Associate Director of Quality Assurance, Singapore

Job description :
Job Duties and Responsibilities: Auditing * participate in audits, as assigned, according to applicable SOP(s) and the project Quality Plan * provide guidance to QA&C project auditors regarding GCP issues relating to the project Quality Plan * identify non-conformances with requirements and provide suitable recommendations * assure that audit reports are completed in a timely manner and that audit results are communicated to auditees and management * ensure suitable responses and action plans provided by auditees * escalate to management where resolution of audit findings are inadequate * prepare overviews of audit findings for presentation to management * serve as a backup auditor to other QA&C staff Special Projects * lead/participate in QA projects * support special projects requiring QA input * tracking, trending and analysis of audit findings to drive process improvements Quality Assurance * contribute to process improvement initiatives across organization * develop and maintain global quality system to recognized standards * direct and/or 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, management meetings, 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 Management * Provide regional leadership and line management * provide local/global supervision of assigned department/function * assist in providing staff training, mentoring, coaching, performance feedback career development and performance standards Business Development * participate in negotiations with clients * contribute to the preparation of Time and Cost Estimates

Qualifications :
Education / Qualifications Required * University/college degree, BA/BS (life science preferred) or equivalent experience * 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 Preferred * Masters or other advanced degree (e.g. postgraduate qualification in Quality Assurance) or equivalent experience * Knowledge of the drug development process from the perspective of a contract research organization

Experience :
Experience / Skills Required * Minimum of seven (7) years experience in the pharmaceutical/CRO industries, with at least four (4) years in Clinical Quality Assurance, preferably within a GCP environment * Strong analytical skills * 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

Job information :
This job offer is open to foreigners and expatriates applicants.

Job location :
Singapore

Contract type :
Full Time

If you are interested to apply for this job offer, please register or login to your personal space.