Quality Manager - Kitting
About the job
- A bachelor's degree is required; a master's degree in quality assurance, engineering, chemistry, or another technical field is preferred.
- At least 6 to 8 years of progressive experience in a regulated industry, such as medical devices, IVD diagnostics, pharmaceuticals, or a similar sector.
- At least 3 years of experience in people leadership or a managerial role.
- Demonstrated experience with regulatory inspections, certification-body audits, and/or customer audits.
- Strong knowledge of ISO 13485, 21 CFR § 820 (QSMR), and the European Medical Device Regulation (EU MDR).
- Ability to evaluate and continually improve quality management systems.
- Experience with systematic management of incoming, in-process, and final inspections.
- Practical knowledge of Six Sigma and Lean Manufacturing principles applied to quality systems.
- Ability to lead, coach, and influence employees and cross-functional partners.
- Strong oral and written communication skills, including the ability to communicate effectively with all organizational levels and executive leadership.
- Ability to prioritize and manage time effectively while handling multiple deadlines and delivering results on time.
- Ability to travel domestically and internationally up to 10%, as required by the site and business unit.
- Ensure site-level compliance with 21 CFR § 820 (QSR/QSMR), ISO 9001, ISO 13485, and applicable European Union medical device regulations and directives.
- Oversee implementation, integration, and ongoing maintenance of the quality management system (QMS), including implementation and administration of QMS software.
- Manage quality subsystems, including document control, training, complaints, corrective and preventive actions (CAPA), nonconformances, supplier management, and internal audits.
- Provide subject-matter support for creating, reviewing, and implementing procedures, work instructions, forms, and other process documentation.
- Coordinate and lead customer, regulatory-authority, and notified-body inspections and audits, including preparation, documentation, follow-up actions, and closure.
- Plan and conduct internal quality management system audits in accordance with ISO and QSR requirements.
- Oversee the supplier assessment and audit program and advise Procurement and Supply Chain on supplier quality issues.
- Serve as the quality subject-matter expert and provide expertise to internal teams and external customers.
- Manage the CAPA program and work with the lead auditor to ensure internal and external CAPA and audit programs are effective.
- Lead complaint investigations, including weekly review meetings and final review before closure.
- Oversee nonconformance management, including market corrective actions when needed.
- Implement effective root-cause analysis procedures across the organization.
- Evaluate current and emerging regulations and standards, and inform executive leadership of their impact and necessary changes across the organization.
- Identify, support, and lead continuous-improvement projects based on trend analysis, management reviews, complaint investigations, and audit findings, using Six Sigma and Lean Manufacturing methodologies to improve the quality system.
- Develop, implement, and maintain process improvements, key initiatives, and assigned projects.
- Manage preparation and facilitation of management reviews, and recommend data and metrics for executive leadership to monitor in support of strategic goals.
- Support validation programs and consult with Commercial and Product teams on the quality feasibility of new products; monitor product manufacturing processes and verify finished products meet specified requirements.
- Collaborate with other departments to align business and process activities with regulatory requirements and daily site-wide quality needs.
- Ensure appropriate staffing and work allocation based on site and department needs.
- Coach, develop, and assess the performance of direct reports and quality-team members throughout the year.
- Arrange and coordinate training on quality concepts, tools, and system requirements as needed.
- Represent the site leader during their absence as needed.
- Perform other assigned duties.
- A master's degree in quality assurance, engineering, chemistry, or another technical field.
About the company
Resonant Clinical Solutions provides outsourced clinical trial and diagnostic logistics for pharma, biotech, CROs, and diagnostic labs, offering end-to-end services through three lines: Kitting by Therapak for customized kit assembly, Equipment & Ancillaries by MESM for sourcing, delivery, calibration, and removal of trial devices, and Biorepository by EPL Archives for secure, temperature-controlled storage and archiving of samples. It operates an integrated platform that coordinates kit assembly, equipment management, and sample storage, now including cryogenic storage for complex therapies via Creapharm Bioservices. The company differentiates itself by bringing three established brands under one end-to-end partner with a global footprint and a track record with top biopharma customers and thousands of trials. Its goal is to be a dependable partner that lets clients focus on research and patient outcomes while growing Resonant as a standalone business.
Company Size
201-500
Company Stage
N/A
Total Funding
N/A
Headquarters
Claremont, California
Founded
N/A
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Simplify's Take
What believers are saying
- September 30, 2026 Labfish added IOR/EOR, calibration, and partner depots across 70 countries.
- September 3, 2026 Creapharm expanded GMP, GDP, and -196°C storage for cell therapy trials.
- Christophe Berthoux, appointed June 2025, brings NAMSA scaling experience and M&A discipline.
What critics are saying
- Audax integration across Therapak, MESM, EPL Archives, Creapharm, and Labfish risks service failures.
- Myonex, Avantor, and specialist rivals can undercut Resonant on price and global reach.
- A failed cross-border quality incident in 2026 would destroy trust with top-ten biopharma clients.
What makes Resonant Clinical unique
- Resonant bundles kitting, equipment, and biorepository services under one outsourced-clinical platform.
- Audax-backed carveout from Avantor created a standalone operator with 850 employees and 10 facilities.
- September 2026 Creapharm and Labfish acquisitions deepen European cryogenic storage and calibration capabilities.
