Quality Assurance Group Leader

Job Description

Eurofins BPT-Columbia is looking for a Quality Assurance Group Leader to join our Quality Assurance team located in Columbia, Missouri.  The QA Group Leader position is a mid-level professional position responsible for planning and managing the quality assurance group or program with the goal of improving quality processes and ensuring regulatory compliant development and testing services with Good Laboratory Practices (GLP) and/or Current Good Manufacturing Practices (CGMP) regulations. Works in GLP and/or CGMP areas of compliance.

• Responsible for management of day-to-day quality assurance activities within assigned team.  Serves to mentor, guide, advise, and otherwise support staff in their work.  Includes appropriate training and instruction. 
• Review staff work as necessary prior to submittal and sign-off.
• Formulates and maintains quality assurance goals and objectives complementary to corporate policies and goals. 
• Interprets and communicates GLP and/or CGMP quality philosophy to appropriate personnel within the organization. 
• Performs quality reviews of controlled documents to ensure GLP and/or CGMP systems are implemented consistently. 
• Works with Operations and Quality Management to develop, implement, maintain and interpret Quality metrics to improve Quality Systems.
• May serve as back up to Manager, Quality Assurance in times of absence. 
• Develops, implements, and reviews all quality systems.
• Mentors and trains GLP and/or CGMP quality assurance staff to develop a cross-trained staff of quality professionals.  Provides guidance and mentoring in the areas of conflict resolution.
• Schedules, coordinates, and hosts client and regulatory GLP and/or CGMP audits and responds to any audit observations. 
• Decides whether to accept a product or continue business with a supplier or subcontractor based on GLP and/or CGMP quality audit or review.
• Develops new approaches to solve problems identified during quality assurance activities. 
• Works with quality and operations management to develop and/or implement quality system improvement. 
• ·Performs internal and external quality audits.
• Manages workflow and workload of GLP and/or CGMP quality assurance staff, through prioritization and planning to assure that project, facility, and vendor materials are QA reviewed and/or approved in a timely manner. 
• Keeps management team informed of significant issues or developments identified during quality assurance activities and corrective action/preventive actions (CAPA) being taken to improve the situation. 
• Designs and implements quality training programs within QA and company-wide, as appropriate. 
• Investigates and responds to customer complaints regarding quality. 
• Drives investigations and CAPAs to completion.
• Reviews protocols, procedures, data, reports, and other documents to ensure accordance with specified regulatory requirements, protocol, and/or project plan, methods and SOPs.
• Works closely with study directors, principal investigators, and study owners to detect and resolve any quality issues. 
• Reviews standard operating procedures for accuracy and consistency to ensure agreement with regulations.
• Updates Master Schedule in accordance with specified regulations and standard operating procedures.
• Files protocols, amendments, deviations, inspections, and other quality documents appropriately.
• Performs other related duties as required and directed.

 The ideal candidate would possess:

• Experience with GLP and/or GMP and knowledge of HPLC and/or GC.
• Experience with LIMS system desirable.
• Experience reviewing Empower.
• Strong computer, scientific, and organizational skills.
• Demonstrated leadership and vision in managing staff groups and major projects or initiatives.
• A demonstrated commitment to high professional ethical standards and a diverse workplace. 
• Excels at operating in a fast pace, community environment. 
• Excellent people manager, open to direction and a collaborative work style and commitment to get the job done.  Ability to challenge and debate issues of importance to the organization.  Ability to look at situations from several points of view.  Persuasive with details and facts. 
• Delegates responsibility effectively. 
• Familiarity and/or experience in a laboratory setting is required.

Qualifications

• Bachelor’s degree and five (5) years of directly related (GLP and/or CGMP) experience is required, at least three (3) years of which includes GLP and/or CGMP Quality Assurance (not QC/R&D) work. 
• A degree in a relevant field such as chemistry, biochemistry, biology, chemical engineering, pharmaceutical sciences, or other directly related field or degree with comparable coursework is preferred.
• Supervisory experience is required. 
• Familiarity and/or experience in a laboratory setting is required.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Additional Information

Working schedule will be Full-Time, First Shift, M-F 8am-4:30pm. Candidates currently living within a commutable distance of Columbia, MO are encouraged to apply. No relocation assistance will be given. 25% travel may be required. This position is NOT remote. 

What we Offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.