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Associate Director Quality

Iqvia
IQVIA
12+ years
preferred by company
Mumbai, Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding

Associate Director Quality – Client Dedicated Process & Quality Documentation Manager

Location: Mumbai, India
Job Type: Full-Time
Work Mode: Home-Based / Remote
Industry: Pharmaceutical | Clinical Research | CRO | Life Sciences
Experience Required: 12+ Years (Freshers Not Eligible)
Job ID: R1542017

Job Overview

A leading global healthcare and clinical research organization is hiring an experienced Associate Director Quality – Client Dedicated Process & Quality Documentation Manager for its Mumbai operations. This senior leadership role is ideal for professionals with strong expertise in clinical quality management, process excellence, regulatory documentation, audit readiness, GCP compliance, and pharmaceutical operations.

The selected candidate will lead quality documentation governance, process design optimization, audit support activities, training oversight, and cross-functional compliance initiatives within global development operations.

This opportunity is best suited for senior professionals from pharmaceutical companies, CROs, biotechnology organizations, and clinical development environments seeking leadership growth in global quality operations.

Key Responsibilities

Process Design & Process Excellence Management

  • Support and guide business process owners in developing, improving, and maintaining end-to-end operational processes.
  • Lead process mapping, workflow optimization, and process documentation initiatives.
  • Ensure process frameworks align with internal quality standards, regulatory expectations, and documentation governance requirements.
  • Create and revise process flow diagrams using approved process design methodologies and enterprise tools.
  • Drive harmonization, simplification, and standardization across global development operations.

Quality Documentation Management

  • Manage creation, review, maintenance, revision, and lifecycle governance of controlled documents and managed information records.
  • Ensure documentation complies with regulatory standards, formatting requirements, and organizational quality policies.
  • Coordinate document approvals with cross-functional stakeholders and document owners.
  • Maintain document governance systems and managed information repositories.
  • Support ongoing improvement of quality documentation frameworks.

Training Management & Compliance Coordination

  • Maintain training assignment matrices for internal teams.
  • Coordinate learning compliance activities with training representatives.
  • Ensure employees receive appropriate quality and process training aligned with operational roles.

Audit, Inspection & CAPA Support

  • Assist in internal audits, external inspections, and compliance reviews.
  • Coordinate audit response documentation and corrective/preventive action tracking.
  • Ensure CAPA commitments are monitored and completed within agreed timelines.
  • Support inspection readiness across assigned quality functions.

Cross-Functional Leadership

  • Represent quality documentation governance in internal excellence councils and cross-functional review boards.
  • Collaborate with international teams across quality, operations, regulatory, and development functions.
  • Drive communication and alignment between stakeholders in matrix environments.

Eligibility Criteria

Educational Qualification

  • Advanced degree in Life Sciences, Pharmacy, Biology, Chemistry, Clinical Research, Biotechnology, or equivalent discipline

Experience Requirements

  • Minimum 12 years of experience in clinical development, pharmaceutical operations, CRO environments, or related healthcare industries
  • Minimum 5 years of direct sponsor-CRO collaboration experience in global clinical trials
  • Proven leadership experience managing teams or cross-functional international projects
  • Experience across multiple clinical development functions preferred

Required Skills

  • Clinical Quality Management
  • Good Clinical Practice (GCP)
  • International Conference on Harmonisation (ICH) Guidelines
  • Standard Operating Procedures (SOP) Management
  • Regulatory Compliance
  • Controlled Documentation Management
  • CAPA Management
  • Audit & Inspection Readiness
  • Process Improvement
  • Stakeholder Management
  • Team Leadership
  • Microsoft Office
  • Problem Solving
  • Decision Making
  • Cross-Functional Collaboration
  • Business Process Mapping