Serve as the enterprise Inspection Readiness Leader by defining strategy, policies, standards, governance frameworks, roles, responsibilities, escalation pathways, and operating models across all ARI sites and functions.
Design, implement, and sustain a standardized enterprise inspection readiness program, including lifecycle models for pre-inspection, active inspection, and post-inspection phases.
Provide enterprise-level oversight of inspection readiness posture, assess site readiness maturity using risk-based criteria and inspection indicators, and identify systemic inspection risks requiring enterprise remediation.
Serves as a dedicated strategic partner to assigned operational or functional business areas.
Translates business needs and regulatory expectations into effective, practical, and inspection-ready learning solutions.
Accountable for shaping learning approaches that support business outcomes, regulatory compliance, and inspection readiness.
Vertex Pharmaceuticals is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. They employ scientists, business professionals, and researchers united around a common goal–to discover, develop, and deliver innovative medicines.
Set submission strategy and operational timelines.
Build, evolve, and manage the Regulatory Operations infrastructure.
Establish and oversee training on RA procedures and submission standards.
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities. Mineralys is a fully remote company.
Lead GxP system qualification and validation activities for the eQMS, COTS, and TPS using a risk-based approach.
Administer and continuously improve eQMS quality event workflows - CAPA, nonconformance records (NCR), deviations, change controls, and document management.
Lead and maintain the Vendor Qualification Program and Third-Party System (TPS) audit schedule, including initial qualification, periodic requalification, performance monitoring.
Cogstate is advancing the science of brain health - making it faster, easier, and more accurate to assess cognition across clinical trials, healthcare settings, and everyday life. Our global team of experts spans psychology, data science, operations, and technology.
Collaborate with Clinical Operations, Clinical Development, and other departments on Risk Based Quality Management.
Identify and evaluate the remediation of fundamental risks and quality issues at vendors and clinical sites.
Develop and implement inspection readiness plans and procedures for Health Authority inspections.
Kailera develops therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, Kailera is expanding and seeking talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join the team.
Works with the Director of Quality Assurance to drive excellence and optimize audit and Inspection hosting.
Drives ongoing quality improvement measures through communication of audit results and compliance guidance/training.
Manages the audit and inspection hosting team.
PrimeVigilance, part of Ergomed Group, is a specialized mid-size pharmacovigilance service provider established in 2008. They value employee experience, well-being and mental health, acknowledging that a healthy work life balance is a critical factor for employee satisfaction.
Partner with GXP business leaders and translate objectives into comprehensive IT roadmaps.
Oversee selection, implementation, and validation of critical GXP systems.
Drive IT readiness for commercial launch including system scalability and disaster recovery.
Nuvalent is dedicated to creating selective medicines with the goal of addressing the needs of patients with cancer, leveraging deep expertise in chemistry. They are an early-stage company, bringing together experienced scientists and industry veterans with a proven track record in drug discovery, oncology drug development, and company building.
Design and/or enhance targeted and annual risk assessments.
Construct specific and effective auditing and monitoring workplans based on risks identified.
Analyze compliance outcomes and ensure detected issues are referred for remediation.
SmithRx is a rapidly growing, venture-backed Health-Tech company aiming to disrupt the expensive and inefficient Pharmacy Benefit Management (PBM) sector. With hundreds of thousands of members onboarded, they foster a mission-driven and collaborative culture, dedicated to transforming the U.S. healthcare system.
Develop and lead the enterprise compliance strategy aligned with institutional growth plans and regulatory expectations.
Oversee preparation and submission of substantive change applications and institutional reporting requirements.
Establish enterprise compliance training framework for corporate and campus leaders.
Cotulla Education transforms lives through hands-on, career-focused education. They empower students to achieve their professional dreams in high-demand fields. With experienced faculty providing personalized support, their graduates emerge as future leaders ready to make a significant impact.
Ensure the quality and compliance of clinical trials.
Interpret regulatory requirements.
Lead the development and implementation of quality assurance strategies.
Jobgether is a company, posting this job on behalf of a partner company. They use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements.
Define and execute global CMC regulatory strategies for investigational and marketing applications.
Lead preparation, review, and approval of CMC sections for regulatory submissions.
Ensure consistent interpretation of global CMC regulations and guidance; anticipate regulatory trends and risks.
BridgeBio is a biopharmaceutical company focused on discovering, creating, testing and delivering transformative medicines to treat patients who suffer from severe diseases. They employ a “moneyball for biotech” approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation.