Director, Project QA Compliance

Director, Project QA Compliance

Location: Lake Forest, Illinois Type: Direct Hire Full Time permanent direct with client Compensation: $150,000 - $190,000 Work Model: Hybrid – onsite Tues and Thursday Hours: 40.0 This is an opportunity to join a growing biotech company where Quality has strong visibility and influence across the organization. The role offers broad exposure across commercial and clinical manufacturing, CMO oversight, and quality strategy in a collaborative, hands-on environment.

Responsibilities

• Support GMP quality program and implement quality programs for all commercial and clinical manufacturing operations to achieve corporate compliance goals.
• Manage GMP compliance for all relevant local requirements for products developed.
• Implement and communicate the quality strategy, policies, and programs throughout the organization.
• Promote recognition of quality programs among internal and external customers.
• Direct QA activities and oversight of multiple functional areas and Contract manufacturing sites, ensuring consistent application of cGMPs; QSR; ICH Q8, Q9, and Q10, and other relevant regulations and guidance to assure quality of products.
• Support activities for manufacturing and materials management departments including review of draft and executed batch records, product release, QA review and approval of labeling artwork, and issuance of labels, as well as authoring and maintaining Quality Agreements, Annual Product Reviews (APRs), and supporting internal and external audit activities.
• Oversee all contact with the FDA and marketing partners regarding quality issues including field alerts, recalls, or regulatory actions.
• Manage GMP inspections and audits from regulatory authorities and marketing partners and provide follow-up responses for all aspects of the business.
• Organize internal investigations and ensure complete and accurate documentation.
• Review and approve documents as required, including protocols, reports, and document changes.
• Collaborate with internal and external clients and regulatory agencies to resolve quality issues and maintain GMP compliance.
• Promote a positive work environment by communicating clear direction on corporate goals.
• Manage and support GMP Quality Management Systems.
• Responsible for batch review and batch disposition.
• Oversee product complaints for commercial and clinical trial materials.
• Establish quality metrics for functional areas within the organization.
• Conduct investigations into GMP-related issues and manage the QA change control process.
• Support activities including review of batch records, release of pharmaceutical products, and QA review of product label proofs and issuance of labels.

Requirements

• At least 10 years of experience in commercial GMP operations, with at least 5 years' experience in GMP Quality including Product Lead and CMO oversight.
• Experience with effectively managing Contract Manufacturing Organizations.
• Solid understanding of quality management and continuous process improvement principles, including global cGMP requirements, ICH Q8, Q9, and Q10, and other relevant regulations and guidance.
• Good written and oral communication skills.
• Experience with stability monitoring of injectable drugs and oral solid dose.
• Experience with PAI preparation and readiness planning (preferred).
• Demonstrated ability to work in a multi-disciplinary setting, acting as a facilitator to drive fulfillment of corporate strategic goals.
• Background in Continuous Improvement and implementation of Quality Metrics.
• Educational background: B.S. or B.A. in Natural Sciences or Science; advanced degree strongly preferred.
• Certification/training in applicable quality management disciplines.

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #568-Clinical