• Responsible for direction and control of the site Quality Systems program, processes, procedures, system administration and training.
• Collaborate cross functionally to implement, oversee, and improve workflows for Change Control, CAPA, Deviation, and Product Complaints, including support and approval of robust root cause and impact investigations and resolution.
• Set, track, and trend site Quality Metrics.
• Primary Contributor to Quality Management Review to drive quality improvements by leveraging detailed data review as well as identification of action items.
• Implement and support Quality Risk Management process; drive and maintain site Risk Register.
• Implement and manage Clinical product retrieval and recalls program.
• Maintain Site Master File by template and collaborate with cross functional partners to drive content.
• Responsible for implementation and ownership of the site Quality Compliance program, processes, procedures, system administration and training including:
• Execution of the Supplier Quality Program, including the audit qualification and audit program, as well as establishing, monitoring, and reporting of supplier key performance indicators.
• Execution of the Internal audit program including evaluation of phase appropriate audit requirements.
• Drive and report site and contract service provider inspection readiness program, as well as site regulatory strategy and inspection management.
• Oversight and management of the QA Validation role and personnel to provide quality oversight, review and approval of all internal computer system validation initiatives.
• Other duties as assigned

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, abilities, and prior experience required.

• Strong knowledge of cGMP/ICH/FDA/EU requirements. Ability to assess compliance of regulations and industry standards, including phase appropriate controls and readiness for commercialization.
• Minimum 12+ years of relevant industry experience, ideally in all clinical phases through commercialization and a degree in pertinent life sciences
• Experience in running front and back rooms for agency inspections and setting up Inspection readiness programs
• Strong understanding of ICH, FDA, and EU regulations
• Exercise sound judgement in ensuring that written procedures are followed with proven ability in driving quality process improvement initiatives
• Independently motivated, detail oriented and good problem-solving ability
• Excellent communication skills, both oral and written to clearly and concisely communicate with internal and external team members
• Excellent interpersonal skills and ability to effectively collaborate in a dynamic project team environment
• Proficient computer skills required with experience using Microsoft Word, Excel, and PowerPoint
• Veeva experience preferred

The annual base salary for this role is $215K – $225K. Individual pay may vary based on additional factors, including, and without limitation job-related skills, experience, work location and relevant education or training. Pliant’s compensation package also includes benefits, equity, and annual target bonus for fulltime positions.