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13 days old

Associate Director, Quality Assurance

Kelly Services
Durham, NC 27722
**We are Kelly Science and Clinical** **,** the second largest scientific staffing firm in the U.S. serving 90% of Fortune 100 companies. We have partnered with a growing, award-winning biopharmaceutical contract development and manufacturing organization providing fully integrated, drug development and biopharmaceutical services to pharmaceutical and biotechnology companies globally.


**Job Title:** **Associate Director, Quality Assurance - (Biologics)**


**Overview:**


Built upon a foundation of world-class analytical capabilities, our client delivers efficient process development, clinical and commercial cGMP manufacturing services for mammalian, microbial, and cell therapy programs. Immediately seeking an Associate Director, Quality Assurance to manage QA activities supporting Analytical and Formulation Sciences and Microbiology in a contract development and manufacturing - (CDMO) organization.


**Responsibilities may include (but are not limited to) the following:**


+ Manage the Quality Assurance team supporting Analytical Formulation Sciences and Microbiology operations.

+ Supports GMP testing activities including release and stability testing.

+ QA Review/approval of method qualifications, transfer and validations, deviations, lab investigations, change controls and GMP technical documents.

+ Leads and directs the Quality Assurance team supporting Analytical Formulation Sciences and Microbiology Operations ensuring team meets expectations and objectives. Manage staff performance providing coaching and mentoring, and training relative to responsibilities.

+ Cultivate and maintain Quality Assurance staff by recruiting, training, and managing QA team members.

+ Works directly with Analytical Formulations Sciences and Microbiology departments to resolve deviations and other compliance issues in a timely manner.

+ Communicates directly with clients to resolve issues related to GMP testing.

+ Support Client audits and Regulatory inspections as needed.


**Education/Experience Requirements/Competencies** **:**


+ Legally authorized to work in the job posting Country.

+ B.S. degree and 10+ years experience **OR**

+ M.S. Degree and 8+ years of experience in a QA or GMP environment or equivalent.

+ Experience in a QA role supporting GMP analytical testing in the Biotechnology industry is required.

+ Experience managing a QA organization for both clinical and commercial operations is beneficial.


**Generous Compensation and Benefits Package Including Relocation Assistance**


**EOE, including Disability/Vets**


**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)
Posted: 2021-06-11 Expires: 2021-07-12

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Associate Director, Quality Assurance

Kelly Services
Durham, NC 27722

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