Job Description

QUALITY CONTROL MANAGER

Location: Charleston, South Carolina, US

Reporting to: US Director, Quality

World-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Quality Control Manager is responsible for supporting the effectiveness and quality of product tested in Quality Control (QC) Lab, effective investigation and execution of the non-conforming material (NCMR) process, effective investigation and execution of the complaint handling process, and continuous improvement activities. This person must be able to lead a team focused on the activities defined above. The job holder ensures the applicable tools, techniques, and methodologies are used according to the company’s needs and applicable regulations.

Main Responsibilities

• Oversee the work of assigned team within the QC Lab including responsibilities on transfer, projects within manufacturing in collaboration with key stakeholders, oversee qualification of lab equipment, the development and validation of laboratory test methods in support of production and/or new product/process development.
• Manage project activities with the accountability for successful completion of all deliverables to the business and develop project plans, schedule, scope, and objectives.
• Identify risks, develop mitigation strategies, define alternative solutions, resolve issues, and follow-up on action items in collaboration with cross functional groups.
• Plan and lead the execution of laboratory activities to support supply chain and processes in accordance with applicable regulations, standards and guidelines.
• Lead in the monitoring and publishing of QC Lab metrics for the organization.
• Facilitate team to ensure laboratory specific investigations are performed in compliance with quality and regulatory requirements.
• Provide Quality Operations support in cross-functional workstreams leading to continuous improvement (e.g., Lean Six Sigma).
• Effectively transfer and implement the Complaint Handing process. Oversee the timely and effective execution of the complaint investigations. Lead in the monitoring and publishing of Complaint Process metrics for the organization.
• Effectively execute the non-conforming material (NCMR) process. Oversee the timely and effective execution of the NCMR investigations. Lead in the monitoring and publishing of NCMR Process metrics for the organization.
• Supervisory Responsibilities: Manage a team of 3 ( 1 QC Lab Supervisor and 2 QA Engineers)
• Oversee Quality Operations resources that the QC Lab, NCMR process and Complaint Handling process.
• Performs other related duties as assigned.

Skills and Qualification

• A Bachelor’s degree in science or engineering discipline (mechanical, industrial, biomedical, chemical engineering, material/life science) is required
• At least 5 years’ work experience in a in regulated environment (medical devices/diagnostic instrumentation industry, pharmaceutical or biotechnology industry)
• Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, with integrated/non-integrated testing.
• Test method validation and transfer
• cGxP Know-How incl. regulations ISO 13485, FDA 21 CFR 820, MDD 93/42/EEC
• Statistical methods
• Attention to detail.

We Offer

• Competitive compensation package

• Modern working environment with state-of-the-art facilities and technologies

• Challenging assignments in a fast growing and innovative industry

• Position in a dynamic, international team of highly skilled professionals

• Various opportunities for personal and professional development within a global organization

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