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Associate Director Quality

Iqvia
IQVIA
12+ years
preferred by company
Hyderabad, Remote, India, India
1 May 18, 2026
Job Description
Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding

Associate Director Quality – Client Dedicated Process & Quality Documentation Manager

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

About the Opportunity

A leading global clinical research and healthcare intelligence organization is hiring an experienced Associate Director Quality – Client Dedicated Process & Quality Documentation Manager for its Hyderabad-based operations. This senior leadership opportunity is ideal for professionals with extensive expertise in clinical development, quality management systems, regulatory compliance, process optimization, and documentation governance within pharmaceutical, biotech, or CRO environments.

This role is designed for professionals who can drive process excellence, manage global quality documentation frameworks, support audits and inspections, and collaborate with international cross-functional teams to ensure operational compliance and efficiency.

Key Responsibilities

Process Management & Business Process Excellence

  • Lead and support end-to-end process design, process mapping, and workflow optimization across global clinical development operations.
  • Collaborate with business process owners to develop and update standardized operating procedures and quality documentation.
  • Ensure compliance with documentation governance standards, process simplification principles, and regulatory frameworks.
  • Create and revise process flow diagrams using industry-standard process design tools.

Quality Documentation Management

  • Manage development, review, revision, and continuous improvement of controlled quality documents and managed information.
  • Maintain compliance with document review timelines and regulatory quality standards.
  • Coordinate documentation approvals and stakeholder collaboration across departments.
  • Oversee managed information repositories and document lifecycle management processes.
  • Represent quality documentation governance in cross-functional development excellence initiatives.

Training Coordination & Compliance Oversight

  • Maintain training matrices for internal teams.
  • Coordinate role-based training assignments and compliance tracking.
  • Work with training representatives to improve learning assignment processes and operational readiness.

Audit & Inspection Support

  • Support preparation for internal audits, regulatory inspections, and client quality reviews.
  • Assist in audit response planning and corrective/preventive action follow-ups.
  • Ensure timely closure of CAPA commitments and quality observations.

Required Qualifications

  • Advanced degree in Life Sciences, Pharmacy, Biology, Chemistry, Clinical Research, or related discipline
  • Minimum 12 years of experience in clinical development, pharmaceutical industry, CRO, or equivalent healthcare research environment
  • Minimum 5 years of direct sponsor-CRO collaboration experience for global clinical trials
  • Proven experience managing cross-functional international teams
  • Strong leadership and people management experience
  • Deep understanding of:
    • ICH Guidelines
    • Good Clinical Practice (GCP)
    • SOP Management
    • Quality Management Systems
    • Regulatory Compliance
    • Clinical Documentation Governance

Preferred Skills

Candidates with the following experience will be highly preferred:

  • Document management systems expertise
  • Process design tools such as iGrafx
  • GCP audit and inspection support experience
  • Advanced Microsoft Office proficiency
  • Strong stakeholder management and negotiation skills
  • Strategic problem-solving and decision-making abilities
  • Experience working in matrix organizational structures

Who Should Apply

This position is best suited for:

  • Senior Clinical Quality professionals
  • Quality Documentation Managers
  • Clinical Operations Leaders
  • Regulatory Compliance Specialists
  • Process Excellence Managers in Life Sciences
  • Global Clinical Development Leaders