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Manager‚ Quality Assurance

Job Description
As the corporate business model exclusively utilizes contract organizations for all aspects of chemistry and manufacturing‚ nonclinical and clinical evaluation‚ the position plays a role in enabling vendor/contractor selection and will have subsequent oversight. While this position has key Quality responsibilities‚ there will be opportunities to support Regulatory Affairs. Job duties include:

  • Manage controlled documents.
  • Ensures documentation suitability against regulatory standards.
  • Review IND and CTA submissions to confirm compliance with approved practices and procedures.
  • Assist with the implementation of an electronic document management system.
  • Ensure corporate compliance with Quality System Policy.
  • Assist with internal compliance inspections.
  • Support the external GXP audits of contract vendors and organizations.
  • Participate as an active team member in the review process for requirements definitions‚ risk analysis‚ and validation activities.
  • Creates and revises internal Standard Operating Procedures and Policies.
  • Work with Product and Process Development Group to review and approve manufacturing and related documentation‚ including master and completed batch records‚ testing/release records‚ stability protocols‚ and other documentation generated by contract manufacturers in support of GMP operations.
  • Present information/reports to VP‚ Regulatory and Quality regarding the status of the company related to GXP standards.

Education

  • Bachelor’s degree from four-year college/university in Science or equivalent experience.

Skills

  • Detailed knowledge of current Good Manufacturing Practices‚ Good Laboratory Practices‚ and/or Good Clinical Practices.
  • Experience in setting up and management of documentation systems.
  • Experience in compliance auditing.
  • Ability to not only identify problems‚ but also recommend solutions.
  • Experience in training and implementing procedures compliant with FDA/ICH/WHO guidance or regulations.
  • Proficiency in Microsoft Office applications (e.g. Word‚ Excel and PowerPoint).
  • Excellent command of English language demonstrated by both verbal and written communication skills.
  • Ability to work in a small organization with aggressive timelines and multiple priorities.