QA Manager

Job Overview

A career at Covance provides our employees the unique opportunity to make an immediate impact and difference in our patient’s lives. Joining Covance will offer a rewarding career, a chance to work in an energetic & team oriented work place, and access to competitive benefits. With the support of exceptional people from across the globe and a vast array of career options, you’ll be empowered to own your career journey with mentoring, training and personalized development planning. As a Covance employee, your work will be meaningful, the patient outcomes are real, and the results are lasting. Our mission is to help our clients bring the miracles of medicine to market sooner

The QA Manager (I&CAM) primary role is responsible for management of tasks related to Sponsor audits and Regulatory Inspections. The role will include if required, involvement with Sponsor audit and Regulatory Inspection finding data analysis, trending and reporting (summarizing and analyzing inspection and audit trends and signals), Quality Improvement initiatives, Quality oversight and elements of risk management.

Responsibilities:

Inspection and Client Audit Management Team (ICAM)

1. Responsible for management, hosting and follow-up of client audits and regulatory inspection activities.
2. Responsible in helping with Inspection readiness activities.
3. Responsible for coordination and management of quality improvement initiatives and projects, as assigned. Responsible for management of Inspection Readiness Plans.
4. Responsible for management of collation and reporting of quality metrics.
5. Serve as a role model, mentor and/or supervisor (when needed) for less experienced QA staff.
6. Escalate issues (as needed) to Senior QA Management.
7. Ensure that systems and processes agreed by management and implemented will ensure that Sponsor audits and Regulatory Inspections are run in a professional manner, assuring that all agreed agenda objectives are achieved.
8. Actively participate in training sessions and workshops, including presenting reports from any conferences attended.
9. Ensure timely completion and documentation of all training requirements.
10. Remain abreast of, and apply, updates to regulations, guidelines and principles related to Good Clinical Practice (GCP) and advise on their use and compliance.
11. Deputise for the Line Manager, as required. Perform any other duties, as required by the Quality Assurance department.

Education / Qualifications

• University/college degree BA/BS (Life sciences preferred) or equivalent experience. Thorough knowledge, undertanding and experience applying ICH Guidelines, GCPs including applicable regulatory requirements for the conduct of clinical development programs. Knowledge of the drug development process from the perspective of a contract research organisation.

Experience

• 5+ years experience in clinical trials, with ideally at least 2 years in a Quality Assurance auditor or similar role.