Ardelyx, Inc.Waltham, Massachusetts, United States · Hybrid
$252k–$308k/yr
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-drive…
Skills: QMS strategy, Quality management systems, GMP, CAPA, Change control
Waltham, Massachusetts, United States · On-site
$47k–$52k/yr
The Cohen Center for Modern Jewish Studies (CMJS) at Brandeis University is seeking a research specialist to provide support for an interdisciplinary, forward-thinking team of researchers and scholars who conduct quantit…
Skills: Quantitative research, Qualitative research, Survey administration, Data coding, Team management
Waltham, Massachusetts, United States · On-site
Job Description Brandeis Hospitality is accepting applications to serve as a Student Sustainability Intern. The chosen applicant will have the opportunity to participate in educational outreach events and gain experienti…
Skills: Custodial maintenance, Housekeeping, Safety procedures, Equipment maintenance, Waste disposal
Waltham, Massachusetts, United States · On-site
$170k–$220k/yr
Crescent Biopharma’s vision is to build a world leading oncology company bringing the next wave of therapies for cancer patients. The Company’s clinical-stage pipeline includes its lead program, a PD-1 x VEGF bispecific …
Skills: Bioanalysis, Pharmacokinetics, Ligand binding, LC/MS/MS, CRO management
Waltham, Massachusetts, United States · On-site
Welcome to Pyramid Global Hospitality, where people come first. As a company that values its employees, Pyramid Global Hospitality is dedicated to creating a supportive and inclusive work environment that fosters diversi…
Skills: Customer service, Food service, Descriptive selling, Menu knowledge, Order taking
Waltham, Massachusetts, United States · Hybrid
PURPOSE AND SCOPE: The Customer Relationship Management Lead serves as the primary interface between the Global Real Estate & Corporate Security function and senior business stakeholders, including the Global Medical Off…
Skills: Stakeholder Management, Program Management, Real Estate Strategy, Corporate Security, Cross-functional Collaboration
Waltham, Massachusetts, United States · Remote OK
$180k–$250k/yr
Job Description A bit about this role: The Senior Director, Network Contracting is an executive operational leadership position responsible for directing and executing provider network contracting, deal closing, and unit…
Skills: Network Contracting, Commercial Managed Care, Medicare Advantage, Fee Schedule Optimization, Contract Negotiation
Waltham, Massachusetts, United States · On-site
$16/hr–$16/hr
HomeGoods At TJX Companies, every day brings new opportunities for growth, exploration, and achievement. You’ll be part of our vibrant team that embraces diversity, fosters collaboration, and prioritizes your development…
Skills: Customer Service, Cash Handling, Merchandising, Inventory Processing, Store Recovery
Waltham, Massachusetts, United States · On-site
Job Description Brandeis Hospitality is accepting applications to serve as a Student Sustainability Intern. The chosen applicant will have the opportunity to participate in educational outreach events and gain experienti…
Skills: Sustainability, Educational outreach, Waste reduction, Emissions reduction, Responsible sourcing
Waltham, Massachusetts, United States · On-site
$130k–$173k/yr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our coll…
Skills: Field Marketing, Market Development, Event Planning, Project Management, Stakeholder Management
Waltham, Massachusetts, United States · On-site
Pyramid Global Hospitality is a leading hospitality management company with a portfolio of more than 200 hotels and resorts and over 18,000 associates across the United States, Caribbean, and Europe. Our platform include…
Skills: Customer service, Sales support, Communication, Computer skills, Data entry
AT Process TechnologiesWaltham, Massachusetts, United States · On-site
$135k–$180k/yr
AT Process Technologies (ATP) is a pioneering manufacturing company focused on the development and deployment of modular energetics production plants. Using breakthrough chemistry and automation that operates continuousl…
Skills: Chemical engineering, Process engineering, Pilot plant engineering, Scale-up, Reaction engineering
Waltham, Massachusetts, United States · On-site
$18/hr–$26/hr
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Medical terminology, Patient care, Attention to detail, Communication, Interpersonal skills
Waltham, Massachusetts, United States · On-site
$17/hr–$24/hr
Site: The General Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As …
Skills: Therapeutic exercise, Patient care, Anatomy, Physiology, Infection control
Waltham, Massachusetts, United States · Remote OK
$122k–$205k/yr
