Key Responsibilities

• Provide leadership, strategy, and compliance oversight in accordance with Good Manufacturing Practices (GMPs) for internal processes, GMP Service Providers, including but not limited to CMOs, Third Party Vendors, etc.
• Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, investigations, etc.)
• Authorship/review/approval of additional SOPs/policies for GMP/GCP regulatory compliance, where there may be gaps identified.
• Ensure compliance with the company’s procedures and training requirements.
• Facilitate GMP/GCP training of functional areas and develop appropriate training for personnel involved in the execution of related duties.
• Support the administration of the company’s training program in Learning Management system.
• Participate in the supplier qualification program and provide oversight of contractors and consultants to ensure timely and quality deliverables.
• Work with CMOs to create, and keep current with Quality Agreements, Quality issues to ensure quality standards are met, and resolve issues promptly and effectively.
• Reviewing and approving documentation such as Manufacturing Batch Records (MBRs), product specifications, change controls, deviations and CAPAs associated with the operations at the manufacturing facility.
• Provide support in reviewing Clinical packaging records.
• Develop and manage a risk-based Quality Management System for QA in compliance with applicable regulatory requirements (US) and company policies.
• Participate and provide guidance on any site and vendor-related quality issues identified.
• Support the coordination and management of regulatory agency inspections, and inspection readiness efforts which may include mock internal inspections and vendor audits.
• Manage inspection commitments, post-inspection activities, and corrective/preventative actions in a timely manner.
• Willing to assist with other duties as assigned.

Basic Qualifications:

• B.S. Biological Sciences, Chemistry or relevant discipline and a minimum of 8-10 years’ related experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience or an equivalent combination of education.
• Hands on experience with Electronic Document Management System (Veeva preferred), managing documents lifecycles-Draft to Effective/approved, Initial to Final and Periodic Review
• 5+ years of experience working directly within Quality Assurance/Quality Systems.
• Thorough understanding of Regulatory compliance requirements for the US FDA
• Familiar with Local, State, Federal, and international regulations
• Auditor training/experience or certification
• Strong understanding of risk assessment and risk management fundamentals/tools
• Team and consensus builder, with definitive and authoritative decision-making ability

Preferred Qualifications:

• B.S. degree or an equivalent amount of relevant experience
• 10-12 years of experience working within the Quality Assurance/Quality Systems, Clinical Operations, and/or Regulatory environment in the pharmaceutical or biotechnology industry.
• Proficiency with software applications such as MS Office, Smartsheet, Veeva.
• Proficiency in creating QMS SOPs, Good Documentation Practices, and quality review methods.
• Small or mid-size company experience and ready to lead project(s) with minimal supervision.
• Proven interpersonal and relationship building skills with the ability to work collaboratively as a member of a cross-functional team.
• Excellent organizational skills and the ability to manage concurrent deliverables and work effectively in a challenging, milestone-driven environment including leading/participating in projects.
• Ability to independently analyze/resolve moderate to complex issues and to seek guidance as needed.
• Effective written, verbal, and listening skills.