Manager QA Operations a BASEL

Randstad Professionals is looking for a Manager, QA Operations for a major client. This position will be based in Basel with some travel included in Switzerland.

Startdate: ASAP (up to 3 month notice period possible)

Contract: 12 months

Our client is dedicated to create a new class of transformative medicines for patients. The medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The companies platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing. Our client is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases , autoimmune and inflammatory diseases, independently and with strategic collaborators.

Your responsibilities:

• Support the QA Manager in plant QA presence at contract manufacturing organization (CMO) site in Visp to adherence to approved policies, SOPS, quality agreements, batch records, regulations and ensure timely documentation, notification/escalation and resolution of any issues and nonconformities

• Review and approve cGMP documentation (SOPs, protocols, technical reports, specifications, deviations, CAPA, change controls)

• Support quality investigations and manage CAPA (corrective and preventative actions) for CMO activities

• Review and coordinate approval of all changes made to the manufacturing, testing and control processes including those that are initiated by CMOs and Contract Laboratory Organizations (CLOs)

• Review batch records, testing records and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met and were conducted in accordance with regulatory filings, regulatory requirements and internal policies and procedures

• Review and approve method, equipment and process validation protocols and reports to ensure compliance with approved acceptance criteria

• Provide QA oversight at contract manufacturing sites to ensure compliance with approved quality agreements and overall cGMP compliance for the companie's drug substance and drug products

• Collaborate with manufacturing and testing contract facility personnel and internal subject matter experts in Manufacturing, Science and Technology (MS&T), Quality Control (QC), QA Systems and Compliance, QA Disposition, Supply Chain (SC) to support ongoing operational activities and resolve equipment, testing, and process issues

If you are interested to take on these responsibilities you should have the following requirements:

• Bachelor degree, preferably in Sciences or Engineering with applied Quality industry experience of 5-8 years

• Working knowledge of relevant EU and global regulations and ICH, ISPE, ASTM standards/guidelines and experience in hosting and facilitating successful regulatory inspections

• Experience in computerized systems, automation, operations and manufacturing and testing within biotechnology industry

• A proven track record of success in implementing and maintaining quality systems and e-systems in a biopharma organization

• Fluent in English and German language

• Excellent interpersonal skills using a team-oriented approach to project management and problem solving for complex issues 

• Outstanding communication skills (verbal and written) to all employee levels, executive leadership and external partners, suppliers, third parties, and industry organizations

• Experience working with different internal and external partners

• Ability to conceptualize, analyze, plan and manage multiple projects in a fast-paced environment 

• Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment

• Ability to navigate through ambiguity and rapid growth and adapt to change.

• A ‘digital first’ and curious mindset that allows you to constantly learn and challenge the status quo

Did we spark your interest? We look forward to receiving your online application.

Please note a Swiss Work permit is mandatory and your residence needs to be in Switzerland for this position.