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Benefits
Health Insurance
Wellness Program
Flexible Work Hours
Paid Vacation
Performance Bonus
Training Programs
Professional Development Budget
Company News
Resonant Clinical Solutions and Haier Biomedical have launched a benchtop centrifuge using natural refrigerant for clinical trials. The LX-60T100R employs hydrocarbon cooling instead of fluorinated greenhouse gases, complying with upcoming European and US legislation more than two years ahead of deadlines. The centrifuge reduces refrigerant global warming potential from over 1,400 in legacy systems to approximately 3. Key features include rapid pre-cooling to 4°C in five minutes, a 7-inch touchscreen, and quiet operation at 52 dB(A). The device is designed for pharmaceutical sponsors and contract research organisations, supporting blood collection tubes and containers up to 100ml. Clinical trial sponsors can purchase or rent the LX-60T100R exclusively from Resonant through November 2027, with the 220–240V model immediately available and the 110V version launching in Q1 2027.
Resonant Clinical Solutions expands its global activities in medical equipment and accessories through the acquisition of Labfish. Oct 02, 2026, 19:43 ET This acquisition strengthens Resonant's presence in Europe and brings it specialized calibration expertise, IOR/EOR coverage, as well as partner depots to support the clinical trial lifecycle globally LEESBURG, Virginia, October 3, 2026 /PRNewswire/ - Resonant Clinical Solutions ("Resonant"), a global partner specializing in clinical solutions serving life sciences organizations throughout the clinical supply chain and sample lifecycle, today announced it has acquired the German company labfish rental solutions GmbH ("Labfish") and its U.S. and UK subsidiaries, which together provide comprehensive clinical and laboratory equipment rental and calibration solutions. This acquisition expands the European presence of Resonant's Equipment and Accessories (E&A) business and enables it to better meet the needs of increasingly complex clinical trial programs around the world, through highly sought-after specialized expertise. Based in Hamburg, Germany, Labfish offers a wide selection of laboratory equipment for rent, including balances, freezers, refrigerators, infusion pumps, and monitors, as well as kits, consumables, and leading in-house calibration expertise. Labfish also offers importer of record (IOR) and exporter of record (EOR) services, as well as premium logistics management ensuring direct-to-patient delivery. The company collaborates with partner warehouses in Argentina, Israel, Turkey, and China to supply clinical trial sites in more than 70 countries. Founded in 2014, Labfish is ISO 9001 certified and operates one of the largest in-house calibration centers serving clinical trials in Europe. "The integration of Labfish within Resonant's E&A division allows us to expand our presence in Europe and strengthen our calibration and import-export services, further enhancing the world-class clinical trial solutions our clients rely on," said Christophe Berthoux, CEO of Resonant Clinical Solutions. "This acquisition continues the success of our Equipment and Accessories business, in order to meet the constantly evolving needs of our clients. The capabilities Labfish brings to Resonant enable us to advance our strategy of further supporting the clinical journey globally." The increasing complexity of clinical trial programs requires specialized equipment, calibration operations, and logistics support capable of adapting to evolving research protocols, workflows, and requirements. To meet this need, the acquisition of Labfish complements Resonant's existing E&A business, offering its partner clients a robust offering and technical expertise in Europe as their development programs scale. "Joining Resonant allows our team to further develop the calibration expertise, warehouse network, and import-export and logistics services that we have spent years establishing, while now having the necessary means to further support the clinical trial journey," said Martin Forster, founder of Labfish. "We are delighted to bring Resonant our technical expertise, strategic services, and valuable relationships with our clients." Financial terms of the transaction were not disclosed. About Resonant Clinical Solutions Resonant Clinical Solutions is a global partner specializing in clinical solutions, serving life sciences companies across the entire clinical supply chain and sample lifecycle. Through its biobanking, kit preparation, and equipment and supplies activities, Resonant helps its clients manage complexity, reduce risk, and support essential clinical programs around the world. With more than 850 employees across the United States, the United Kingdom, and Europe, Resonant has contributed to the completion of more than 2,500 clinical trials, has ensured more than 20,000 shipments to its clients' sites, and manages more than 100 million research assets in storage. The company works with pharmaceutical and biotechnology companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), as well as diagnostic and reference laboratories. Resonant's mission is to provide its partners with comprehensive and global clinical supply chain and sample lifecycle management solutions that simplify their processes and allow them to focus on scientific research and patients. For more information, visit resonantclinical.com.
Resonant Clinical Solutions has acquired Germany-based Labfish, a provider of clinical and laboratory rental equipment and calibration solutions. The acquisition expands Resonant's Equipment & Ancillaries business in Europe and enhances its global capabilities. Hamburg-based Labfish offers laboratory equipment rentals including scales, freezers, refrigerators, infusion pumps, and monitors, alongside kitting and ancillary supplies. The company provides Importer of Record/Exporter of Record services and works with partner depots in Argentina, Israel, Turkey, and China to supply clinical trial sites in over 70 countries. Founded in 2014, Labfish is ISO 9001-certified and operates one of Europe's largest in-house calibration facilities for clinical trials. The acquisition strengthens Resonant's ability to support complex clinical trial programmes worldwide. Financial terms were not disclosed.
/PRNewswire/ -- Resonant Clinical Solutions, a global clinical solutions partner serving life sciences organizations across the clinical supply chain and...