Kelly Services Clinical Quality Systems Manager in Ashburn, Virginia
Kelly Scientific is working with a clinical-stage biotech firm with a robust pipeline that is building a Clinical and Regulatory team. This is an opportunity to get in on the ground floor with growing company. We are searching for a Quality Systems Manager. This is a direct hire (NOT contract) opportunity. Mission critical for this role is the ability to comprehend and implement a Clinical Quality System that encompasses all GXP, GCP and ICH requirements and guidelines. Ability to work with, understand and push back on CRO's when necessary is also important.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Develop, implement, manage, audit and maintain GXP quality systems to support developmental and commercial activities
Provide leadership to and manage the daily activities of the QA Systems and Compliance.
Demonstrate leadership by ensuring the continuous improvement of the Quality Management Systems at CMOs, Clinical Supply vendors, contract test labs and clinical sites.
Ensure management of changes associated with products and processes are carried out appropriately using scientific and risk-based assessments to assess the impact of change.
Manage the Internal and External Audit programs to ensure Suppliers are in compliance with applicable regulations. Coordinate and perform all vendor qualification and compliance audits.
Coordinate activities and support interactions during regulatory agency inspections and customer audits. Work across all disciplines (e.g. manufacturing, clinical, R&D, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
Develop, manage and maintain a GXP compliant document control system.
Be a Subject matter Expert for interpreting regulations and applying them to compliance situations as applicable for Phase 1 to 3 drug development programs and or commercial drug manufacturing, testing, packaging and distribution.
Minimum BA/BS in life sciences (Biology, Chemistry), Advanced degree preferred.
A minimum of ten (10) years of experience in the pharmaceutical or biopharmaceutical industry with increasing levels of responsibility.
A minimum of five (5) years relevant experience in a Quality leadership function (QC or QA) is also required.
Experience establishing and managing Quality Systems is preferred.
Hands on experience in writing SOPs
Demonstrated ability in problem solving, strong understanding of cGMP and GxP.
NOTE: Please submit resume in MS WORD format
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 interests—it’s 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, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.