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Manager, Regulatory Compliance - United States  

Company managed [?] Still accepting applications
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Posted on : 13 June 2017

Project Description

Company Statement
  • For nearly 70 years, our company  employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. 
  • When you join our family, you will have a significant impact on the health and well-being of people across the globe. 
  • Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. 
  • In return, we’ll help you build a career that you can feel passionate about.



Responsibilities
  • We are seeking an experienced Quality Manager in our Regulatory and Compliance Department for our Biologics Testing Solutions site.
  • Responsible for managing the Quality Assurance program component at a company operation.
  •  Assists Regulatory Affairs and Compliance management in implementing the company Compliance Program. 
  • Works with the site management team to assure regulatory compliance and consistency with company policies and procedures.
  •  Develop departmental policies and procedures to assure applicable regulatory requirements are fulfilled. 
  • Manage direct reports to assure that QA responsibilities of applicable regulations are fulfilled. Schedule resources to manage compliance systems and assure timely completion of:
    • audits of regulatory records and reports
    •  Inspections of facilities and equipment 
    •  Investigations; 
    •  audits of methods, practices, and controls. 
  • Assist in the development of short and long range operating objectives, organizational structure, staffing requirements and succession plans and all other duties.



About Biologics Testing Solutions
  •  With more than 50 years of experience and proven regulatory expertise, the  company  Biologic group can address challenging projects for biotechnology and pharmaceutical companies worldwide. 
  • Offering a variety of services such as contamination and impurity testing, protein characterization, bio assays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. 
  • Whether clients need stand-alone services, a unique package of testing, or in sourced support, our Biologic group can create a custom solution to suit their needs.  Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologic testing solutions team.



Qualifications
The following are minimum requirements related to the Manager of Regulatory Compliance position.
  • Education:   Bachelor’s degree (BA/BS) or equivalent
  • Experience:   Minimum of five (5) years experience in the pharmaceutical and/or biotechnology based industry.
  •   An equivalent combination of education and experience may be accepted as a satisfactory substitute for specific education and experience listed above. Experience in supervision of QA, QC, and/or regulatory affairs. Experience with assisting or managing QA audits and inspections as well as interfacing with regulatory agencies. Good working knowledge of pertinent regulations and site SOPs. Demonstrates strong leadership ability, communication, and facilitation skills.
  • Certification/Licensure:  Preferred.



About Us: 
  • For nearly 70 years, our employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies.  
  • When you join our family, you will have a significant impact on the health and well-being of people across the globe.  
  • Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. 
  •  In return, we’ll help you build a career that you can feel passionate about. 
  • Our company is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development.  
  • Our company also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities.  
  • Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market. 
  • With over 11,000 employees within 70 facilities in 18 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges.   
  • Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world. And in 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.  
  • We are passionate about our role in improving the quality of people’s lives.  
  • Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe.  
  • We have proudly supported the development of ~70% of the drugs approved by the FDA in 2016. 



Equal Employment Opportunity
Our company is an Equal Opportunity Employer M/F/Disabled/Vet