Associate Director, Quality Assurance
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.
The Associate Director will support the Quality Assurance organization with line management responsibilities and continuous improvement of procedures and processes. Support and maintain all aspects of the Quality System in accordance with the company's quality manual, standard operational procedures and customer requirements. Organize, perform and support regular audits at assigned locations. In a direct supporting role to the Vice President, this role will also be responsible for occasional liaising with senior Cenduit Management and client management to support key engagements and escalations, representing Cenduit and/or Cenduit QA at key meetings, etc.
- Aligns responsible QA resources towards specific functional efforts to improve operational effectiveness and consistency, efficiency, and quality of delivery. Able to combine strategy with conventional and unconventional thinking to form innovative, yet compliant solutions.
- Examines current landscape to determine where new or updated processes may provide value added benefit, risk reduction, and efficiencies.
- Serves 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.
- Manages sponsor audit support globally. Assigns, hosts, and supports sponsor audits across all sites, ensuring that staff are prepared for and responsive to the audit throughout the process, including post-audit follow-up activities (e.g., prompt responses to audit reports).
- Shares 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.
- Proactively monitors compliance with Quality System reviews, Corrective And Preventive Actions, training, internal auditing, and supplier management.
- Conducts 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.
- Performs 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.
- Keeps up to date with all related quality legislation and compliance issues.
- Represents the company during external inspections as required.
- Responsible for the vendor (supplier) audit program globally and performs vendor evaluation / vendor audits as required.
- Liaise with customers and suppliers where necessary (where impacting/affected by quality issues).
- Expected and empowered to make decisions without direct supervision.
- Established senior management facing/client facing communication skills - ability to manage situations, negotiate conflicts, and influence others to achieve objectives and resolve concerns in both written and oral presentation formats.
- Strong problem solving/process improvement skills with ability to be part of and own solutions.
- Drive to seek solutions with intent and priority through a balance of creativity and restraint.
- 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.
- Significant experience in hosting and/or conducting audits of computerized systems with clinical trial relevance. Intermediate familiarity with computerized systems validation methodologies.
Education and Experience:
- Bachelor's Degree in scientific field or equivalent.
- 7-10 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 audit hosting and/or regulatory inspection history strongly desired.
- 7+ years' experience specifically within a Quality Assurance role in a regulated environment or ISO 9000 certified company.
- 3-5 years' experience in a functional and line management experience.
International travel required 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.
Meet Some of Cenduit's Employees
Adam is a liaison between the client, comprised of sponsors and pharmaceutical companies, and Cenduit’s Technical Team—the people who develop the software for clients.
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