Director, Quality and Regulatory

Your Job

Our Team

Phillips Medisize, a Molex Company is an end-to-end provider of design, development, and manufacturing solutions to the pharmaceutical, diagnostics and medical device industries. The largest pharmaceutical, MedTech and in vitro diagnostics companies in the world count on Phillips Medisize to bring their breakthrough ideas and innovative branded products to market - with confidence. As a contract design and manufacturing organization (CDMO), we work closely with our customers to deliver proven, highly engineered products that help millions of people live healthier, more productive lives including in vitro diagnostic devices, bioprocessing devices, autoinjectors, advanced, wearable injection pumps, and continuous glucose monitoring systems.

What You Will Do

• Lead the company's QA, RA, and Compliance team.
• Own and continuously improve the company's QMS in accordance with ISO 13485, FDA 21 CFR Part 820, FDA 21 CFR Part 210/211, IATF 16949, AS9100, and other applicable global regulations.
• Ensure effective document control, change management, risk management, and training systems.
• Drive continuous improvement initiatives using quality data, trend analysis, and risk-based decision making.
• Monitor regulatory changes and proactively assess impact to CDMO operations and customer programs.
• Ensure effective Quality Agreements and regulatory responsibilities are defined, executed, and maintained with customers and critical suppliers.
• Assist the Vice President of Quality and Regulatory in establishing strategic goals and objectives and deploying them successfully across the global team.
• Support external customer and notified body audits as needed within designated sites.
• Understand new and changing federal, state and local regulations that impact designated sites' regulated products and communicate changes appropriately to minimize regulatory risk.
• Work with Sales, Marketing, Program and Project Management to ensure that regulatory requirements and risk management are appropriately considered and accounted for in new programs and projects.

Who You Are (Basic Qualifications)

• B.S. degree in quality, science, business, engineering field or technical field
• Ten (10) years or more experience in a quality role.
• Experience establishing quality systems and procedures related to existing and emerging regulations.
• Knowledge of FDA and EU international regulations and ISO standards related to manufacturing (e.g. 21CFR part 820 and 210/211, EU MDR, EU MHRA, ISO 9001, ISO 13485).
• Direct experience with audits and pre-approval inspections by regulatory authorities.
• Experience in a leadership or management role

What Will Put You Ahead

• Contract Manufacturing Experience

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 the flexibility and detail of our compensation philosophy.

For this role, we anticipate paying $160,000-$190,000 per year. This role is eligible for variable pay, issued as a monetary bonus or in another form.

In order to comply with U.S. export control laws and regulations, this position requires applicants to either provide proof of U.S. citizenship or lawful permanent resident status or be eligible to receive an export authorization (a license) under the International Traffic in Arms Regulations and/or the Export Administration Regulations.

Hiring Philosophy

All Koch companies value diversity of thought, perspectives, aptitudes, experiences, and backgrounds. We are Military Ready and Second Chance employers. Learn more about our hiring philosophy here.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers' mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is a multi-sector global electronics brand owned by Koch, Inc., one of the world's largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Our Benefits

Our goal is for each employee, and their families, to live fulfilling and healthy lives. We provide essential resources and support to build and maintain physical, financial, and emotional strength - focusing on overall wellbeing so you can focus on what matters most. Our benefits plan includes - medical, dental, vision, flexible spending and health savings accounts, life insurance, ADD, disability, retirement, paid vacation/time off, educational assistance, and may also include infertility assistance, paid parental leave and adoption assistance. Specific eligibility criteria is set by the applicable Summary Plan Description, policy or guideline and benefits may vary by geographic region. If you have questions on what benefits apply to you, please speak to your recruiter.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.

Equal Opportunities

Equal Opportunity Employer, including disability and protected veteran status. Except where prohibited by state law, some offers of employment are conditioned upon successfully passing a drug test. This employer uses E-Verify. Please click here for additional information. (For Illinois E-Verify information click here, aqui, or tu).

#LI-JN2