JobWatch

8 days old

Associate Director of Quality Assurance

Kelly Services
Nashville, TN 37230
**Associate Director of Quality Assurance (Direct Hire) - Nashville, TN**


Reporting to the Director of Quality, the Associate Director of Quality Assurance will be responsible for oversight of department activities, development of personnel, and ensuring quality of deliverables. This individual will be recognized as an expert in the principles and application of quality assurance and compliance and will be responsible for development of strategic group goals and projects ensuring alignment with corporate goals and compliance with all regulatory requirements.




Responsibilities:



Support and maintain the PMI Biopharma Solutions Quality Management System (QMS)



Oversight of PMI Biopharma Solutions vendor management program Development of Quality Assurance team and individual development



Execution, coordination, and tracking of any assigned QMS procedures and related activities which may include internal audits, external audits, change management, document management, training management, batch review/release, deviation investigations, CAPAs, complaints, recalls, regulatory inspection management, quality risk management and management review coordination



Assembly, monitoring and/or presentation of QMS metrics updates and status reports



Develop and maintain compliant quality processes to support GMP activities



Participate in inspection readiness activities



Represent Quality Assurance during audits and perform internal and external audits



Qualifications:



M.S (or equivalent degree) and 4-6 years of relevant work experience, or a BS or BA in a scientific or related field (or equivalent degree) and 8+ years of biotech/pharma industry experience



Demonstrated success as a team leader with a focus of team and individual development



Experience providing QA support and oversight of GMP manufacturing for development programs including batch release of drug product



Experience with multiple regulatory agencies across applicable GxPs during inspections



Experience with investigations, root cause analysis, and CAPA



Contract Manufacturing Organization (CMO) or Contract Development and Manufacturing Organization (CDMO) experience desirable



Requires a minimum of 6 years of experience in Quality Assurance or Regulatory Compliance Management



Experience in pharmaceutical manufacturing environment; excellent knowledge of cGMP, ICH, USP, and global compendial regulations and regulatory guidance



Experience with scientific technical writing including authoring and revising SOPs or technical reports






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



With Kelly, youll have access to some of the worlds highest regarded scientific organizationsproviding you with opportunities to work on todays most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits youll be proud to help advance. We work with 90 of the Fortune 100 companies and found opportunities for more than 10,000 scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your careerconnect with us today.




**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. 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

Categories

Posted: 2020-01-10 Expires: 2020-02-15

Before you go...

Our free job seeker tools include alerts for new jobs, saving your favorites, optimized job matching, and more! Just enter your email below.

Share this job:

Associate Director of Quality Assurance

Kelly Services
Nashville, TN 37230

Join us to start saving your Favorite Jobs!

Sign In Create Account
Powered ByCareerCast