Senior CMC Quality Auditor, Center for Vaccine Innovation and Access (8636)
January 8, 2018
Full Time - Experienced
Quality, Quality Engineering
Position available in Seattle, WA or Washington, DC.
PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms-vaccines, drugs, diagnostics, devices, and system and service innovations-that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.
PATH’s Center for Vaccine Innovation and Access brings together our expertise across every stage of the long and complex process of vaccine research, development, and delivery to make lifesaving vaccines widely available to children and communities across the world. CVIA’s current portfolio encompasses more than two dozen vaccines either in development or already in use to protect against 15 different diseases. Our focus is on vaccines to address the leading diseases that claim children’s lives worldwide: pneumonia, diarrheal disease, and malaria; as well as other global health priorities, such as polio and meningitis. We work in partnership with national health ministries, pharmaceutical manufacturers, donors, international financing and regulatory organizations, and many others.
PATH’s CVIA conducts vaccine development and associated technology research and vaccine introduction activities in the following disease areas: malaria, diarrheal diseases and polio, respiratory tract infections and meningitis, HPV and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization.
Supporting the implementation of cGMP Quality Management program within CVIA.
Leading and conducting internal & external GMP audits to monitor the state of compliance of service providers and internal departments and follow-up/track progress of findings as well as for proactive improvements and risk management; issue audit agendas, audit reports, findings, perform follow-up on CAPAs and closure; and escalate findings to management as necessary.
Supporting the hosting of external SMEs and regulators for auditing CVIA quality operations which support CVIA portfolio as well as contributing to optimizing strategy to ensure a continuous state of inspection readiness.
Providing administration activities for electronic quality management system (eQMS) for audit management and related cGMP activities.
Reviewing/identifying gaps during routine monitoring and continuously evaluate and improve performance of the GMP audit program by providing solutions.
Supporting the internal and external audit schedules, ensuring they are current and accurate, that audits are conducted, corrections are completed on time and metrics are evaluated and presented to management.
Participating in inspections/audits by regulatory agencies and partners; investigate and resolve observations as applicable to CVIA and PATH.
Supporting and maintaining the cGMP vendor qualification program and ensure the cGMP qualified vendor list is current and accurate.
Interfacing with departments/teams both internally and externally to ensure compliance in manufacturing.
Supporting project teams as a CMC representative to provide advice and support from a quality perspective for aseptic, sterile clinical trial materials and commercial manufacturing projects.
Reviewing Quality Assurance Agreements and Technology Transfer Agreements for suitability in working with Vendors/Partners/CMOs/CROs.
Providing Quality support to PATH partners as needed.
Review and approval on quality events (e.g., CAPAs, deviations, change controls, out-of-spec (OOS) results, etc.) for CMOs.
Interacting with and influencing colleagues in cross-functional areas (e.g., Clinical and Regulatory) to strategically align and facilitate harmonization of auditing processes and findings classification.
A Relevant Bachelor's degree plus a minimum of 8 years of experience in product development under cGMP compliant environment suitable for international regulatory submission and licensure.
Experience with pharmaceutical quality operations both in developed and developing countries.
Knowledge of vaccine and biologics development and manufacturing (cGMP) in developed and developing countries.
Experience in applying US and international quality requirements in the context of regional and international regulatory expectations.
Certified auditor (CQA) is highly preferred. ASQ, IRCA certified is a plus. Experienced at leading and participating in audits, strong FDA, EU and ROW regulation experience.
Conducting internal or external quality assurance auditing of manufacturing facilities (CMOs) and operations including analytical testing.
Proven ability to manage audit schedules and conduct audits as a lead auditor related to cGMP activities.
Knowledge of domestic and international relevant laws/regulations, legal codes, government regulations and agency rules. Includes the understanding of cGMP, ICH, some GLP requirements and current industry practices including validation and qualification of equipment, analytical instruments, utilities and computerized systems 21 CFR Part 11.
Comprehensive knowledge of quality systems and drug development from early stage to commercial pharmaceutical production environment.
Knowledge of computer systems and software, including relevant applications such as MS Word, Excel, and PowerPoint.
Fluency in English; other languages would be an asset. Excellent written and oral communication skills required.
Ability to work collaboratively in different geographical regions /cultures as necessary.
Ability to travel internationally and domestically up to 40 percent.
PATH is dedicated to building an inclusive workforce where diversity is valued. PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms—vaccines, drugs, diagnostics, devices, and system and service innovations—that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partn...ers around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health. Learn more at www.path.org.