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 companys 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 companys 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: