ParaPRO: Innovations in Life Sciences

ParaPRO Career Opportunity


Job Title: Quality and Regulatory Director
Business Unit: ParaPRO
Location: SePRO/ParaPRO Headquarters, Carmel, IN
Reports to: President, ParaPRO

Job Overview:

ParaPRO LLC is a new pharmaceutical company located in Carmel, IN and is a wholly owned subsidiary of SePRO Corporation. ParaPRO’s initial product offering, a pediatric medication for pediculosis capitis, has recently completed Phase 3 clinical trials and will be submitted to the FDA in 2008.  The Q&R Director will be a key driver in setting up the company for its first product launch in 2009 in a virtual company environment.

Job Responsibilities Include:

  • Developing and implementing a Quality System
  • Developing the Quality Manual and SOPs
  • Organizing the documentation library
  • Dispositioning batches of drug substance and drug product
  • Measuring and reporting quality metrics
  • Preparing for regulatory interactions
  • Conducting internal and external compliance audits

Currently regulatory compliance components have been managed by external contract organizations. These organizations will work with the Q&R Director to transition those activities.

Qualifications/Skills/Requirements:

  • BS in Engineering or a Scientific discipline
  • At least 5 years of experience in the pharmaceutical industry in Quality Assurance and Regulatory roles
  • Documented knowledge and experience to develop a Quality System based on Federal, State and International regulations for pharmaceutical manufacturers
  • Understanding of product development, manufacturing, sourcing, and servicing in the pharmaceutical environment
  • Experience working with key suppliers to provide ‘turn key’ product development solutions
  • Effective report, business correspondence and procedure-writing skills
  • Effective process development and project management skills
  • Knowledge of pharmaceutical terminology
  • Ability to compile and submit required documents to FDA (i.e. IND, NDA, meeting requests, clinical trial reports)
  • Experience with post-marketing requirements
  • Good problem identification, analysis and solving skills
  • Strong computer and e-skills
  • Lead Auditor certification and/or Regulatory Affairs Certification a plus

Ability to travel is required. The chosen candidate will travel to contract manufacturing, research, and supply organizations as required by the QA/QC components of the job. The primary regulatory consulting agency is located within walking distance of ParaPRO headquarters.

Benefits Include

  • Health Insurance
  • Life Insurance
  • Dental/Vision Insurance
  • 401(K) with 25% company matching
  • Additional Profit sharing via  401(K)
  • Access to medical/daycare pre-tax savings
  • Access to short-term and long-term disability insurance
  • Paid Vacation and Holidays

Please submit your resume and cover letter via email to Bill Culpepper III, Director of Corporate Development: bill3@parapro.com.

As with all employment application materials, receipt of such information does not obligate SePRO/ParaPRO to review or otherwise use such information.