Associate Director - Quality Assurance
Provide overall leadership for the functions and responsibilities to establish comprehensive quality processes and systems. Manage the quality assurance oversight of Symbiance projects, assignments, training, and staff.
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.
Oversee & coordinate assigned QA activities in support of customers, functionals, audit and inspection programs, or QA quality management system at a global level.
- Provide guidance, interpretation, support, training, and key input s consultation and interpretation of regulations, guidelines, corporate standards, and policies.
- Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.
- Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to projects.
- Plan, conduct, report, and follow-up of internal audits, in accordance with current SOP(s) and participate in the review of corrective action plans, as assigned
- Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory inspections, as assigned
- Support Inspection Readiness Activities
- 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
- Provide suggestions for continuous quality improvement in GCP.
- Review relevant project documentation for compliance with GCP and corporate standards
Skills & Qualifications
- Full time - Bachelor's Degree Preferably
- 10 year's experience Quality Assurance experience in pharmaceutical, technical, or related area including GCP Quality Assurance auditing experience. Equivalent combination of education, training, and experience.
- Experience in working for ISO QMS and ISMS audits is a must.
- Strong knowledge of pharmaceutical and CRO processes and regulatory environments.
- Possess applicable experience in conducting audits, writing audit reports and analyzing audits.