Job Purpose:
This position is responsible for establishing and maintaining an effective regulatory compliance function to ensure adherence to applicable GXP regulations, Theravance quality system requirements, State DHS requirements, and GXP training program.  The incumbent will be responsible for coordinating all internal and external audits, developing annual audit plans and budgets, tracking and trending CAPAs for timely closure of audits, and monitoring CRO, CMO, and contract test lab regulatory inspection status between Theravance audits. The incumbent will also provide technical support with ad hoc investigations and/or targeted training as directed by the VP Quality.

Duties and Responsibilities:
Major Accountabilities include-
• Develop a formal Corporate GXP compliance program that will define the requirements, processes, templates and tracking systems for an internal and external audit program
• Develop and maintain a GXP training program for new and existing employees.  Provide targeted compliance training as needed
• Stay current with GXP regulations, guidelines and industry practices and provide management and customers timely updates, impact assessments of changes to regulations, and recommendations for meeting new requirements
• Establish and maintain contract provider regulatory compliance status between Theravance audits.  Provide periodic updates and advise management of any adverse trends in a timely manner  
• Responsible for establishing cross-functional teams and training of team members to perform internal audits as deemed necessary
• Responsible for leading / coordinating preparation of planned regulatory inspections (PAI, routine inspections, etc.)
• Act as the primary contact with GMP contract providers during audits of those sites by regulatory authorities and provide management timely updates.  Coordinate with GCP Director to report on said activities of CRO and clinical site audits.
• Act as lead coordinator/contact during regulatory or due diligence audits of Theravance
• Maintain central GXP audit files, CAPAs, trends and audit certificates
• Provide technical support on ad hoc investigations as directed by the VP Quality

Key Attributes and Performance Indicators:
• Must have strong organizational skills, possess excellent written and verbal communication skills and attention to detail
• Self starter and an ability to work with minimal supervision
• Strong technical and GXP background
• Proficient with MS Word, Excel, Access and other software tracking/trending tools

Qualifications:
• Minimum BS/MS degree in science, engineering or a related field with 10+ years in the bio/pharmaceutical industry
• 5+ years in a management level role in Quality Assurance or Compliance
• Experience in auditing techniques (ASQ certification is a plus)
• Must poses expertise in one or more of the following GXP areas with a
  working knowledge of GMP, GLP, and GCP regulations, guidelines, etc.