Associate Director, Quality Assurance

Job Overview

Assure all systems, processes and their outcomes comply with standards that meet applicableinternational 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 anaudit strategy agreed and documented in the QA&C central planning system.

Manage allocation of QA&C staff within local region to complete the required audits andfulfill staff utilization / achievement of QA&C targets

Assure that audits as defined in the global audit plan are completed on time and within budgetincluding reporting and follow up to closure.

Provide local / regional leadership and line management as required

Education / Qualifications

Minimum Required :

University / college degree, BA / BS (life science preferred) or equivalent experiencePreferred

Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or equivalent experience

CompetenciesRequired :

Excellent technical knowledge, understanding and experience in applying ICH / FDA / Good Clinical Practices

Excellent oral, written and presentation skills

Excellent planning and organizational skills

Proven interpersonal skills

Demonstrated ability to handle multiple competing priorities across clinical operating units

Ability to inspire effective teamwork and motivate staff within a matrix system

Ability to function as a member of a global clinical team

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

Minimum Required :

4 years’ experience in Clinical Quality Assurance, preferably with GCP experience

7 years’ experience in other professional roles within pharmaceutical / CRO environment..Other required work-related experiences

Thorough knowledge of ICH Guidelines and GCP including international regulatoryrequirements for the conduct of clinical development programs

Knowledge of the drug development process from the perspective of a contract researchorganization

Job Number 2018-18699

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).

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