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Manager Client Engagement & Quality Assurance

Covance 6/29/2018 5:35:16 PM
JOB ID: 20859 Category: Quality Assurance
San Diego, California

   

 

Job Overview

This position can be field based or office based anywhere in the United States.
- Assure all systems, processes and their outcomes comply with standards that meet applicable international and national regulations and guidelines, and fulfill client and Covance requirements.
- Assure that all projects for which Global QA Lead responsibilities have been assigned have an audit strategy agreed and documented in the QA&C central planning system.
- Assure that audits as defined in the global audit plan are completed on time and within budget including reporting and follow up to closure.
- Provide local leadership and/or line management as required.
- This role may be an Individual Contributor or have line management responsibilities

Essential Job Duties:
- Special projects
- lead/participate in QA projects
- support special projects requiring QA input
- support QA initiatives associated with tracking, trending and analysis of audit findings
- Quality Assurance
- contribute to process improvement initiatives across organization
- provide support and direction to maintain global quality system to recognized standards
- participate in development of QA processes and SOPs
- support development of processes and SOPs by process owners outside QA *Liaison /
- Representation
- represent QA on project teams and other internal forums
- represent QA at client meetings and/or audits
- act as liaison with clients and/or their third party auditors Supervision and
- Supervision and Management
- Provide line management , if applicable
- Business Development
- contribute to the preparation of Time and Cost Estimates as requested

Education/Qualifications

Minimum Required:

Level of education required (or Experience level which may be substituted for level of education). Professional designations/certifications/licenses required
- University/college degree, BA/BS (life science preferred) or equivalent Experience
- Advanced degree (e.g. postgraduate qualification in quality assurance) or equivalent Experience

Experience

Minimum Required:

3 Years Experience in Clinical Quality Assurance, preferably with GCP Experience .

5 Years Experience in other professional roles within pharmaceutical/CRO environment.

Other required work-related Experience s:
- Proven ability to understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
- Financial understanding of global clinical development budgets
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs
- Knowledge of the drug development process from the perspective of a contract research organization

Preferred candidate with CAPA development Experience


Position Type: Full-Time

Location: San Diego, CA - California



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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 www.gettinghired.com 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).