Associate Director, QA (R1115144) in Warsaw, PL at IQVIA™

Date Posted: 2/4/2020

Job Snapshot

  • Employee Type:
  • Location:
    Warsaw, PL
  • Experience:
    Not Specified
  • Date Posted:
  • Job ID:

Job Description

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

This role can be home based and located in any Eastern Europe location.

This position is an Associate QA Director in the Customer Strategy team who will serve as the strategic quality engagement lead for one or more key (i.e. accounts with established governance structures, account directors and multiple projects)  IQVIA customers.  The SEL role includes the following activities for the assigned customers: 

Role Responsibilities
• Collaborates with Quality counterparts at customers and with internal project teams to proactively promote, support and facilitate proactive quality through the identification and management of risks and implementation of quality improvement activities.
• Provides actionable insights from quality and operational data analysis and proactively working with the customer and the account team to develop action plans to drive continuous improvement. 
• Analyzes trends in quality issue reporting and timeliness to ensure adherence to quality issue management requirements across project teams 
• Supports the management and resolution of significant issues relating to quality;
• In collaboration with Quality Management, ensures projects are inspection ready starting at the design stage.
• Drives inspection readiness activities for the customer, including contributing to mock inspections by/of the customer
• Contributes to the development of the global risk-based internal audit plan.
• Advises customer Quality counterparts on the strategy for regulatory inspections and collaborates in the preparation for and management of inspections at customer offices and, as necessary, at investigator sites.
• Prepares for and actively participates in relevant Governance/partnership level meetings e.g. Quality Councils/ Joint Operations Committee (JOC) or equivalent meetings with customer Quality counterparts.
• Interfaces with senior management to discuss quality and compliance issues
• Interfaces with business development and operations to identify business opportunities
• Hosts and/or supports customer audits and ensures appropriate and sustainable action plans are developed and implemented.

Skills and Experience

  • 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including  GXP Quality Assurance experience
  • Equivalent combination of education, training and experience 
  • Strong knowledge of pharmaceutical research and development processes and regulatory environments.
  • Considerable knowledge of quality assurance processes and procedures.
  • Strong interpersonal skills and the ability to positively influence and guide others
  • Excellent problem solving, risk analysis and negotiation skills.
  • Effective organization, communication, and team orientation and leadership skills.
  • Possess applicable experience in conducting audits, writing audit reports and analyzing audits.
  • Demonstrated ability to lead and manage multiple responsibilities.
  • Identify functional constraints and identify solutions.
  • Ability to coordinate timelines with internal customers and external vendors.
  • Ability to manage multiple activities and timelines.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Join Us

Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

Forge a career with greater purpose, make an impact, and never stop learning.

Job ID: R1115144


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