Covance Manager Client Engagement & Quality Assurance in Dallas, Texas

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 experiences:

  • 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

Job Number 2018-20859

Job Category Quality Assurance

Position Type Full-Time

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.