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.