Associate Director, Quality Assurance

6 days ago

Singapore IQVIA Full time

**Job Overview**:
Oversee & coordinate assigned QA program in support of customer accounts, audit and inspection program, or QA quality management system at a regional and/or global level. Provide insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity/efficiency improvement initiatives. Manage the quality assurance oversight of projects, assignments, training and staff.

**Responsibilities**:

- Serve as the QA Contact for assigned internal/external customers located in Asia Pacific areas as assigned
- Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to regional and Global QA Management
- Provide Quality Assurance support, guidance and management of critical Quality Issues, as assigned
- Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies
- Serve as an author for QA Standard Operating Procedures (SOPs), and act as regional QA representative to the global QA SOP taskforce
- Host customer audits and participate in review of corrective action plans, as assigned
- Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory facility inspections, as assigned
- Plan, schedule, conduct, report and close audit activities, as assigned
- Provide Quality Assurance support, guidance and management of critical Quality Issues, as assigned
- May accompany junior auditors for training / assessment purpose, as assigned
- Oversee documentation, reporting, and closure of compliance issues
- Support Quality Management in proposal reviews and reporting QA metrics
- Conduct trend analysis of audit results, provide to internal/external stakeholders as agreed, as assigned
- Participate in or lead (cross functional) teams for special projects as assigned
- Promote the concept of quality, the principles of quality management and devise and implement quality improvements

**Requirements**:

- Bachelor's Degree
- 7 - 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GXP Quality Assurance experience.
- Strong knowledge of pharmaceutical research and development processes and regulatory environments
- Considerable knowledge of quality assurance processes and procedures
- Strong interpersonal skills and the ability to positively influence and guide others
- Excellent problem solving, risk analysis and negotiation skills
- Effective organization, communication, and team orientation and leadership skills
- Possess applicable experience in conducting audits, writing audit reports and analyzing audits
- Demonstrated ability to lead and manage multiple responsibilities
- Identify functional constraints and identify solutions
- Ability to coordinate timelines with internal customers and external vendors
- Ability to manage multiple activities and timelines
- Ability to articulate and define departmental needs and processes
- Ability to establish and maintain effective working relationships with coworkers, managers and clients

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