Quality Control Group Leader

Overview

Corium Innovations is seeking a QC Group Leader who will be responsible for daily leadership of the Quality Control laboratory group activities and personnel, including coordinating, organizing, and completing highly complex activities for the development, implementation, and maintenance of activities related to testing of raw materials, work-in-progress, finished product, and stability product.

At Corium Innovations, we’ve led the way in innovating drug delivery technologies for patients. Our purpose is to create, develop and manufacture innovative healthcare products for partners that deliver superior value to patients. Our goal is to be the best-in-class specialty CDMO through the use of innovative technologies and superior execution. Our company values are core to our culture, inspiring us to come to work every day on behalf of our people, our partners, our customers, and our patients.

• Identify improvements, provide recommendations and lead the implementation of solutions related to new and current methods, processes and procedures.
• Participate in quality audits, regulatory inspections and/or supplier audits.
• Use professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Create written procedures, methods, and instructions for laboratory activities.
• Responsible for the development and maintenance of Quality Control systems, processes, procedures and controls related to product testing GxP activities and regulations.
• Authorize to critique and sign product testing cGxP documents that require QC approval.
• Lead Quality Control technical staff engaged in QC activities through coordination of daily activities via scheduling and prioritization of workload to ensure requirements are completed properly.
• Lead Quality Control product testing staff through training, supervising, performance management, and staff development.
• Provide leadership to Quality Control individuals of various levels. Assist in hiring, managing, motivating, coaching, and mentoring analytical scientists.
• Perform employee onboarding, training, and guidance on department related procedures, activities, and processes.
• Work closely with various departments including Manufacturing, Analytical Research and Development, Process Development, Engineering Services/Metrology, Quality Assurance, Compliance, Supply Chain Management, and Project Management teams.
• Serve as a Quality Control SME and management designee for review and approval of documents.
• Lead, schedule, and execute multiple projects of high complexity with multi-disciplinary departments to ensure timely completion of project deliverables.
• Review and approve various QC-generated reports and data related to product testing.
• Communicate significant issues or developments identified during quality activities and provide recommended process improvements to management.
• Troubleshoots methods for inspection, testing, and evaluation of products and materials.

• Bachelor’s degree in a science related discipline
• 8-10 years of experience in the quality assurance, quality control, or regulatory compliance field.
• Ability to maintain accurate and detailed records.
• Proactive attention to detail; ability to complete tasks with accuracy and efficiency.
• High level of organization and ability to multi-task.
• Experience in quality reporting, trending, and data analysis.
• Comprehensive knowledge of FDA, cGMP, ICH Guidelines, Medical Device QSR, ISO, and a variety of quality concepts, practices, and procedures.
• High level of analytical, problem solving, and decision-making skills.
• Proficient computer skills including Microsoft Software Products.
• Proven computer skills and knowledge of basic statistical tools.
• Excellent communication skills including well developed oral and written communication skills.
• Excellent cross functional team skills and ability to meet large group deadlines and KPIs.
• Ability to collaborate and interact with all levels and functional areas (internally and with customers).
• Comprehensive knowledge and understanding of Method Validations, Compendial Verification, and Method Transfers.
• Proven track record with excellent performance quality reporting, trending, data analysis, investigations, and corrective/preventative actions.
• Thorough understanding and application of principles, theories, and concepts for chemical, process, and quality control applications and testing.
• Strong scientific reasoning skills.
• Demonstrated leadership and guidance experience.

• Highly competitive benefits program including medical, dental, vision, flexible spending accounts, life insurance, disability insurance, and employee assistance program.
• 401(k) retirement savings account with a company match and immediate vesting.
• 12 paid holidays.
• Competitive paid vacation plan plus ~1 additional week of paid time off for our annual holiday shutdown.