Source Job

• Lead the development and execution of Care Access’s quality program across clinical, operational, and technology domains.
• Build and maintain a risk-based, fit-for-purpose Quality Management System (QMS) that supports Care Access’s mission.
• Collaborate with Operational Compliance, Product, Privacy, IT, and other functional partners to embed quality by design across systems and workflows.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, they bring world-class research and health services directly to communities that often face barriers to care.

• Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program.
• Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and clinical trials.
• Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business.

• Support operational planning, start-up, execution, and close-out activities for Phase 3 clinical studies in HCM.
• Oversee CROs, vendors, clinical sites, and external partners to ensure delivery of high-quality data, adherence to timelines, and compliance with GCP and regulatory requirements.
• Lead selection, onboarding, and oversight of CROs, central labs, imaging vendors, and specialty service providers.

Braveheart Bio is a Bay Area–based biopharmaceutical company pioneering best-in-class therapies for cardiovascular disease.

• Oversee the drug substance, drug product, reference standard, and packaging/labeling/serialization contract service providers for clinical-phase and commercial production activities.
• Review and approve key strategic product / process documents (i.e. specifications, batch records, tech transfer/validation protocols, etc.).
• Lead, review and approve change controls, deviations, temperature excursions, investigations, OOX, CAPA, and Product Quality Complaints.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. Their core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of their business and are exemplified by each and every one of their team members.

• Oversee clinical quality assurance, develop training programs, and ensure regulatory compliance.
• Design, implement, and oversee clinical quality assurance programs for in-home care delivery.
• Design and implement onboarding and continuing education programs for clinical team members.

Sprinter Health is an innovative healthcare startup dedicated to providing high-quality, in-home and virtual care across the country. They employ a multidisciplinary team of clinicians, technologists and operators backed by investors including a16z, General Catalyst, GV, and Accel.

• Develop, manage, and execute global clinical studies.
• Ensure timely and budget-compliant trial activities in accordance with quality standards.
• Lead the selection and oversight of clinical trial sites.

This position is posted by Jobgether on behalf of a partner company.

Lead all quality assurance and control initiatives for our brand implementation business, focusing on exterior signage and interior branding. Drive continuous improvement across design, fabrication, and field operations, ensuring the highest standards of craftsmanship and compliance. Champion a culture of quality excellence and customer satisfaction throughout the organization.

Stratus is the market leader in brand implementation and maintenance, transforming how national brands connect with their customers.

Accountable for the operational management and execution of global clinical trial programs (Phases I-III). Ensure adherence to GCPs, SOPs and all regulatory agency guidelines, as well as study operational planning and execution. Partner with CROs and other 3rd party vendors to oversee and ensure study milestones and deliverables are achieved according to agreed quality standards and timelines.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of inflammatory and immunology indications.

• Assist with the development of the protocol and informed consent form and/or program design.
• Manage vendor budgets, payments, and timelines.
• Effectively track and report on internal project metrics and study progress.

Tonix is a fully integrated biotechnology company, publicly traded on NASDAQ (ticker: TNXP), with marketed products and a pipeline of development candidates. They are focused on commercializing, developing, discovering, and licensing therapeutics to treat and prevent human disease and operates a state-of-the art infectious disease research facility. They provide a comprehensive compensation and benefits package.

• Manages central laboratory and specialty vendors across clinical trials.
• Provides support for sample related matters to clinical study teams.
• Assists with vendor selection and oversight.

Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind.

• Manage Apogee’s Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities.
• Serve as Apogee’s primary liaison with the in-house Oversight CRAs and Lead CRAs.
• Contribute to monitoring related process development, continuous evaluation of monitoring related resourcing, and the development and implementation of risk-based monitoring strategies.

Apogee Therapeutics is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease.

• Oversight for traveling clinical staff supporting decentralized operations at events and sites.
• Ensure high-quality protocol execution, participant safety, and adherence to GCP and FDA regulations.
• Manage, develop, and evaluate all clinical research staff (CRCs, nurses, mobile clinicians, and traveling staff).

Care Access aims to improve the future of health for everyone. With numerous research locations and clinicians globally, they deliver research and health services to communities facing barriers to care.

• Assist with daily site activities, acting as the primary point of contact for the site.
• Assist with training and mentoring research staff, upholding professional development goals.
• Promote strict adherence to ICH-GCP, FDA, and local regulations, maintaining audit readiness across all studies.

Care Access aims to improve the future of health for everyone. They operate globally with research locations, mobile clinics, and clinicians, bringing health services to communities, and are dedicated to ensuring every person can understand their health, access care, and contribute to medical progress.