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 Essential Medicines (EM), which consists of the Center for Vaccine Innovation and Access (CVIA) and the Drug Development Program (DRG), conducts vaccine and drug development and associated technology research as well as introduction activities in the following disease areas: malaria, diarrheal diseases, polio, respiratory tract infections, neglected tropical diseases and meningitis, human papillomavirus (HPV) and vector-borne viral diseases, as well as in the cross-cutting area of Maternal Immunization.
The Sr. Clinical Quality Lead will be responsible for leading an effort to establish a Clinical Quality Unit within EM, spanning the development of sound plans and measures to ascertain clinical operational and document quality across the various activities through the progressive implementation of such measures.
The Sr. Clinical Quality Lead will work with other Quality counterparts as well as the CVIA Clinical, Regulatory and Chemistry, Manufacturing and Control (CMC) , and DRG teams, providing leadership in addressing Clinical Quality needs to support clinical, regulatory and product development activities
Responsible for Clinical Quality functions in support of PATH Essential Medicines:
- Provides leadership in the Quality arena to Clinical Operations. Will also work cross-functionally with Regulatory Affairs, Portfolio Management, Information Technology, and other supporting areas/development teams.
- Plans, establishes and continuously improves processes to ensure the quality of activities conducted at PATH Essential Medicines. Develops and oversees maintenance of GCP/ICH (International Counsel of Harmonisation) compliant processes that control the quality of work and clinical trials conducted at PATH EM.
- Provide subject matter expertise in regards to continuous improvement projects using approved tools, design control, validations, and ensuring adherence to the agency regulations and Good Clinical Practice/Good Laboratory Practice (GCP/GLP) guidance for the conduct of clinical trials of investigational vaccines and drugs. Ensures alignment and fulfillment with all regulatory checks on clinical quality measures within PATH EM and its external vendors.
- Collaborates on procedures and coordinates with Office of Scientific Affairs and others as needed to support and respond to internal quality audits, CAPA development and other quality management reviews.
- Provides expert advice and direction to CVIA and other EM research groups in responding to real or potential quality issues at external vendors and partners, including review of quality systems and documentation prior to award as well as of ongoing efforts.
- Has responsibility for the technical oversight of CVIA and EM contracts supporting clinical quality activities (e.g., knowledge management systems, external auditors). May participate in external auditing of vendors to ensure that studies are conducted in accordance with sponsor protocols, GCP/GLP industry guidelines, and regulatory agencies. May work with vendors to eliminate problems via root cause analysis techniques.
- Coordinate or provide training on various Quality-related topics (GCP, Audit readiness, GLP, etc.) to PATH EM staff. Works closely with Clinical Operations, Regulatory Affairs, CMC, Portfolio Management, Information Technology, and other supporting areas/development teams, to ensure active participation in quality improvement activities.
- Identifies non-conformances with requirements, provide suitable recommendations and facilitate ongoing quality improvements using risk-based methodology
- Leads/supports special projects requiring Quality Assurance/Quality Control (QA/QC) input.
The Statements made in the job description are intended to describe the general nature and level of work being performed by the person assigned to this job. These statements are not intended to be an exhaustive list of all responsibilities, duties and skills required of people assigned to this job.
- Master Degree, or Bachelor’s Degree plus equivalent experience, 10 plus years of combined experience with demonstrated capacity working in a senior role in a Quality Assurance area in pharmaceutical/vaccine product development.
- Three or more years of experience in the Pharmaceutical Industry, preferably vaccine/drug development.
- In-depth knowledge of regulatory requirements in the United States (US) and other International regulatory standards.
- Excellent knowledge of vaccine/drug development processes, and experience in support of New Drug Application/Biologics License Application (NDA/BLA) submissions.
- Strong analytical, problem-solving skills.
- Strong written and verbal communication skills.
- Detail oriented, with good organizational traits.
- Self-motivated, with strong leadership abilities.
- Results-oriented and quick learner.
- Good computer skills.
- Able to multi-task and respond to the urgent needs of the team and show a strong track record of meeting deadlines.
- Ability to work on multiple projects simultaneously and also have the flexibility of working both collaboratively and independently in a multidisciplinary project environment.
- In-depth knowledge of GCP/GLP/GMP Guidelines associated with the conduct of clinical trials.
- Proficiency in 21CFR11 compliance; experience in eCTD submissions desirable.
- Accreditation as Auditor, Clinical Research Associate or Clinical Trial Manager highly desirable.
- Willingness to travel within the US and abroad (up to 10% of the time).
SUPERVISION AND GUIDANCE
The selected candidate will serve under the supervision of the Global Head, CVIA Clinical and will be directly involved in an internal multi-office effort to address the quality needs at EM and develop and implement additional measures to strengthen them. Once assignments are provided by supervisor and the CVIA/DRG team, work will be planned and performed with a high degree of independence. Incumbent uses experience, judgment, and creativity in addressing unique problems using industry’s best practices. The incumbent’s professional judgment is relied upon to assume self-responsibility and -accountability for maintaining liaison with clinical, regulatory and CMC staff necessary to achieve overall objectives.
For more information and to apply go here: https://path.silkroad.com/epostings/