The Manager, Quality Assurance & Regulatory will support global quality systems, product integrity, and regulatory compliance. Heavily focused on quality assurance, including product testing, technical packaging, supplier quality management, and continuous improvement initiatives. Partner closely with Product Development, Operations, Packaging, Creative, and Customer Experience to ensure products meet Starface’s high standards.
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.
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.
The FS QA Learner will support the FS QA team and ensuring compliance across our operations. You'll have the opportunity to work with a diverse range of suppliers and gain practical experience in document review and approval. The ideal candidate is highly detail-oriented and eager to learn the ins and outs of quality systems for a growing brand.
Chomps is the fastest-growing snack brand in the U.S. and they’re reimagining snacking with meat snacks made using high-quality proteins, no sugar, and real ingredients.
Support software validation and verification efforts to ensure compliance with FDA regulations and industry standards.
Own the quality approval process for software components, including documentation review and final release approvals.
Partner with the software engineering team to implement and maintain a robust software quality management system.
Sequel, headquartered in Manchester, New Hampshire, is developing the next generation of transformative drug-delivery advancements starting with diabetes. Sequel’s approach is to look at diabetes management holistically to advance systems that make living with diabetes simpler and easier for all. Sequel provides equal employment opportunities and believes that when you thrive, they thrive.
Oversee quality controls, manage internal audits, and ensure student finance compliance with regulatory requirements. Manage quality assurance processes for Student Finance and cross-functional teams, promoting a quality mindset across the organization. Develop and implement quality strategies and goals and conduct audit reviews to identify and drive process improvements.
American Institute provides hands-on training for careers in the world of business, legal, allied healthcare, diagnostic medical sonography, and IT.
The Upstream Senior Clinical Program Manager will design and execute pre-market feasibility and pivotal clinical studies, ensuring regulatory compliance while supporting marketing claims. This role requires close collaboration with physician collaborators and internal stakeholders to collect, analyze, and interpret clinical data. The role offers remote flexibility, with occasional travel for on-site meetings and conferences.
This position is posted by Jobgether on behalf of a partner company.
Ensures the quality of printed products from initial design to the final customer product. Involves hands-on inspection, data analysis, and collaboration with a network of PSPs. Maintains high standards and improves key metrics.
Minted empowers a thriving community of independent artists to sell and scale their work by nurturing self-expression, cultivating community, and bringing the best in visual art to a global audience.
Complete monthly utilization management and appeals performance and process audits.
Present audit results to leadership to address issues.
Assist management in identifying, evaluating, and mitigating risks.
Judi Health provides a comprehensive suite of solutions for employers and health plans. They offer full-service health benefit management solutions and consolidate all claim administration-related workflows in one scalable, secure platform.
Owns the CAPA system and leads as the Subject Matter Expert (SME).
Leads cross-functional teams in facilitating CAPA Boards and Root Cause Analysis teams.
Monitors KPIs and drives systemic improvements to ensure products meet the highest standards.
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
The Senior Safety and Compliance Specialist ensures compliance with UK and EU product safety, Dangerous Goods (DG), and Fulfilment House Due Diligence Scheme (FHDDS) tax requirements. Partners cross-functionally with internal teams and external regulators to ensure products, distribution centers, and merchants meet legal and regulatory standards. Serves as the main liaison to UK Trading Standards and HMRC for product safety and tax compliance matters and supports DG program development and operational readiness for the UK network.
ShipBob is a leading global supply chain and fulfillment technology platform designed for SMB and Mid-Market ecommerce merchants.
Drive execution of NPI strategy to develop scalable, high-yield processes.
Optimize inspection strategies through technology, automation, and supplier certification.
Coach and develop a team of quality engineers to meet performance metrics.
Stryker is a leading medical technology company committed to improving healthcare. They offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine. They are proud to be named one of the World’s Best Workplaces!
Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.
GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.
The Regulatory Document Coordinator will have primary responsibility for document management activities supporting Regulatory Affairs. Key responsibilities include word formatting, PDF publishing, eCTD output review, submission archival, and document workflow management. This position will play an integral role in the execution of the Regulatory strategy world-wide, with multiple avenues for continued development.
Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care