Seeking a great opportunity with a leading Pharma CRO? Are you an expert in the regulatory and quality regulations?Are you a GMP Trainer? Do you have experience hosting and leading audits for FDA compliance? Experience with international audits-- includes India?
SC Novi
Hello! I am Shannon Flynn, PhD; I am a technical search consultant specializing in Pharma and Biotechnology.SC Novi is a premier recruiting and staffing firm active in the pharma/biotech, medical device, automotive, energy and industrial sectors with several great years of experience.We bring great new opportunities to scientists and great scientists to new opportunities. As a part of the MRI network, the world’s largest recruiting affiliate network, we can leverage recourses to find new opportunities, and help your career transition.For years SC Novi has been consistently recognized as a leading office within the MRI network.To learn more about our company, please visit our website at http://www.scnovi.com /.
Compliance Department Manager
My client is a leading Pharmaceutical CMO (cGMP) with over 100 years of manufacturing experience in Pharmaceuticals. They are a stable, full-service, 24 hour outsourcing provider of prescription and OTC medications. They have an opportunity for an experienced Pharma auditor to take on a leadership position with their team as the manager of the Compliance Department.The manager is responsible for oversight of both domestic and international audits to ensure compliance with FDA and international health authorities.This includes pharmaceutical regulations for manufacturing standards, procedures, SOPs, and marketing authorization.The position would have 4 direct reports with 6 people reporting into the direct reports
Position Responsibilities include :
·Manage oversight of both domestic and international audits to ensure compliance with FDA and international health authorities
·Develop, review and maintain audit standards
·Maintain assurance that all facilities, equipment, personnel, methods, procedures and records are within compliance
·Assure monitoring and management of clinical studies are compliant with regulatory standards
·Development and delivery of compliance training
·Provide recommendation for corrective actions
·Oversight and management of validation activities
·Provide technical expertise in all aspects of validation principals
Must Have:
·MS/PhD in Chemistry, Engineering or Pharma related
·8 - 10 years experience in Pharmaceutical manufacturing with some generics experience
·5 - 7 years experience in pharmaceutical auditing
·3+ years management experience
·Willingness to travel 25% (domestic and international- included travel to India)
Preferences:
·Strong Engineering and Pharma manufacturing background
·Cross functional experience in Pharma manufacturing
Compensation: (DOE) plus great benefits, and relocation.
If you are interested and qualified, let’s make it happen!
Founded in 2000, SC Novi, Inc. is a private, independently owned, national staffing organization based in Novi, MI. Our focus is the placement of professionals from entry level all the way up to the executive suite in the Automotive, Industrial, and Biotech sectors.
Our office has been nationally recognized within the world's largest affiliate network. We perform searches that work!
Our recruiters are educated, experienced, and deeply entrenched with companies in the Automotive, Industrial, and Biotech Sectors.
We have a proven process that helps industry leading companies find top industry talent.
To learn more about our organization, our people, our process, and our open positions, please visit www.scnovi.com.
MRINetwork is one of the world's largest recruitment organizations. Through our Accelerated RecruitmentT approach, we find and place Impact Players, those individuals who arrive faster, fit better and stay longer. Providing our clients immeasurable return on their hiring investment by bringing them the people who make a difference in their business every day. The combination of our global reach, industry expertise and streamlined methodology allows MRINetwork to match companies with their Impact Players - the right candidate for the right position.
MRI is a registered trademark licensed to Management Recruiters International, Inc. An Equal Opportunity Company
Each office is independently owned and operated.
Position ID: 45032
