Senior Quality Assurance Auditor

Cenduit provides interactive response technology (IRT) - driven services for clinical trials around the world. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and clinical supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific. Cenduit's Software as a Service (SaaS) IRT solutions deliver optimized clinical supply chain management and facilitate precise control over patient randomization and drug administration to enable more efficient, compliant trials. With expert personnel located across the globe, Cenduit's unprecedented level of support currently covers more than 32,000 sites in more than 100 countries.

Overview:
The Senior Quality Assurance Auditor will support the QA organization in achieving the strategic goals as
identified in the yearly strategic plan. This will be accomplished via supporting and maintaining all aspects of the Quality System in accordance with the company's quality manual, SOPs, and customer requirements. Taking on a leadership role in process definition or re-engineering for continuous improvement of operating procedures and processes. Providing value-added, day-to-day support, guidance, and direction to the operational teams on matters of regulatory and process compliance in service of clinical trials. Performing and supporting regular audits at assigned locations.
Primary Responsibilities:

  • Serve as main QA contact and localized escalation point for all issues arising from assigned locations. Provide guidance and direction to key operational and delivery stakeholders in matters of compliance and best practice.
  • Assist in the development, implementation, and maintenance of Cenduit's Quality System, including facilitating process improvement activities to the product and project teams for continuous improvement.
  • Host customer audits as needed. Participate/support whenever required.
  • Perform internal audits to ensure that Quality Standards are being adhered to.
  • Conduct ongoing training and support for new and existing staff on the Quality Manual and other key areas including Corporate SOPs, GCP, 21 CFR Part 11, validation, and process improvement/problem solving.
  • Assist in the maintenance of the corrective/preventive action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports and metrics.
  • Participates in the evaluation of quality events, incidents and possible complaints or compliments and the follow-up events.
  • Task management of assigned initiatives. May assume line management responsibilities as needs and experience dictate.
  • Keep up to date with all related quality legislation and compliance issues.
  • Represent the company during external inspections as required.
  • Perform Vendor Evaluation / Vendor audits as required.
  • Liaise with customers and suppliers where necessary (where impacting/affected by quality issues).
Skills:
  • Comprehensive understanding of quality management systems initiatives and standards, including experience in writing policies and procedures.
  • Intermediate expertise with computerized systems validation methodologies and related industry expectations.
  • Experience in conducting and/or hosting audits of computerized systems with clinical trial relevance.
  • Established client facing communication skills - ability to manage situations, negotiate conflicts, and influence others to achieve objectives.
  • Empowered to make decisions with occasional or minor supervision. Critical items to be escalated for consideration.
  • Experience with process improvement, integration, and/or problem solving practices.
  • Ability to promote quality culture throughout the Cenduit Global business.
Education and Experience:
  • Bachelor's degree or equivalent
  • 3-7 years experience working within a regulated environment. Experience with FDA and international regulations such as 21 CFR Part 11, GCP/E6, EU Directive 95/46/EC, etc. is preferred.
  • 2-5 years experience in Quality Assurance role in a regulated environment or ISO 9000 certified company.
  • Prior task and/or line management experience helpful.


The role requires international travel as needed to support audits and business needs.

Cenduit offers equal employment opportunities without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity, national origin, age, disability, genetic information, veteran or military status and other protected class characteristics.


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