Quality Manager

Koch•Hudson, WI

17d•Onsite

About The Position

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. 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.

Requirements

Bachelor’s degree or higher in a scientific discipline
10+ years of experience in Quality Assurance within the pharmaceutical, medical device, or biotechnology industry
10+ years of direct experience in drug product manufacturing
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

Nice To Haves

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

Responsibilities

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