Argos Therapeutics is a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases based on its Arcelis™ technology platform. Using biological components from each patient, Arcelis-based immunotherapies employ the patient’s dendritic cells to activate an immune response specific to the patient’s disease. After having met several important milestones including exciting clinical data, we are poised for new strategic objectives which will require significant new resources.
We currently have an exciting opportunity for a highly motivated colleague with the appropriate background in Quality Systems and current Good Clinical Practice (cGCP) to join a late-stage entrepreneurial biotech, and take a hands-on leadership role in helping to complete a Phase 3 program and bring a novel immunotherapy platform to cancer patients in need. The ideal candidate will have hands-on experience in clinical audits, regulatory inspections and come from a clinical Quality Assurance background. He/she will provide the vision and drive the implementation of the systems required to ensure GCP compliance and inspection readiness through process improvements across clinical development, clinical audits/inspections, the implementation of corrective and preventive actions (CAPAs), and revision/implementation of essential standard operating procedures (SOPs).
Key duties and deliverables of this position include building strong internal and external cross-functional collaborations with Clinical, Regulatory, Quality Assurance and Medical Affairs colleagues to ensure the compliant execution of our clinical development programs and successful achievement of our corporate goals. This colleague will be specifically responsible for performing internal and external quality audits ensuring compliance with all Food and Drug Administration (FDA), World Health Organization (WHO), Biological Licensing Agreements (BLA) and other regulatory guidelines, as well as our company policies/procedures. The colleague will take a leadership role in developing a comprehensive quality plan to ensure inspection readiness, and coordinate the development, training and compliance with clinical SOPs and standard operating procedures. Responsibilities include the maintenance of a clinical quality database for quality analysis, and the proactive assessment, identification and mitigation of compliance risks. This colleague will conduct study document reviews during and after completion of clinical study execution, and coordinate any appropriate corrective/preventive actions. This individual will perform technical document reviews and other cGCP activities in support of the clinical development programs in alignment with our corporate priorities. He/she will support Quality Assurance staff on GCP requirements and compliance, and provide audit reports to clinical and QA management.
- Manage all aspects of clinical compliance to ensure that all processes contributing to the conduct of our clinical studies are executed in a GCP compliant manner, and provide comprehensive oversight of external clinical compliance consultants and vendors.
- Develop a thorough inspection/audit plan for the oversight of internal/external clinical activities to maintain GCP compliance with global regulatory requirements/guidelines and an ISO 9001 Quality Management System.
- Collaborate with and oversee external suppliers/CROs to conduct audits; review/assess compliance status of contracted services related to clinical study execution and Medical Affairs activities.
- Perform regular, in-depth GCP audits of study data, documentation, informed consents, clinical study reports, data management, statistical analyses, and ethics committee submissions as appropriate and productively partner with Clinical Operations colleagues.
- Drive the process of responding to audit/inspection findings and develop appropriate CAPAs for study sites, systems and process audits, and inspections by external regulatory agencies (e.g. FDA, EMA, etc.) across Clinical Operations and Medical Affairs.
- Responsible/accountable for tracking and ensuring the timely delivery of all committed mitigation activities and deliverables to maintain the highest clinical quality and meet GCP regulatory standards.
- Maintain up-to-date knowledge of all global clinical quality-related legislation, guidelines, international/consensus standards, and compliance requirements.
- Responsible/Accountable to the Quality Review Board for GCP Compliance and the timely achievement of CAPA resolution targets.
- Lead and contribute to the development and execution of all clinical inspection readiness activities.
- Manage and maintain all databases for the clinical Quality System.
- Prepare clinical quality trending reports for oversight committee presentation and annual quality reports.
- Ensure appropriate tracking of process improvement initiatives and initiate, consult, implement and provide training (in association with relevant department managers) on agreed process improvement initiatives.
- Review, develop, and continually update clinical SOPs as needed in conjunction with the relevant department colleagues.
- Organize, lead, participate in contracted audits (study sites, CROs, trial master files, database, study reports) and internal audits (systems, processes, vendors, computer system validation) including the preparation of audit checklists, reports and certificates.
- Participate in the review of clinical protocols and clinical source data to ensure compliant execution of clinical studies.
- Efficiently and effectively partner cross functionally with Clinical Operations, Operational Quality Assurance, Regulatory, and Medical Affairs to ensure cGCP compliance.
- Establish GCP system/process training needs, develop appropriate training materials and deliver and document training compliance.
- Help to meet or exceed established timelines for all Quality Assurance deliverables.
- Control clinical QA activities, budget and expenses and efficiently manage resource allocations within scope and in alignment with company priorities.
- Bachelor’s degree in a related health sciences discipline; preference will be given to candidates with an advanced degree and strong Quality Assurance/Clinical Compliance training.
- Must possess a minimum of 8 years of experience with a minimum of 5 years in clinical quality assurance/compliance in the pharmaceutical or biotechnology industry, including hands-on experience with oversight of Quality Systems and GCP compliance, leading clinical quality audits, hosting regulatory quality inspections.
- Preference will be given to candidates with a combination of both direct CRO and Sponsor-side experience in effectively managing clinical Quality Systems.
- Ideal candidate will possess a thorough knowledge of Quality Systems and relevant FDA/ICH GCP regulations and guidelines governing clinical trial conduct and Medical Affairs operations with direct experience in Phase III studies and global regulatory interactions; preference will be given to candidates who have supported a successful BLA/NDA filing and product launch.
- Highly self-motivated problem solver with strong leadership and collaboration skills, a can-do attitude with a sense of urgency, who drives collaboration for results, takes initiative and personal accountability, effectively manages complexity and resourcefully deals with ambiguity.
- Clear written and verbal communication skills and sound interpersonal skills including conflict management.
- Outstanding project management, negotiation, and organizational skills.
- Demonstrated track record of collaboration skills with a successful track record of working in a matrix environment and valuing teamwork.
- Track record of effectively building strong relationships with external partners and through those entities, delivering high quality results.
- Strong communication skills (written and oral)
- Proficiency with SOP writing, root cause analysis and CAPA development.
- Excellent time management and organizational skills
- Ability/willingness to travel as required (approximately 60%).