Quality Manager

Your Job

Phillips Medisize, a Molex Company, is seeking a contribution-motivated Quality Manager to join our St.

Croix Meadows manufacturing facility in Hudson, WI.

You will create value by stewarding New Product Introductions (NPI) with your background in pharmaceutical quality assurance, a passion for ensuring the highest standards in product quality and compliance, and a commitment to excellence.

Our Team

Phillips Medisize is an end-to-end provider of innovation, development, and manufacturing solutions to the pharmaceutical, diagnostics, and medical device industries.

We work collaboratively within our Global Quality Organization to deliver compliant and effective solutions to our customers.

What You Will Do


* Ensure compliance with regulatory requirements and internal procedures including notified body and regulatory inspection support


* Ensure effective stewardship of NPI programs and their successful progression to commercial production


* Provide coaching and development to your team of leaders, and ensure your entire organization is leveraging its individual and collective comparative advantage


* Develop and monitor Quality KPIs to drive continuous improvement within the quality system


* Ensure functional group collaboration on NPI program and other project support efforts


* Ensure proper establishment of requirements and ongoing compliance for drug handling and associated laboratory operations


* Actively contribute to a safe and inclusive workplace environment

Who You Are (Basic Qualifications)


* Bachelor's degree or higher in a scientific discipline


* 7+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry


* 5+ years of direct experience in a drug product manufacturing environment


* Highly competent working knowledge of ICH and relevant CFRs and other industry guidelines


* Proficiency in quality management tools, methodologies (e.g., risk assessment, root cause analysis, FMEA), and software systems

What Will Put You Ahead


* Proven experience in GxP audits, quality management systems, and CAPAs


* Strong analytical skills for data analysis and trend identification


* Competency in statistical tools and process validation


* Effective cross-functional collaborator with teams such as Regulatory Affairs and CMC (Chemistry, Manufacturing, and Controls)


* Supervisory experience

This position does not qualify for VISA Sponsorship.

At Koch companies, we are entrepreneurs.

This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions.

Any compensation range provided for a role is an estimate determined by available market data.

The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location.

If you have questions, please speak to your recruiter about t...