Quality Control Manager

Woodstock Sterile Solutions•Woodstock, IL

10h•Onsite

About The Position

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We are seeking a dynamic and experienced Quality Control (QC) Manager to lead our Chemistry, Incoming Quality Assurance (IQA) and Stability functions in a fast-paced, cGMP-regulated environment. This is a high-impact leadership role responsible for ensuring compliant, efficient, and timely laboratory operations that directly support manufacturing, product release, stability and overall business performance. The ideal candidate will bring strong leadership experience within a CDMO setting, with a demonstrated ability to manage high-volume testing operations while maintaining strict adherence to regulatory and quality standards. This role requires a hands-on leader who can develop, empower and mentor teams, drive operational excellence, and foster a culture of accountability, safety, and continuous improvement. As a key member of the Quality organization, the QC Manager will play a critical role in ensuring inspection readiness and will serve as a primary representative during customer visits, customer audits and regulatory inspections. Success in this role requires the ability to balance strategic oversight with day-to-day execution, collaborate cross-functionally, and deliver consistent, high-quality on time results in a demanding production environment. The position is responsible for managing all Chemistry, IQA, Stability and method validation /transfer/development departmental activities, including staffing, training and development of staff. Manage departments to ensure products are inspected, sampled, tested and controlled within applicable requirements and quality standards in accordance with business timelines. The laboratory supports manufacturing by testing and releasing raw materials, batch and first acceptable samples, cleaning samples, finished product and stability product. The QC Manager will support New Product Introduction, New Product Development (NPD), Validation and Operations groups with testing or technical expertise. Responsible for providing key leadership, direction, organization, management, monitoring and cGMP compliance of the roles, activities and proceedings of all assigned Chemistry and Incoming Quality Assurance and other selected Quality personnel in order to ensure compliant, cost effective, timely and safe routine testing, stability testing and project support.

Requirements

BS degree in chemistry, relevant science or equivalent work experience.
Minimum 10 years of applicable experience in the industry or equivalent combination of education and experience.
Minimum 5 years of formal laboratory management (manager level or higher).
Ability to achieve and meet the expected throughput and financial goals of the organization.
Must demonstrate strategic thinking abilities.
Must be able to perform risk assessments in a timely manner and act accordingly.
Possess and demonstrate excellent verbal, written, and interpersonal communications skills.
Strong problem solving and analytical skills.
Strong ability to demonstrate ability to read, understand, interpret and apply technical writing skills and instructions.
Organized and able to multitask.
Detail-oriented.
Proven initiative and self-starter skills.
Must possess and demonstrate knowledge and experience in regulatory standards, cGMPs and relevant Safety Regulations including ISO, ICH, USP, EP and FDA.
Must be able to interact effectively with a variety of individuals within and between departments.
Excellent problem solving and analytical skills. including root cause analysis trouble-shooting experience.
Demonstrated ability to read, write, and speak clear English.

Nice To Haves

A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software, LIMs, etc.) is preferred.

Responsibilities

Support Manufacturing from a technical perspective.
Drive site improvements from a Chemistry, Stability and IQA perspective.
Serve as resident expert in chemistry testing, method development/validation/transfer, stability and Incoming QA testing requirements.
Direct quality and compliance process improvements and goals in the laboratories and Incoming QA for the site using current regulations and best-demonstrated practices.
Support effective and efficient continuous quality and cost improvement efforts in the laboratories.
Hire, develop and conduct regular performance management activities including goal setting and Performance Reviews to assure highly effective, team-oriented contributors.
Ensure all personnel receive necessary and appropriate training for their job function.
Effectively manage employee relations including hiring, discipline, rewards and recognition, and effective human capital resources allocation.
Participate in customer meetings, customer audits and regulatory inspections and inquiries.
Ensure chemistry testing and NPD project deliverables are executed successfully and on time.
Develop and achieve annual budget for laboratory operations.
Review CMC sections, technical reports, validation reports, method validation reports, specifications, procedures and SOPs.
Collaborate with other groups, activities necessary to ensure project requirements and timelines are met.
Support New Product Introduction activities.
Support and manage method transfer, method validation and method development efforts in line with customer expectations and timelines.
Identify, evaluate, and manage risk to ensure product quality.