Quality Assurance, Senior Manager / Associate Director
Oversees the development, implementation and maintenance of QA systems and activities.
Manages SillaJen’s Quality Audit Program (CMO/CRO/Vendor Qualification Audits). Conducts internal and external GxP audits. Supports senior management in promotion and assessment of policies and procedures to ensure Quality standards in compliance to regulations, guidelines and corporate policies.
Essential Duties and Responsibilities
- Oversee, conduct or manage audits per the GxP Audit Program in support of clinical and nonclinical studies and contract manufacturing facilities.
- Evaluate audit/inspection findings and prepare and distribute reports to operations staff, management, and other stakeholders.
- Act as the primary contact with vendors, contract facilities and joint development collaborators for audit closure, Quality agreements, change management contracts (as needed) and other QA needs.
- Provide interpretation on current GxP regulations, guidelines, policies and procedures to internal staff.
- Assist in developing, establishing and maintaining QA programs, policies and procedures to ensure adequate GxP compliance.
- Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
- Represent QA in multifunctional projects related to continuous improvement or processes and systems.
- Report to Senior Director of Quality periodically on progress and needs within the QA organization.
- Participate or lead FDA inspections.
- Train and update Quality Assurance staff as required
- Domestic and international travel will be required between 20-30% of the time.
Education and Experience
- BS/BA degree in a science related discipline and minimum of 10+ years of related Quality Assurance experience or
- MS/MA degree in a science related discipline and minimum of 8+ years of related Quality Assurance experience of
- PhD in related discipline and minimum of 6+ years of related Quality Assurance experience
- Possess strong working knowledge of GLP/GMP/GCP - FDA regulations and ICH Guidelines.
- Experience in Quality assurance overseeing Viral or Cellular based production and/or related activities.
- Ability to work efficiently in a dynamic fact paced environment and to prioritize multiple projects and activities.
- Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
- Ensures budgets and schedules meet corporate requirements.
- Ability to think strategically and maintain attention to detail.
- Collaborative and able to interact with all levels of the organization including coordination among groups/departments.
- Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
- Excellent written and verbal communication skills including strong negotiation and decision-making ability.
- Knowledge of Microsoft Office applications including Excel, Word, Power Point, and Microsoft Project.
- Auditor certifications are preferred
- Experience with Pharmacovigilance auditing a plus
- Experience with establishing validated documentation systems and a strong understanding of 21CFRpart11 and computerized validation a plus