a team of approx. 10+ QMS Reviewers to ensure daily tasks are completed with minimal supervisor support.
• Oversee the end-to-end lifecycle of QMS activities including incidents, deviations, change controls, file notes, and ratifications.
• Manage comprehensive laboratory investigations for Out of Specification (OOS) and Out of Trend (OOT) results.
• Conduct thorough root-cause analysis using structured tools like 5-Why, Fishbone diagrams, and Fault Tree Analysis.
• Enforce and execute effective Corrective and Preventive Actions (CAPA) to ensure timely closure of QMS records within defined timelines.
• Coordinate cross-functionally with R&D, QA, Production, Engineering, Warehouse, Validation, and Regulatory Affairs to resolve complex quality events.
• Arrange and manage laboratory resources effectively to guarantee smooth line functions and operational continuity.
• Oversee the rigorous review of analytical raw data for correctness and completeness prior to final submission to QA.
• Front-face international regulatory and client audits (USFDA, MHRA, etc.) for all section-related QMS workflows.
• Ensure all QMS documentation remains fully compliant, completed online, and continuously inspection-ready.
• Drive strict compliance with Good Laboratory Practices (GLP) and Health, Safety, and Environment (HSE) systems in the lab.
• Execute additional technical or strategic tasks assigned by senior leadership to support business objectives.

Required Skills

• Investigation Expertise: Proficient in structural root cause analysis tools (Fishbone, 5-Why) and writing tight, technical OOS investigation reports.
• Regulatory Compliance: Deep understanding of global guidelines (USFDA, MHRA, ICH, WHO) and data integrity principles.
• Analytical Mindset: Strong understanding of QC workflows, chromatography data systems, and raw analytical data review.
• Leadership Stature: Excellent team management capabilities to guide 10+ reviewers and handle cross-functional conflicts effectively.
• Communication: Superior technical writing skills and verbal communication needed to confidently defend data during regulatory audits.

Preferred Candidate Details

• Education & Experience: Regular M.Sc (Chemistry) or M.Pharm with 15 to 20 years of experience in regulated pharma QC environments.
• Current Profile: Currently working as a Senior Executive, Team Lead, or Manager specifically managing QC-QMS compliance and investigations.
• Team Leadership: Proven track record of managing a direct team of at least 8 to 10 technical reviewers or analysts.
• Audit Exposure: Must have face-to-face experience defending laboratory investigations during major regulatory audits like USFDA or MHRA.
• System Knowledge: Highly proficient in handling electronic quality management platforms (such as TrackWise, LIMS, or Documentum).