job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: North Chicago, Illinois
job type: Contract
salary: $65.00 - 69.15 per hour
work hours: 9 to 5
- Direct responsibility for Quality System Integration for Quality Risk Management, including Company's process and procedure documents.
- Design, develop and deliver a comprehensive risk management integration program across the company. Chair and charter governance programs in relation to managing the quality systems related to risk management.
- Assure integration of applicable product regulations.
- Develop, maintain and improve QA procedures for risk management that support Company's business objectives, functional area strategies, and the overall quality system.
- Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates. Oversee the implementation and management of training programs for QRM integration.
- Interact with Company Executives as well as with RnD, manufacturing science and technology, supply chain, program management and Regulatory Affairs management.
- 6 to 8 years' experience
- Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
- Minimum of 10 years' experience with quality assurance and/or quality system oversight. Risk Management and Device regulation experience preferred.
- High level of competence, confidence, and credibility for interaction with executive management.
- Leadership of other technical professionals and experience in leading cross-functional teams with results-orientation.
- Skilled in the strategy development, initiation, selection, coordination and management of projects and have the ability to solve unique problems.
- Knowledge of regulations and standards affecting devices, biologics and pharma products. Knowledge of ICH standards, ISO standards, US Code of Federal regulations, and the EU regulations.
- Conflict resolution skills including persuasive management techniques required.
- Strong oral and written communication skills needed.
- Excellent interpersonal skills a plus.
skills: Project Management, Quality Assurance, MS-WORD, MS-EXCEL, MS-Project, ICH Regulations
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.