Corium Innovations · 1 day ago
Quality Control Group Leader
Grand Rapids, MI
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expCorium Innovations is seeking a QC Group Leader who will be responsible for daily leadership of the Quality Control laboratory group activities and personnel. This role involves coordinating and completing complex activities related to testing raw materials, work-in-progress, finished products, and stability products.
Health CareMedicalPharmaceutical
Responsibilities
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
Uses 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
Authorized to critique and sign product testing cGxP documents that require QC approval
Leads and directs 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
Performs employee on-boarding, 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
Serves 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
Reviews and approves various QC generated reports and data related to product testing
Communicates significant issues or developments identified during quality activities and provides recommended process improvements to management
Troubleshoots methods for inspection, testing, and evaluation of products and materials
Qualification
Required
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
Benefits
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.
Company
Corium Innovations
Corium Innovations developes and produces novel drug delivery technologies.
51-200 employees
H1B Sponsorship
Corium Innovations has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Growth StageTotal Funding
$100MKey Investors
Webster Equity Partners
2022-10-20Private Equity· $100M
2018-11-27Acquired
Leadership Team
Mark Sirgo
Chief Executive Officer
Ellen Shaffer, SPHR
Associate Director, HR Business Partner
Recent News
BioWorld Financial Watch
2025-07-29
2025-04-02
2025-04-02
Company data provided by crunchbase