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Associate Director Quality

Iqvia
IQVIA
12+ years
preferred by company
Remote, India, Thane, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Medical Billing, Medical Coding, Medical Terminology, mRS and EQ-5D-5L., Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Director Quality – Client Dedicated Process & Quality Documentation Manager

Location: Thane, 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 Reference ID: R1542017

About the Role

A globally recognized clinical research and healthcare solutions organization is seeking an experienced Associate Director Quality – Client Dedicated Process & Quality Documentation Manager for its Thane-based operations. This is a senior leadership opportunity for highly experienced professionals with expertise in clinical quality assurance, process governance, quality documentation management, audit readiness, regulatory compliance, and cross-functional clinical operations leadership.

The ideal candidate will play a strategic role in strengthening process excellence, ensuring documentation compliance, supporting global audits, managing training governance, and improving quality frameworks across development operations.

This opportunity is ideal for professionals from pharmaceutical companies, biotechnology organizations, contract research organizations (CROs), and global clinical development environments.

Key Responsibilities

Process Excellence & Business Process Management

  • Support and guide business process owners in developing, enhancing, and maintaining end-to-end operational processes.
  • Lead process design, process mapping, workflow optimization, and documentation standardization initiatives.
  • Ensure adherence to global documentation governance standards, regulatory compliance expectations, and quality frameworks.
  • Develop and update process flow diagrams using approved enterprise process management tools.
  • Drive simplification, harmonization, visualization, and operational efficiency improvements.

Quality Documentation Governance

  • Oversee the development, review, revision, maintenance, and continuous improvement of controlled quality documents and managed information assets.
  • Ensure timely review and renewal of documentation to maintain regulatory compliance.
  • Coordinate documentation workflows with process owners and cross-functional stakeholders.
  • Maintain document governance systems and information repositories.
  • Ensure document formatting, content integrity, and quality compliance standards are consistently followed.

Training Governance & Compliance Coordination

  • Manage organizational training matrices and role-based learning assignments.
  • Coordinate training governance with internal quality and training representatives.
  • Support compliance-driven workforce readiness initiatives.

Audit, Inspection & CAPA Management

  • Support audit preparation, regulatory inspections, and quality compliance assessments.
  • Coordinate audit responses and follow-up documentation activities.
  • Track corrective and preventive action (CAPA) commitments to ensure timely closure.
  • Strengthen inspection readiness across quality functions.

Cross-Functional Leadership

  • Represent quality documentation governance in internal development excellence and quality review forums.
  • Collaborate with global stakeholders across quality, regulatory, operations, and clinical development teams.
  • Drive communication, governance alignment, and process consistency in matrix environments.

Required Qualifications

Educational Requirements

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

Professional Experience

  • Minimum 12 years of experience in pharmaceutical, clinical research, CRO, or clinical development environments
  • Minimum 5 years of direct sponsor-CRO interaction experience in global clinical trial environments
  • Demonstrated leadership experience managing teams or complex cross-functional global initiatives
  • Experience across multiple clinical development or quality functions preferred

Core Skills Required

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

Preferred Candidate Profile

Professionals with the following additional expertise will be preferred:

  • Experience with document management systems
  • Exposure to process design tools such as iGrafx
  • Experience supporting GCP audits and inspections
  • Background in global pharmaceutical quality governance
  • Strong negotiation and communication capabilities