Associate Director, Quality – Client Dedicated Process & QD Manager

IQVIA

. Performs various activities in support of process elaboration, design/mapping, documentation development, review, formatting, and revision for GDO.

Posted 5/8/2026full-timeDurham • North Carolina • 🇺🇸 United StatesSenior💰 $94,900 - $264,200 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Performs various activities in support of process elaboration, design/mapping, documentation development, review, formatting, and revision for GDO.
Support focuses on ensuring that good process design principles and appropriate documentation standards are consistently applied, that activities are consistently and efficiently coordinated and that deliverables are completed in a high quality and timely manner.
Support may also be provided to coordinate audits and audit response processes and to ensure compliance with agreed CAPA due dates, as needed.
In addition, the Process & QD Manager is in charge of coordinating GDO training assignments, Managed Information and cross-functional QD reviews (incl. representation of GDO in DEC).

Requirements

What you’ll need

Advanced degree in Life Sciences (e.g., biology, chemistry, pharmaceuticals) or equivalent
Minimum 12 years of experience in clinical development in pharmaceutical industry or CRO or equivalent including at least 5 years direct involvement in sponsor – CRO interaction for global trials
Experience in different functions in the clinical development area
Experience as line manager and/or as leader of cross-functional virtual international teams
Requires deep knowledge of one or more related job areas typically obtained through advanced education combined with experience.
Sound working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
Excellent organizational, interpersonal and communication skills.
Excellent judgement and decision-making skills.
Demonstrated leadership and line management skills.
Excellent influencing and negotiation skills.
Strong computer skills including Microsoft Office applications.
Excellent problem-solving skills.
Demonstrated ability to work in a matrix environment.
Ability to lead and motivate a clinical team also required.
Ability to travel within the region/country.
Ability to establish and maintain effective working relationships with co-workers, managers and clients.
Fluent in English.

Benefits

Comp & perks

Health insurance
Retirement plans
Paid time off
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical developmentsponsor-CRO interactionquality management processesGood Clinical Practice (GCP)Standard Operating Procedures (SOPs)regulatory requirementsprocess designdocumentation developmentaudit coordinationCAPA compliance

Soft Skills

organizational skillsinterpersonal skillscommunication skillsjudgementdecision-making skillsleadership skillsline management skillsinfluencing skillsnegotiation skillsproblem-solving skills