BioVex Group Inc

Curent Vacancies

• Associate Director, Quality Assurance (US)
• Validation Manager
• Quality Assurance Team Leader
• Process Development Scientist / Engineer
• Manager/Sr Manager, Regulatory Affairs
• Sr Associate, Regulatory Affairs

Please send resumes to hr@biovex.com. No phone calls please
Associate Director, Quality Assurance (US)
Summary of Job Description: The Associate Director, Quality Assurance is responsible for the development, implementation and maintenance of Quality Assurance systems and activities at BioVex, Woburn.  Ensures all relevant quality and regulatory requirements are met for production and testing, and ensures site compliance with Quality System Regulations issued by FDA, MHRA and other applicable regulatory bodies where BioVex clinical or commercial products are in use.  Responsible for the evaluation and assurance that appropriate Quality Systems are in place at approved vendors and suppliers supporting GXP activities at Woburn in the US.  This position is responsible for management of Woburn QA activities.  Develops and manages the QA staff performing release and compliance functions.
Key Responsibilities:

• Oversees compliance and manufacturing QA functions ensuring the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards established by FDA, MHRA, and other applicable regulatory bodies. 
• Oversees and provides direction the Quality Assurance release and compliance staff at Woburn, and ensures QA functions are performed effectively.  Manage QA Document Control staff in Woburn. 
• Interfaces routinely with QA staff in Milton Park, UK regarding global Quality concerns.
• Support BioVex Clinical QA activities. 
• Interface with internal customers in Product Development, Quality Control Labs, Manufacturing, etc.
• Oversees or facilitates BioVex QA interactions with external vendors such as Contract Manufacturing Organizations, and other service providers to ensure compliance with BioVex requirements and GXP quality standards. 
• Provide support to Chemistry & Manufacturing Controls (CMC) regulatory activities, to facilitate FDA approval of the Company