Director of Quality Management- Dallas, TX

The Director of Quality Management is responsible for the overall performance of the quality assurance and quality control systems of the Company in adherence with regulatory standards.

Job Responsibilities:

• Responsible for the continuous improvement and management of the integrated Quality Systems of the Company.

• Maintain the Quality Management System by overseeing key processes and activities such as the inspection process, nonconforming materials process, internal and external audits, Corrective and Preventative Action investigations, and change control for documents, processes, and products.

• Promote the development of a company-wide culture of quality excellence and understanding of the key elements related to the quality systems.

• Ensure that Company facilities are in compliance with all dietary supplements, cosmetics, food and drug regulations that pertain to the operation.

• Analyze appropriate procedures and corresponding practices and recommend and direct strategies for regulatory compliance.

• Conduct internal audits of facility for quality control practices and ensure that the practices are compliant to documented process and applicable regulations.

• Audit external partnerships for quality control practices and process compliance to documented process of record and applicable regulations.

• Ensure action plans are implemented and maintained through follow-up inspections, internal audits, and checks.

• Coordinate ISO conformance audits of Quality Management System, by serving as the ISO Management Representative.

• Approve Company SOPs for the Quality Management Departments.

• Comply with Company SOPs and policies.

• Maintain knowledge of existing regulations, standards, or guidance documents.

• Work under applicable regulatory guidelines.

• Assist with technical matters.

• Coordinate GMP & food conformance audits, by serving as the GMP/FSMA management representative.

Education/Experience Required

• Bachelor’s degree scientific or technical field from an accredited college required.

• Graduate degree preferred.

• Minimum 5 years' experience in GMP-regulated industry with experience conducting GMP internal audits.

• Minimum 5 years' experience in managing Quality Management systems activities such as document and change control, quality systems auditing, supplier management, raw material or finished product inspections, and nonconforming or out of specification review processes.

• Minimum 2 years of work experience with ISO 9001 Quality Systems

• Previous experience in pharmaceutical manufacturing environment preferred.

• Previous experience with cosmetics, pharmaceutical/nutraceutical, food products and/or dietary supplements.

• Knowledge of quality control lab environment preferred.

• Must have experience of ALCFR part 111

• Proficient knowledge of FSMA, and the proven ability to write FSMA plans.

Job Details:

• Competitive Salary

• 401K matching, Dental Insurance, Employee Assistance Program, Flexible Spending Account, Health Insurance, Health Savings Account, Life Insurance, Paid Time Off, Parental Leave, Tuition Reimbursement, Vision Insurance

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.

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 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.

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.