Senior Quality Assurance Compliance Manager – Illinois
This position is responsible for the oversight of the site’s internal compliance and supplier quality auditing programs in accordance with US cGMPs and international regulatory requirements. This position is responsible for the oversight of the Compliance improvement recommendations and providing guidance and consultation regarding interpretation of regulatory mandates to manufacturing site. This position is responsible for the oversight of product recall activities. Responsible for oversight of the Incoming Quality Assurance (IQA) and management of Product Release department.
- Provide management oversight to the Internal Audit program and Supplier Audit program.
- Provide management of the Product release department for final product release, release protocols and certificates of analysis.
- Manage regulatory inspections and regulatory compliance activities.
- Provide management and oversight for the Incoming Quality Assurance department for raw material and plasma release.
- Oversight of all site product recall activities.
- Manage the Annual Product Quality Review program to ensure a quality report and timely completion.
- Responsible for hiring and performance management process.
- Responsible for budget and spending.
- BS/BA degree required – Technical or Scientific Degree preferred
- Excellent knowledge of FDA and European Regulatory requirements. Relevant quality auditing experience in a GMP related industry. 10 years of experience in a GMP regulated facility (biopharmaceutical preferred), with at least 5 years in a Quality Assurance supervisory position.
- Good verbal and written communication skills. Professional quality certification a plus, [i.e. ASQ Certified Quality Auditor (CQA), Certified Quality Manager (CQM)]
This global organization is one of the world’s leading pharmaceutical companies with a comprehensive line of therapies dedicated to the treatment of hemophilia, immune, wound-healing, and other coagulation disorders. They have experienced phenomenal growth over the past decade and are in the midst of a 10 year, $1B expansion, increasing capacity by 300% at the site! They offer a fantastic work culture dedicated to employee growth with a philosophy of “We know that when our employees grow individually and professionally, the company grows with them – and patients get the best care and attention they need.” Apply today!