Key Accountabilities:
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).
Key Role Responsibilities
Process Management (BPC role):
• 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
Controlled Document & Managed Information Document Management:
• 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
Training Management and Oversight:
• Maintains training matrix, coordinates training roles, and works with
Training Representatives to optimize assignments in GDO
Audits and Inspections:
• Supports the preparation, coordination, and response for audits and
inspections, as appropriate to area of responsibility
Qualifications and 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.
Preferred
• Document management experience
• iGrafx/process design experience
• GCP audit/inspection support experience
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.iqvia.com/eoe
IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.
The potential base pay range for this role, when annualized, is $94,900.00 - $264,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.