Quality Control Manager

Kelly Science has an immediate opening for a Quality Control Manager for our growing client near Minneapolis, MN.

Full-time

Direct Hire

Salary: $110,000-$135,000 DOE

We are seeking an experienced Quality Control Manager to lead our QC team in driving quality excellence, process optimization, and regulatory compliance across our laboratory operations. This role is pivotal in ensuring our products meet stringent quality standards, regulatory requirements, and align with our company's vision and growth objectives. You'll manage end-to-end QC functions, including lab oversight, program development, and process improvement, fostering an environment of continuous learning and innovation.

Key Responsibilities:

• Lead and Mentor: Build, develop, and inspire a dynamic team of Quality Control professionals by providing strategic direction, technical guidance, and career development support to foster a culture of quality and continuous improvement.
• Quality Programs and Oversight: Manage and enhance QC programs, including the stability program, to maximize efficiency and effectiveness while staying within budget and regulatory compliance with FDA, ISO, and GMP standards.
• Laboratory Operations: Ensure calibration, maintenance, and regulatory compliance of all laboratory equipment, and validate analytical methods before deployment. Lead cross-functional laboratory functions including Microbiology, Analytical, and Quality Control.
• Issue Resolution: Review and approve OOS investigations with thorough root cause analysis, taking immediate corrective action and escalating issues to senior management as necessary.
• Collaboration and Cross-Functional Integration: Partner with departments like Planning, Supply Chain, R&D, QA, Manufacturing, and Operations to drive cross-departmental alignment and proactive quality enhancements.
• Customer and Supplier Interface: Act as the point of contact for customer and supplier quality-related inquiries, identifying improvement areas and ensuring high satisfaction through effective communication and quality assurance practices.
• Performance Management: Set clear performance expectations, conduct regular reviews, and develop improvement plans for the team to maintain and exceed quality KPIs.
• Continuous Improvement: Identify and lead opportunities to enhance QC processes, streamline workflows, and ensure adherence to Quality KPIs, addressing any deviations promptly.

Required Skills and Abilities:

• Demonstrated leadership with a proven track record in managing, motivating, and developing high-performing QC teams.
• Strong communication skills (written, verbal, interpersonal), with the ability to prioritize multiple responsibilities and manage deadlines effectively.
• High level of organization, attention to detail, and confidentiality.
• In-depth knowledge of regulatory guidelines (GMP, ISO, Data Integrity, Safety).
• Proficiency in Microsoft Office Suite and laboratory software applications.
• Problem-solving and analytical abilities, with a proactive approach to quality and process improvements.

Required Education and Experience:

• Bachelor’s degree in Chemistry (or related field) with 5-10 years of management experience in a Quality Control lab environment, particularly within the pharmaceutical industry.
• Minimum of 5 years of analytical chemistry experience.

Preferred Education and Experience:

• Advanced degree (PhD or Master’s) in Chemistry.
• 7+ years of analytical chemistry experience in the pharmaceutical industry.

Why Join Us?

We offer a collaborative work environment that values integrity, quality, and innovation. This is an opportunity to take ownership of a key function within a dynamic organization committed to excellence and professional growth.

Ready to lead quality to new heights? Apply now and make a meaningful impact on our team and industry!