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9 days old

Executive Director of Quality Systems

Kelly Services
Sioux Falls, SD 57117
**Job Title:** Executive Director of Quality Systems


**Location:** Sioux Falls, SD

**Reports to** : Chief Compliance Officer

**Department:** Regulatory Compliance & Quality Systems


**Job Summary**

Our client is using the sophistication of science and genius of nature to change the landscape of human health. Our team of scientists, researchers and professionals has made it their life's workwith technology and tenacityto pioneer a new powerful platform to make an impact thats global + personal.


Through advanced genetic engineering and antibody science, we are dedicated to advancing a new class of immunotherapies, leveraging the native human immune response, with first-in-class and best-in-class potential across broad therapeutic categories including autoimmune, inflammation, infectious disease and immune-oncology. Our clients product, is among the elite therapy candidates for COVID-19, advancing with Operation Warp Speed. As true innovation, their novel platform is also being developed in a rapid response capacity for future pandemic response.


The Executive Director of Quality Systems position offers an exciting opportunity to establish and execute a Quality Management Systems Program to comply with current FDA regulatory requirements and guidelines and aligned with Company and Quality Systems goals. The Executive Director of Quality Systems has oversight for both Quality Assurance (QA) and Quality Control (QC) Units. This position will also be an integral collaborator and key member of the upper management team advocating and advising on all aspects of Quality to drive innovation and achieve Company goals.


**Essential Duties and Responsibilities:**

Leading Quality oversight to ensure the Quality Management System is implemented and maintained to regulatory and internal policy compliance.

Providing direction to QA and QC Managers to ensure programs and procedures are consistently followed and properly documented.

Building and mentoring the Quality Assurance (QA) and Quality Control (QC) teams by ensuring career development is provided along with appropriate training.

Establishing strategic objectives for QA and QC Units to meet regulatory and Company expectations and goals.

Overseeing the Quality Assurance and Quality Control Units to ensure product manufacturing and testing and out of specification investigations are completed in a proactive and timely manner.

Ensuring compliance to Quality Systems and managing the completion of QMS actions, deviations, investigations, root-cause analysis, CAPA, regulatory commitments, and audits.

Providing Quality oversight of contract manufacture and service providers to ensure they meet Company and regulatory compliance expectations, including supplier qualification, auditing, and QA agreements.

Working with the Regulatory Affairs Department in submitting submissions and supporting documents to the FDA Center for Biological Evaluation and Research (CBER) for investigating and licensure of biological products.

Ensuring Quality Risk Assessments are completed as required and validation activities are completed to meet regulatory and Company expectations.

Performing other related duties and assisting on other projects in quality departments or from other departments as needed based on Company needs.


**Supervisory Responsibilities:** Quality Assurance and Quality Control Unit Managers


**Qualifications:**

Five to ten years in a biopharmaceutical company

Extensive working knowledge and experience in Quality Assurance and Quality Control

Developed problem-solving and time management skills

Demonstrated success managing highly-productive teams to meet goals

Self-motivated and able to drive the progression of a successful Quality System

Ability to perform in a fast-paced environment

Exceptional organizational skills

Ability to both lead and foster a collaborative team environment


**Education, Experience and Certifications:**

Bachelors degree in biological sciences (chemistry, biotechnology, pharmacy, pharmaceutical technology)

Masters Degree in Quality/Regulatory Science, preferred but not required

Certifications in Quality Management Systems or equivalent a plus (SQA, RAP, etc.)

Management experience with ability to work constructively in a team to drive innovation while maintaining high Quality standards


**Language Skills:**

Must have excellent communication and writing skills with proficiency in Microsoft Office software (Word, Excel, PowerPoint and Outlook). Ability to effectively present information in one-on-one, small groups and meetings.


**Mathematical Skills:**

Utilizes established mathematical and scientific techniques to compile and analyze data.


**\#TJP2021_SPEC**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-09-13 Expires: 2021-10-14

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Executive Director of Quality Systems

Kelly Services
Sioux Falls, SD 57117

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