Job Description

Description:

Reports to: Senior Director, Quality

Location: Remote Work

Position Summary:

The Director of Quality Assurance (Director) will provide leadership and management of Sabin’s R&D programs for operational, compliance and technical matters related to Sabin quality systems, quality assurance (QA) and quality control (QC), including but not limited to the selection, qualification and oversight of contract service providers consistent with applicable GMP, GLP and GCP regulations (GXP regulations), preparation, negotiation and implementation of quality agreements with manufacturing, clinical and nonclinical service providers and transfers of obligation between the sponsor and contract research organizations.

The Director will also be responsible to assure review and analysis of product characterization and release testing data, review and approval of master and executed batch records, equipment qualification protocols and reports, QC test results completion of internal and external auditing and preparation and approval of specifications. In addition, direct continuing implementation, maintenance and updating of Sabin’s quality system as appropriate, compliant with all current regulatory requirements and expectations using a phase-appropriate, risk-based approach. Lead the selection and management of consultants/contractors to execute the quality system requirements for generation, review and approval of supplier documentation and records for all GXP activities. In the interim, the Director will report to the Senior Director, Quality Assurance.

Responsibilities:

• Develop, lead and drive all GXP Quality aspects of Sabin’s projects; accountable for generating, managing and executing QA deliverables on time and in budget
• Manage and keep current all Quality policies, SOPs and the overall quality system, ensuring federal and other regulatory compliance
• Devise, train and guide the implementation of best practices for Sabin’s quality; ensure compliance with internal and external policies and regulations, as applicable
• Ensure appropriate quality issue management processes are established
• Manage quality improvement initiatives and risk management principles
• Evaluate quality risks of and recommend solutions to product and clinical safety issues during clinical phases
• Review data analyses and final study reports
• Manage the conduct and reporting of audits of contracted organizations to ensure compliance with domestic and international ethical and regulatory guidelines, as needed
• Prepare and sign off on quality agreements with all subcontractors, as needed
• Oversee all site QA/QC operations to ensure that assessment of materials, in-process production, shipment, lab activities, running of assays and sample testing is performed consistent with GXP, IND specifications and Sabin standards
• Serve as the primary QA/QC interface with regulatory, product, clinical and preclinical development teams, including QC assay development staff
• Build strong relationships and manage external QA/QC consultants in the delivery of their scope of work
• Supervise/manage direct reports and/or contractors/consultants as needed

Requirements:

• Advanced college degree in a related field
• 12+ years relevant experience, preferably with vaccine development and in the pharmaceutical or biotech industry
• Proven expertise with vaccine or biopharmaceutical cGXP
• Knowledge of the vaccine or biopharmaceutical development process, drug and biologics 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
• Demonstrated leadership and personnel supervisory/management skills
• Well-versed in creating and managing timelines and budgets, identifying risks and contingency planning
• Excellent verbal and written communication 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

Other:

Attributes that Are Important to Sabin:

• Diversity, Equity and Inclusion
• Problem-Solving and Critical Thinking
• Decision-Making
• Communication and Professionalism
• Initiative and Ownership
• Productivity and Quality Control
• Professional Development/Personal Learning

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.