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Healthtech • Biotech • Pharmaceutical
Lead GMP QA operations for outsourced biologics manufacturing and testing. Oversee CDMO and lab performance, batch review and disposition, inspection hosting and follow-up, CAPA execution, and cross-functional quality strategy to ensure regulatory compliance and supply reliability.
Top Skills:
CapaCdmo ManagementCgmpEma)GmpIchQuality Management Systems (Qms)Regulatory Inspections (Fda
Biotech
Provide QA leadership and independent oversight of QC activities for drug substance/product and release testing. Ensure cGMP compliance, data integrity, method lifecycle management, investigations, change control, CAPAs, and inspection readiness while partnering with QC and cross-functional teams.
Biotech
The Associate Director is responsible for implementing the Computer Systems and Data Integrity program, ensuring compliance with cGxP regulations and providing oversight for Computer System Validation (CSV). They manage risk assessments, cross-functional communication, and training while ensuring global compliance standards are met.
Top Skills:
SASSQL
Job Summary & Responsibilities
JD
The Director of Quality Operations is responsible for the planning, leadership and operational execution of the organization's quality departments at the site level as well as customer and supplier quality support teams. This is a highly visible and customer facing role critical to the growth and success of the company. As the quality representative on the executive staff, responsibilities include development of overall quality strategy, goals, and plans to achieve them. Oversee and coordinate quality system and quality control efforts across company facilities to which they are responsible. Drive cross-functional continuous improvement efforts to meet and exceed customer expectations. Make critical, creative and strategic decisions as a result of analysis of available information including risk-assessment for the business.
QUALIFICATIONS
- B.S. Technical, Materials Science or Quality-related discipline required or equivalent of education and experience.
- Graduate degree a plus.
- 10-15 years’ experience in quality management/engineering with demonstrable success in progressively challenging roles.
- Customer focused – prioritizes customer needs as the primary consideration in decisions
DUTIES
- Leads the company in development of overall company quality goals and objectives
- Develops long-term quality strategies, annual quality goals and metrics
- Confer with quality and operations management to develop plans to achieve goals
- Assign work to direct reports, appraise performance, reward and discipline employees, address complaints and resolve problems
- Identify department training needs and provide for appropriate training of employees
- Interface with customers on key quality issues and initiatives
- Stay abreast of current customer requirements, quality and management tools through seminars and publications
- Publish regular quality performance reports for management
- Utilize quality data to prioritize and drive cross-functional continuous improvement efforts
- Oversee and/or direct major quality system implementation projects
- Keep top management team abreast of significant issues or developments identified during quality assurance activities
- Be responsible for the application of corrective and preventive action processes in the areas to which they are responsible.
- Perform quality system documentation development and control
- Interface with internal departments, customers and suppliers as required for quality planning, quality system development and resolution of quality issues
- Provide and/or arrange quality related training for company employees
- Implement the Company’s environmental, health and safety programs in all departments/units within their respective operations
- Basic knowledge of Quality Management Systems (ISO 9001) and Environmental Management Systems (ISO 14001), as applicable
- Comply with applicable environmental, health, safety laws and regulations, Company policy, accepted safe work practices.
- Perform additional related duties as assigned.
FM Industries Fremont, California, USA Office
221 Warren Ave., Fremont, CA, United States, 94539
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