Kelly Scientific is supporting a generic pharmaceutical manufacturer in central Illinois who are seeking a dynamic Head of Site Quality to drive compliance, patient safety and continuous improvements.

　　Title : Head of Site Quality

　　Location : Decatur, Illinois

　　Salary : $175-190,000 + Benefits

　　Position Summary:

　　This position reports to the VP of RAQA and key responsibilities include, building and leading an effective quality unit, effective management of quality systems and implementing a quality culture. You will directly manage key quality functions, such as Quality Assurance, Quality Control, Sterility Assurance and Microbiology. The Head of Site Quality will prepare the Decatur sites towards all time FDA readiness and function as the key point of contact during FDA inspections and interactions.

　　Essential Duties & Responsibilities:

　　Preparing Decatur sites for FDA readiness, managing FDA inspections, internal audits/external audits

　　Build and manage effective quality Unit, comprising of various QA functions, Microbiology and QC Laboratory

　　Promote a positive quality culture, with effective oversight over critical quality systems and operations resulting in high quality sterile pharmaceutical products.

　　Leading and directing the Aseptic Processing/Sterility Assurance team, providing hands-on guidance and support to ensure the team is successful in meeting their objectives.

　　Implement and oversee data integrity controls in manufacturing and laboratory function. This includes effective quality review of critical data integrity controls, critical material attributes, process parameters and critical quality attributes to ensure products comply with FDA regulations and deliver sustainable quality to meet patient needs.

　　Implement a robust Sterility Assurance and Contamination Control Strategy

　　Developing and implementing learning and development opportunities for team members to enhance their skills and abilities

　　Establishes and reviews Quality Metrics to track/trend key parameters for quality compliance, quality operations and continuous improvement

　　Works with site head, corporate and senior stakeholders to develop quality budgets and strategy to support sustainable growth.

　　Collaborate with FDA as the need arises representing the firm to authorities and regulatory inspectorates in matters relating to GMP

　　Developing and implementing learning and development opportunities for team members to enhance their skills and abilities

　　Lead the site in regulatory inspections and customer audits

　　Developing and implementing learning and development opportunities for team members to enhance their skills and abilities

　　Oversee implementation of effective and timely CAPA’s and Changes

　　Ensure compliance with all pre and post approval commitments

　　Position Requirements:

　　Advanced scientific degree (Master of Science, PharmD, PhD) preferred, or Bachelor’s degree with relevant experience

　　At least 15 years of Quality experience in Sterile Pharmaceutical or Biopharmaceutical space.

　　At least 5 years of Quality experience at a management level of site quality function

　　Working knowledge of MS Word, Excel, Outlook, and Power Point

　　Working knowledge of Adobe Acrobat

　　Functional Knowledge:

　　Excellent conceptualizing, analytical, people management and problem-solving skills

　　Effective written and oral communication skills

　　Strong organizational, planning, and communication skills.

　　Demonstrates exceptional time management skills.

　　Using logic and reasoning to identify solutions to problems.

　　Ability to multi-task, set priorities and meet strict deadlines.

　　Ability to lead, motivate, coach, and teach others

　　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 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.