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Director Quality Risk Management Oversight

Covance 6/26/2018 5:43:21 PM
JOB ID: 20804 Category: Other
San Diego, California



Job Overview

Director, Quality Risk Management Oversight

A career at Covance provides our employees the unrivaled chance to create an immediate impact and difference in our patient's lives. Joining Covance will offer a rewarding career, a chance to work in a high-energy & 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 -- join us for your next career move.

Essential Position Duties:

* Ensure the CPS and CDS organization understands ICH / GCP guidance as well as local regulatory requirements as it relates to risk management
* Develop and maintain collaborative working relationships between Clinical Quality Assurance, CRUs and Phase I-IV businesses, across all functions within the operational organization
* Standardize CRU approaches to risk management to promote workable solutions to proactively pre-identify identify risk and ensure working standards are appropriately implemented, and if necessary, modified to manage risk
* Ensure organizational consistency of delivery against Covance related Risk Management Controlled Documents
* Ownership for the development and maintenance of the annual Quality Risk Management (QRM) Oversight Plan
* Ensure alignment of QRM across staff, processes and technology across business units and functional groups (e.g. CRUs, PM CoE, Central Monitoring, Xcellerate® Suite, etc.)
* Establish an ongoing process to evaluate the QRM processes in support of Covance's continuous improvement efforts; communicate results to management and functional leaders as appropriate
* Partner with the Regulatory Intelligence organization to ensure that Covance Controlled Documents are compliant to health authority regulations for risk management pertaining to the conduct of clinical trials
* Implement standard communication and education across all global regions to obtain and maintain desired state. Evaluate effectiveness on an ongoing basis
* Support business development activities through provision of input into the sales strategy and delivery
* Establish and maintain relationships within and/or outside the organization to broaden business knowledge and trends



* Bachelor's Degree required from an accredited institution required
* Master's degree and/or equivalent Experience & Six Sigma Black Belt Certification preferred


Experience :

* Minimum of 10 years of Experience Clinical Operations area in a pharmaceutical company/CRO
* Project Management, Quality Management and Six Sigma Experience is highly desirable
* Experience with clinical research units and healthcare setting is preferred
* Experience in and/or knowledge of risk management in a regulated industry is required
* Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
* Consistent track record for transformational projects which have demonstrated improvement to business gaps
* Demonstrated consulting skills, with change management concepts and strategies, including communication, culture change and performance measurement system design
* Recognized subject matter authority that will help influence the way things are done
* Strong analytical and decision-making skills
* Basic knowledge of sales and business development strategies and procedures
* Excellent interpersonal skills (oral and written) with the ability to communicate across multiple functions and levels

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Position Type: Full-Time

Location: San Diego, CA - California


Covance Recruiting Process

Below is a general Overview of Our Recruiting Process

If you’d like to work for us, please submit your resume/CV online. If your ability to use or access our electronic application is limited due to a disability, please visit or call 1-800-978-4473 for help.

We consider applications from everyone who is interested in a position with us and who meets the required criteria and qualifications.

If your application is selected, someone from our recruiting team will contact you to arrange an initial screen. We may carry this out over the phone or at a face-to-face meeting. You must complete the screen to be considered for the position.

Based on the results of the initial screen, we may invite you to an interview. One of our recruiting team members will contact you to arrange this. The process may involve several interviews, initially over the phone, and then face-to-face with different members of the hiring team.

Our interviews follow a behavioral-based format. This means we’ll ask you to give us information that’s specific to your professional and educational experiences.

Hiring team members will share and discuss their input and then make their decision.

If you’re the person who best meets the requirements of the position, a member of the hiring team will get in touch to make you an offer of employment. Covance is an eVerify employer (United States only).