Quality Integrated Management System Manager (ISMS) (m/f/d)

Born from the need to transport medication safely, innovation is in our DNA. Having recently celebrated our 10-year anniversary, we are a diverse and quality-conscious company, which has set itself the goal of transporting temperature-sensitive medicines in a more reliable and sustainable way. Long story short, we help save lives and preserve the environment.

Our goal? To continue to advance towards zero loss in the pharma supply chain, worldwide.

Due to our continued growth in the pharmaceutical market, we are seeking an experienced Q-IMS Manager to work with our Integrated Management System and software validation activities. This is an exciting and critical role within our company to ensure software excellence within a regulated environment.

Note that this role is cross-departmental and will thus require some travel in Europe on a quarterly basis.

Here's what you'll do:

Software Validation 

• Ensure the development and delivery of our supply chain platform and SkyCell’s IoT infrastructure is done in accordance with GxP requirements (in particular GAMP-5), including 21 CFR Part 11 and EU GMP Annex 11
• Lead software validation processes and documentation management within various software development methodologies (mainly Agile)
• Participate as QA Representative in the software development process, evaluating the GxP impact of software enhancements and fostering a culture of quality
• Lead certification process with third party auditors for GAMP-5, 21 CFR Part 11 and EU GMP Annex 11 (and other industry-relevant certifications)
• Support the embedded IoT team in obtaining approvals and certifications relevant for airline and pharma industries

Information Security 

• Transform ISO 27001 certifications currently maintained individually on business unit level to one aligned ISO 27001 certification on group level 
• and improve policies, guidelines and other documents related to ISO 27001 and support the IT service management function in improving processes around information security 
• Prepare ISO 27001 audits and support the IT service management function during the audit execution 
• Define and maintain SkyCell’s Data Privacy Policy and ensure EU GDPR compliance across all operations

Quality Management 

• Ensure ISMS is fully integrated in the corporate IQMS 
• Conduct internal audits and gap analysis to detect improvement potential 

Requirements

• Demonstrated experience in building systems compliant with ISO27001 standards
• Extensive knowledge of ISO27001 and related technical standards, including FDA 21CFR Part 11 and EU GMP Annex 11 
• Exceptional auditing skills and several years of experience in both internal and external audits
• Proficiency in software development methodologies such as Agile Scrum, with the ability to incorporate quality and compliance practices within an Agile framework
• Experience in corporate, process and project risk management (e.g. PMI-RMP Risk and/or several years' experience) 
• Project and change management experience 
• A strong continuous improvement mindset and experience in process improvements 
• Outstanding documentation, communication, leadership, and problem-solving skills 
• Excellent digital skills, ability to easily learn software tools and apply them effectively
• Familiarity with Quality Management System based on ISO 9001:2015 is advantageous 
• Willingness to undertake occasional business travel when required 
• Excellent English skills, both spoken and written 

Benefits

What we can offer you:

• Flexible working hours for work/life balance
• Interdisciplinary and varied projects
• Diverse and global work culture/ environment
• Possibility to work for an environmentally conscious company
• Unique opportunity to actively shape processes

Why SkyCell:

We are looking for people who challenge the status quo and thrive on making a difference to people and the world around us. That’s where our Improvement and Quality team play a pivotal role and you could be a part of it.

Our Improvement and Quality team are responsible for ensuring the highest standards of product and service quality. This involves implementing continuous improvement processes, conducting regular quality assessments, and analysing performance metrics to identify areas for enhancement. They collaborate with various departments to develop and refine protocols, ensure compliance with regulatory requirements, and facilitate training programs to uphold best practices. The main goal is to enhance operational efficiency, minimize risks, and guarantee the reliability and effectiveness of SkyCell's logistics solutions.

We are Innovative Award Winners:

We’re driven by our core values and guided by our collaborations, purpose, and employees. Our commitment to changing the face of medical supply chains, making them safer, more secure, and more sustainable resonates strongly with every one of our employees; we’re therefore incredibly proud to have been certified as a Great Place to Work alongside being awarded a sustainability rating of Platinum by EcoVadis.

If you would like to know more about us, visit www.skycell.ch and search #WeAreSkyCell on LinkedIn.

To become part of our journey and make a difference – click apply and we will be in touch!

Please contact Lucy Slough, Senior Talent Acquisition Specialist if you have any questions (hr@skycell.ch).

SkyCell AG is proud to be an equal opportunities employer, we celebrate and support diversity and are passionate about creating an inclusive environment for all employees. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, disability, or any other applicable legally protected characteristics.

For this position we only consider direct applications

Last updated on Jun 28, 2024