Director of Quality Job Listing at Kelly Services in Coppell, TX (Job ID US3588345_BH9912837)

Description

Title: Director of Quality
Location: Coppell, TX
Salary: Commensurate w/ experience + Benefits 

The Director of Quality will be responsible for the development, implementation, and execution of processes that inspect and improve the quality of products.  The Director ensures that the products meet and exceed standards set by customers and any regulatory bodies for cosmetic and OTC products through the design, adherence, and enforcement of quality processes.  The position manages a team including members of Quality Control, Quality Assurance, and Microbiology.  These teams support the execution of testing, improvement, and disposition throughout the plant.  The director is responsible for development of KPIs that drive performance and evaluation based on those metrics.  The position ensures the alignment of department execution that supports the company goals and strategic initiatives while ensuring regulatory compliance. 
As head of the Quality department, the position sets the standard for quality throughout the company and drives the quality culture.  The Director develops and manages the budget for their teams and provides the framework for ensuring a robust integration of quality throughout the development, production, and supply chain processes.
 
Responsibilities and Essential Duties

• Ensure the integration of Quality in all steps of the development, manufacturing, and supply chain process.
• Train and develop the Quality Team.
• Manage the Quality team to improve and enforce quality standards through QA, QC, and Microbiology.
• Design and develop new quality control processes to improve efficiency and consistency including testing, inspection, and production.
• Interact with Regulatory bodies, such as the FDA, to ensure compliance.
• Develop, review, and approve SOPs that meet and exceed Quality standards set forth in specifications for incoming raw materials, outgoing finished goods, and work-in-process materials.
• Execute internal audits and guide third-party audits.
• Ensure a robust training framework based on cGMP, internal audits, and CAPAs.
• Support the Company's mission, values, and standards of ethics and integrity by incorporating these into the development and implementation of business plans.
• Set and maintain department goals and timelines (Key Performance Indicators).
• Drive Robust Notice of Event (NOE) investigations and CAPAs for Quality issues that arise.
• These responsibilities can and will change as we continue to grow.

Technical Skills Required

• Must possess strong technical skills. 
• Certification by ASQ, as a CQM/OE is strongly preferred. 
• Must have exceptional knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations, along with excellent decision-making skills to determine risk assessments and provide the most efficient utilization of resources to accomplish departmental objectives. 
• Excellent oral and written communication, change management, and leadership skills are required to interface with all levels of management and to coach, train, and motivate staff.
• Must possess excellent project management skills to coordinate multiple projects and adhere to tight timelines while working with people at all levels of the organization.
• Must be self-motivated and possess strong problem-solving and critical thinking skills.
• Must have excellent interpersonal and leadership skills to effectively meet objectives.
• Computer skills to include proficiency with Microsoft Office software.
• Understanding of cGMP and FDA CFR 21 Parts 210/211.
• Self-directed and motivated.
• Collaborative and team oriented.

Experience Required

• Bachelor's Degree.
• 10 or more years prior work experience in CPG or Pharmaceutical industry, contract manufacturing preferred.
• Experience in developing and managing budgets.
• Experience in managing and developing a team of at least 10 people.

Physical Requirements

• Must be able to climb stairs, stand for periods of time and have the ability to bend, squat, kneel, turn, and stoop.
• Requires some walking, as well as sitting for periods of time.
• Able to lift up to 25 pounds.
• Ability to work and function safely in a Laboratory environment.

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 for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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 participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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