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Director of Quality

Kelly® Science & Clinical is seeking a Director of Quality for a direct-hire position at a premier, nutrition company in Portland, OR. If you are ready to take the next step in your career, trust The Experts at Hiring Experts.

Salary: $140-170K

Overview

This client is an industry-leading company focused on manufacturing the highest quality nutritional products for their clients.

The Director of Quality directs and leads a team of individuals to ensure effective quality execution, continuous improvement, and infant formula regulatory compliance. Provide leadership within the facility to drive positive change through influence and example. This individual, in conjunction with plant operations, will build and maintain an effective culture of Food Safety and quality within the facility. Is responsible for developing and maintaining facility systems and processes that ensure finished product is food safe and meets finished product specifications. This person should be a highly organized effective communicator with an inquisitive mind with the capacity to investigate and lead solution-based decision making in the plant. This role is the most responsible Quality individual as Department Head and is part of the sites Senior Leadership Team .

Responsibilities:

• Drives quality ownership at all levels, collaborating with the organization to drive the right quality culture and mindset with our employees.

• Develops quality systems, training programs, and expresses consistent, clear philosophies, and practices that align with Corporate Quality policy and ensures effective and efficient implementation across the organization.

• Subject matter expert and thought leader on all aspects of Quality Assurance including cGMP compliance, Environmental Monitoring and Hygienic Zoning, Statistical Process Control, Continuous improvement, Laboratory Operations (including instrumentation and microbiology), PX Measures, procedural document control, release and stability testing protocols, root cause problem solving and new product development- quality assurance.

• Leads USFDA inspections as most responsible quality individual and responsible for observation resolutions and close out with agency.

• Directly oversees change management program to ensures compliance with related laws, regulations, and corporate directives.

• Defines and implements facility processes in alignment with Plant Management to ensure finished product safety and quality, including ensuring all records/documentation, procedures, manufacturing operations are in compliance with company and other relevant regulatory requirements for ingredients & packaging used and products produced.

• Assists Corporate Quality and Supply Operations in the development of strategies to oversee compliance assurance at co-manufacturing sites, testing labs and warehouses

• Provides business leaders with information and analytics when making key quality decisions.

• Provides supervision for direct staff including hiring, training, performance management, mentoring and development.

• Collaborates with Corporate Quality, Manufacturing Operations, Engineering, Maintenance, Procurement, and other Supply Chain support areas to efficiently implement Quality Improvement for Right-First-time product release

Qualifications:

• BS in a Science-based curriculum (e.g., Biology, Microbiology, Food Science/Technology or Chemical Engineering) is required. Advanced degree is preferred.

• Minimum of 10 years of USFDA Regulatory inspection experience

• Minimum of 5 years of Quality leadership experience (i.e., Quality Assurance, Control, Compliance, or Improvement) within a manufacturing environment.

• Minimum of 10 years in infant formula powder manufacturing, or other relevant food industry (e.g. Specialty Dairy Ingredients [Powdered] used in Infant Formula) required .

• Advanced ability to develop and manage Quality management systems and processes

• Extensive Knowledge of USFDA regulation (e.g., 21CFR106, 107, 113, 117) and proven ability to develop applicable SOPs that are compliant to regulations and corporate guidelines.

• Food Safety Preventative Controls experience is required

• IQ, OQ, PQ and part 11 compliance understanding preferred

• Experience in gathering data from a variety of sources, analyzing, and interpreting complex problems, and utilizing effective decision-making skills to deliver superior business solutions preferred.

• Demonstrated verbal and written communication of technical information. Working knowledge of laboratory information and quality systems required

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

P#1

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

You should know:

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Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.