Reports to: Chief Operating Officer
Location: Washington, DC

Why Sabin:

Our mission is to make vaccines more accessible, enable innovation and expand immunization across the globe. We seek a future free from vaccine-preventable diseases. We are an innovative, collaborative and engaged team that values accountability, teamwork, partnership and driving impact. We are vaccine champions improving lives through immunization.

Position Summary:

The Sabin Vaccine Institute (Sabin) is seeking a Senior Director of Quality Assurance and CMC Oversight to join its Vaccine Research & Development (R&D) Team. The Senior Director will be in charge of all aspects of Sabin’s quality assurance (QA) activities, including establishing, implementing and ensuring the QA in our vaccine development initiatives. The Senior Director will have a proven track record with vaccine cGXP expertise and experience in CMC. Sabin aims to drive vaccine candidates through licensure; the Senior Director will leverage their robust set of experiences and qualifications to achieve this objective. Title and salary commensurate with qualifications and experience.

Responsibilities:

Quality Assurance/Quality Control Management

  • Develop, lead and drive all QA aspects of Sabin’s projects; accountable for generating, managing and executing QA deliverables on time and in budget
  • Manage all QA policies, SOPs and the overall quality system and ensure federal and regulatory compliance
  • Devise, train and guide the implementation of best practices for Sabin’s QA; ensure compliance with internal and external policies and regulations, as applicable
  • Ensure appropriate quality issue management processes are established
  • Establish quality and reliability standards by studying product and consumer requirements
  • Manage quality improvement initiatives and risk management principles
  • Establish raw material standards by studying manufacturing and engineering requirements
  • Establish in-process product inspection standards
  • Prepare product and process quality reports by collecting, analyzing and summarizing information and trends
  • Evaluate quality risks of and recommend solutions to product and clinical safety issues during clinical phases
  • Review the data analysis and final reports for studies
  • Exercise cost-effective quality and regulatory compliant methods in selecting program partnerships
  • Assist in identifying and managing external partners, subcontractors and consultants relating to quality matters
  • Establish and manage the tracking system for document control

Quality/Product Development and Manufacturing Oversight

  • Conduct and report audits of contracted organizations to ensure compliance with domestic and international ethical and regulatory guidelines, as needed
  • Prepare and sign off on the quality agreement with all subcontractors, as needed
  • Manage all site QA operations to ensure that assessment of materials, in-process production, shipment, lab activities, running of assays and sample testing is performed consistent with cGXP, IND specifications and Sabin standards
  • Serve as the primary QA interface with regulatory, product, clinical and preclinical development teams
  • Support the preparation and submission of quality/regulatory applications with regulatory authorities, including the review and compilation of CMC and other quality documents
  • Assess the acceptability of quality, preclinical, manufacturing, testing and clinical documentation in support of the total quality management system and, when applicable, suitable for submission filing to regulatory agencies
  • Establish, lead and manage the CMC development plan and lead the execution of the plan for vaccine substances and products from pre-clinical through commercial development
  • Work with Grants & Contracts Manager and others, as needed, to identify and negotiate with qualified subcontractors
  • Direct/oversee contract manufacturing, testing, packaging and labeling and ensure regulatory and QA compliance
  • Guide external operations through tech transfer, process and method development, optimization, qualification and validation of the activities related to all manufacturing operations
  • Maintain knowledge of current best practices of biological manufacturing
  • Review and approve master and executed batch records from all manufacturing activities; analytical release testing, stability studies and investigations, as required
  • Develop production plans to support preclinical, clinical, and commercial development and adjust plans as appropriate to meet organizational objectives

Organizational and Mentorship

  • Provide comprehensive project analysis to senior management as required in the form of reports or presentations, as needed
  • Responsible for personnel training and recordkeeping per SOPs, ensuring that required documents are up-to-date
  • Contribute to report deliverables to funding agencies/funders
  • Contribute to product development plans in support of funding applications
  • Advise and support all cross-functional needs (regulatory, clinical, preclinical, manufacturing, project management, etc.)
  • Support recruitment of qualified talent, supervise, mentor, coach and train team members, as assigned
  • Represent Sabin and promote its mission at events and meetings
  • Other related duties, as assigned

Requirements:

  • Advanced degree in a related field
  • 16+ years relevant experience, preferably with vaccine development and in the pharmaceutical or biotech industry
  • Proven expertise with vaccine cGXP
  • Proven CMC experience 
  • Knowledge of the vaccine development process, drug laws and global regulations and requirements
  • Strong analytical skills, problem solving ability and presentation skills
  • Flexibility and ability to prioritize and manage multiple tasks simultaneously
  • Well-versed in creating and managing timelines and budgets, identifying risks and contingency planning
  • Proven ability to manage people, build relationships and understand what motivates others
  • Excellent verbal and written communicator with ability to tailor approach toward the perspective of others
  • Demonstrated ability to interact effectively with individuals at all levels, including Boards of Trustees, coalition partners, staff and organizational contacts; excellent at working closely with others over geographical distance
  • Strong attention to detail, ability to manage complex tasks, highly organized, dependable and able to prioritize competing demands in order to meet deadlines

How to Apply:

To be considered, please submit your cover letter and resume via e-mail to [email protected]. Please be sure to reference “Senior Director, Quality Assurance & CMC Oversight” in the subject line. Your cover letter should: (1) address the reasons for your interest in this position; and, (2) describe the knowledge, skills and abilities you would bring the Sabin Vaccine Institute. No phone calls, please. Only short-listed candidates will be contacted.

Title and salary commensurate with qualifications and experience. Sabin Vaccine Institute has a generous benefits package.

Sabin is an Equal Opportunity Employer. All applicants will be considered for employment without attention to their race, color, religion, national origin, ancestry, age, disability or genetic information, sex (including gender identity, pregnancy or sexual orientation), marital status, veteran status, or any other characteristic protected by applicable federal, state or local laws.