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Form of workAt MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Position Summary:
The Manager, Quality Assurance will oversee Quality Control activities, Systems, and Compliance. Review and approve all quality control related documents like analytical records, method validation protocols & reports, specifications, methods, stability protocols & reports, etc. Ensure compliance to cGMP/GLP in the laboratory on day-to-day basis. Implement and oversee robust Stability Program, Quality Risk Management, Clinical Operations, and Computer System Validation processes.
Principal Responsibilities:
Working with QC, Manufacturing, Research and Development, Device development, and Regulatory Affairs to provide professional quality guidance to assess, correct, and maintain the product and process quality using statistical tools, documented methods, experimental designs and sampling plans.
- Manage Deviations, Investigations, FAR, Recall and CAPA program
- Manages Stability Program for Commercial and R &D projects.
- Responsible for Annual Product Review process including reporting
- Manages Quality Risk Management and Computer System Validation program
- Provide technical advice to the site leadership team on quality, reliability, safety and performance issues encountered during product life cycle.
- Provide technical support to project teams. Interface with functional areas in such areas as preparing test plans, data analysis, specifications, risk analysis, change implementation and process validation. Provide technical advice on component and system failures that occur in manufacturing and the field.
- Author technical protocols, reports and management reports
- Ensures compliances with Regulatory and Compendial standards as applicable.
- Liaisons with Quality Control and Analytical Development teams on cGMP compliance
- Manages FDA and other regulatory inspections
- Comprehend and interpret regulatory and quality standards. Identify, communicate and escalate complex technical issues and compliance issues. Identify options for resolution and lead implementation of correction actions
- Identify and benchmark compliance best practices, implement improvements to reflect best practices
- Provide guidance/leadership to QE specialists, prioritize work assignments to meet schedules
- Provide guidance in technical transfer, concurrent engineering and Quality by Design
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
Required Skills and Experience:
- BS degree in a scientific or technical discipline with 10-12 years of experience or an MS Degree with 6-8 years of experience or an equivalent combination of experience and training.
- Experience in the bio/pharmaceutical or device industry in manufacturing operations with device development/manufacturing or pharmaceutical process experience preferred.
- Required knowledge of GMP compliance and ISO standards
- Certified Quality Engineer
- Six Sigma Black Belt
- Strong Oral and written communication skills including experience in Word, Excel, and other statistical programs
- Strong interpersonal skills and organizational abilities
