Career Opportunities

Associate Director, Quality Assurance

Description of Duties:

• Responsible for daily Quality Assurance support of clinical manufacturing operations to include: production, testing, batch record review, investigations, product and raw material disposition, change control environmental controls and plant utilities.
• Direct supervision and development of Plant QA staff. Accountable for supervisory and staff development responsibility through proper staffing, training, and quality-related goals that significantly contribute to the success of the entire organization.
• Consults with Operational leadership to identify key areas of focus and develops a QA plan that includes internal auditing, reporting, situational analysis, strategizing and developing programs and process refinement through quality improvement.
• Conducts program and quality benchmarking and research to support initiatives.
• Demonstrates and promotes the company vision.
• Maintains knowledge of current Good Manufacturing Practices (cGMP) relating to clinical supply management, packaging, distribution, investigations, change control, CAPA, etc.
• Supports all regulatory compliance issues related to FDA, EMA and all other state, federal, and international regulatory agencies.
• Coordinates review, generation, revision and approval of all Standard Operating Procedures and ensures training compliance of the same.
• Interacts regularly with Quality Assurance staff to identify trends in non-conformance issues, customer complaints and deviations; communicates trending information to Leadership Team, and collaboratively develops preventive action plans.
• Other duties as assigned.

General Duties:

• Ownership of the Sangart Management Review process and analysis/reporting of all Quality Assurance metrics.
• May lead or participate in vendor audits and certification programs.
• Conducts internal Quality System Audits.
• Monitor and proactively manage quality performance using advance tools and statistics.
• Review/approve complex quality system data/documentation.
• Using trending analysis tools recognize complex quality system deficiencies and lead improvement projects.
• Evaluate product, materials and components for disposition.
• Independently investigate and resolve complex quality system issues.
• Conduct internal and external Quality System audits.
• Manage Qualified Person and other internal inspections.

Minimum Job Qualifications:

• Bachelor's degree in biology or related life science field plus 10 years regulated industry experience.
• Minimum of 6 years' experience in a GMP manufacturing environment.
• Exceptional investigation, root cause analysis and problem solving skills.
• Working knowledge of operational improvement ideology and Statistical Process Control methodologies.
• Exceptional organizational, time management and communication skills.
• Demonstrated ability to negotiate through controversial issues with a balanced and diplomatic approach.
• Ability to handle multiple projects simultaneously.
• Proficient with standard office software programs.