Director - Quality Assurance Job Listing at Kelly Services in Solon, OH (Job ID US3551133_BH9783060)

Description

Kelly Science & Clinical is seeking a Director - Quality Assurance southeast of Cleveland, OH.

Direct Hire

Relocation assistance provided

We are seeking a Quality Assurance professional with experience and responsible for establishing and maintaining cGMP procedures and Quality Management Systems. The individual will lead the effort in providing oversight of all Quality Assurance activities. The position will also have technical and support responsibilities to win and manage commercial customers.

 

Duties include:

• All day to day Quality Assurance responsibilities.
• Providing Quality oversight and approval for a wide variety of internal laboratory activities that include stability studies, formulation development and characterization, process development, manufacturing of prototype formulations, and developing and executing analytical chemistry test methods.
• Responsible for the Quality Management System; including drafting, routing for approvals, distributing current revisions of Quality documents, initiating and documenting training, providing strategic direction to the company to continuously improve Quality.
• Manufacturing site identification, inspection, and qualification of CDMOs for company's programs that require contract development and manufacturing and providing Quality oversight during production through release of company's pharmaceutical products.
• In partnership with QC Operations, lead the identification and implementation of strategic facility and equipment initiatives, QMS continuous improvements, and oversight of third-party standards (FDA, GMP, ICH, ISO, etc.) to ensure continuous improvement and that customer needs are met.
• Lead efforts to identify, inspect, and qualify all appropriate cGMP vendors on an ongoing basis that includes CMOs, excipient and chemical suppliers, contract labs, and other organizations, as required.
• Manage storage of quality system records (paper and electronic) including SOPs, technical reports, training records, log books, and others as necessary.
• Provide Quality Assurance and program updates for customers, project teams, and other groups as needed.
• Provide technical input to Business Development for proposal preparation and Lead management
• Other duties as assigned

 

Requirements:

• A BS or MS in chemistry, pharmaceutics, chemical engineering, or other closely related fields.
• 15 years or more of pharmaceutical industry experience with an emphasis on Quality Assurance.
• A thorough understanding of the Quality Assurance function in the pharmaceutical and biotech industries.
• A thorough understanding of FDA, ICH and cGMPs requirements for pharmaceutical formulation, analysis, stability and manufacturing of drug products.
• Excellent verbal and written communication skills
• Self-motivated individual with self-starting capabilities
• Motivated to learn new skills and applying them to success and growth of company
• Must be a US citizen

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.

 Apply on company website