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
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
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