Associate Director Quality - Client Dedicated Process & QD Manager

IQVIA•Durham, NC

38d

About The Position

The Associate Director Quality - Client Dedicated Process & QD Manager performs various activities in support of process elaboration, design/mapping, documentation (controlled documents and managed information documents) 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

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.

Nice To Haves

Document management experience
iGrafx/process design experience
GCP audit/inspection support experience

Responsibilities

Supports/guides BPOs in the process to develop or update process design (end-to-end Process design including set-up expectations, perform Elaboration Workshop and coordinate Cross-functional Alignments, Document Authoring responsibilities)
Ensures adherence to R&D documentation standards, process orientation, simplification, visualization, harmonized core language, regulatory compliance and harmonization of processes and QDs within GDO
Develops/revises process flow diagrams using the designated system and notation standards and supports the GDO organization as an expert for efficient process design and illustration
Responsible for the development, review/revision, maintenance and continuous improvement of Quality Documents (incl. CDs and MIs) for GDO
Ensures timely review/revision of existing processes & QDs within GDO, maintaining compliance with review/renewal timelines
Owns GDO Managed Information Document ManGo Cabinet
Coordinates review and revision of documents with all appropriate stakeholders in cooperation with the process/document owner
Ensures compliance with document content and formatting standards
Represents GDO in Merck Healthcare R&D Development Excellence Council (DEC) and manages related activities
Ensures timely and adequate communication on behalf of the DEC to the GDO organization
Maintains training matrix, coordinates training roles, and works with Training Representatives to optimize assignments in GDO
Supports the preparation, coordination, and response for audits and inspections, as appropriate to area of responsibility