Position can be remote. PURPOSE AND SCOPE: Fresenius Medical Care is seeking a highly skilled and experienced Infrastructure System and Network Engineer to join our team. The candidate will be responsible for managing an…
Skills: Network administration, System administration, Windows server, Linux server, Terraform
Waltham, Massachusetts, United States · On-site
$21/hr–$24/hr
Pyramid Global Hospitality is a leading hospitality management company with a portfolio of more than 200 hotels and resorts and over 18,000 associates across the United States, Caribbean, and Europe. Our platform include…
Skills: Culinary arts, Food preparation, Knife skills, Grilling, Sautéing
Waltham, Massachusetts, United States · On-site
$60/hr–$76/hr
We’re building a world of health around every individual — shaping a more connected, convenient and compassionate health experience. At CVS Health®, you’ll be surrounded by passionate colleagues who care deeply, innovate…
Skills: Pharmacy operations, Patient counseling, Immunization, Prescription fulfillment, Inventory management
Madrigal PharmaceuticalsWaltham, Massachusetts, United States · On-site
$170k–$203k/yr
Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need fo…
Skills: Legal operations, Board liaison, Project management, Governance, Compliance
Springwell, Inc.Waltham, Massachusetts, United States · Hybrid
Springwell is seeking an experienced onsite Administrative Assistant to join our growing Administrative Team! The compensation for this role is $25.64/hr for a 37.5 hour work-week. POSITION DESCRIPTION: The Administrativ…
Skills: Administrative support, Data entry, Reporting, Vendor audits, Contract documentation
Waltham, Massachusetts, United States · Remote Solely
$80k–$95k/yr
Job Description This role is fully remote and must be located within one of the contiguous 50 states A bit about this role: We want to help members navigate the healthcare system in a better and safer way, and we want to…
Skills: Diabetes education, Clinical assessment, Motivational interviewing, Care planning, Medication management
Ardelyx, Inc.
Waltham, Massachusetts, United States • Hybrid
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The Executive Director is responsible for the strategy, governance, and compliance of the company's Quality Management System (QMS) to ensure it remains inspection-ready and effective. They also lead the digital and data strategy, including AI integration, metrics infrastructure, and computerized system validation.
Candidates must possess a bachelor's degree and at least 15 years of quality experience in the life sciences industry, including 8 years of GMP experience. Strong expertise in QMS governance, regulatory compliance, and digital transformation is required.
The Executive Director, QMS and Digital is a senior leader within the Quality organization, reporting to the SVP, Head of Quality. This role is accountable for the strategy, governance, effectiveness, compliance, and continuous improvement of the Company’s Quality Management System (QMS), ensuring it operates as an integrated, reliable, and scalable system supporting a commercial-stage biotechnology organization.
This role serves as the enterprise Quality owner for the QMS, including governance, processes, and frameworks for document control and training, CAPA, change control, quality events and deviations and process excellence. The role is accountable for ensuring the QMS remains compliant, inspection-ready, available, and effective, with clear standards and ongoing evaluation of system performance.
This leader also owns the digital and data capabilities that enable a modern QMS, including Quality digital and AI strategy, Quality metrics and data infrastructure, and computerized system validation (CSV). The Executive Director leads and develop a team and partner across the organization to simplify processes, strengthen compliance, improve visibility and decision-making, and continuously advance Quality capabilities.
Responsibilities:
Qualifications:
Translating Scientific Breakthroughs into Promise for Patients
Ardelyx is a commercial-stage biopharmaceutical company focused on the development and commercialization of innovative medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). The company’s pipeline includes the Phase 3 development of IBSRELA for chronic idiopathic constipation (CIC) and RDX10531, a next-generation NHE3 inhibitor with potential application across multiple therapeutic areas. Ardelyx works with its partners to develop and commercialize its products outside of the United States. Community Guidelines: https://rb.gy/07ltg3
Offices: 400 Fifth Avenue, 210, Waltham, MA 02451, US · 7999 Gateway Blvd, Suite 110, Newark, California 94560, US · 260 E Highland Ave, Milwaukee, Wisconsin 53202, US
