Quality Assurance Manager
Cenduit LLC is the largest IRT (interactive response technology) specialist in the world with the expertise to empower study sponsors for success by implementing a completely personalized system that puts them in control of their clinical trials. Cenduit was founded in May 2007 and emerges from a robust tradition of clinical development and supply chain expertise from two world leaders, Quintiles and Thermo Fisher Scientific.
Meeting the needs of investigator sites and patients, Cenduit offers clinical supply chain intelligence and clinical operations know-how through its IRT-driven services: rapid study start-up software, patient randomization (RTSM), patient reminders, drug supply management, and eClinical integration. Cenduit has over 500 experts worldwide in the US, UK, Switzerland, India and Japan, with clinical trial experience in more than 100 countries, interacting with more than 600,000 patients at more than 32,000 sites.
A QA Manager will support the QA organization in achieving the strategic goals. This will be accomplished via:
- Line management responsibilities and ensuring supporting staff are aligned and making progress towards defined goals.
- Supporting and maintaining all aspects of the Quality System in accordance with the company's quality manual, SOPs, and customer requirements.
- Taking on a management 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.
- Organization, performing and supporting regular audits at assigned locations.
- Serve as key escalation and QA contact globally with focus on assigned/regional office locations. Provide guidance and direction to key operational and delivery stakeholders in matters of compliance and best practice.
- Shared ownership 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.
- Ensures progress of related staff towards individual and departmental goals and initiatives and ensures staff qualifications remain current to defined standards.
- Assists in definition, execution, and reporting of department objectives and assigned initiatives.
- Proactive monitoring of compliance with Quality System reviews, Corrective And Preventive Actions, training, internal auditing, and supplier management.
- 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.
- Host customer audits as needed. Participate/support whenever required.
- Perform internal audits to ensure that Quality Standards are being adhered to.
- 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.
- 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).
- Empowered to make decisions without direct supervision.
- Comprehensive understanding of quality management systems initiatives and standards, including experience in writing policies and procedures.
- Demonstrated expertise with computerized systems validation methodologies and related industry expectations.
- Good working knowledge of industry regulations and their applicability to the work performed by Cenduit.
- Established client facing communication skills - ability to manage situations, negotiate conflicts, and influence others to achieve objectives.
- Significant experience in hosting and/or conducting audits of computerized systemswith clinical trial relevance.
- Intermediate familiarity with computerized systems validation methodologies.
- Strong problem solving/process improvement skills with ability to be part of and own solutions.
- Ability to promote quality culture throughout the Cenduit Global business
- Bachelor's Degree in scientific field or equivalent.
- 5-10 years experience working within a regulated environment with in depth familiarity with FDA and international regulations such as 21 CFR Part 11, GCP/E6, EU Directive 95/46/EC, etc. Prior regulatory inspection history strongly desired.
- 3-7 years experience in Quality Assurance role in a regulated environment or ISO 9000 certified company.
- Prior management experience
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