Quality Assurance Manager
Vor 4 Tagen
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The PositionAt Roche, 94,000 people in over 100 countries work towards the future of healthcare. Together, we have become one of the leading research-focused pharmaceutical companies. Our success is based on innovation, curiosity, and diversity.
The Kaiseraugst production center (PTGA) ensures patients have faster access to our high-quality medications. Our site represents the highest standards of pharmaceutical manufacturing and is the largest, most innovative packaging center of Roche, supplying over 120 countries.
The Quality Unit in Kaiseraugst/Basel consists of Quality Assurance (QA), Quality Control (QC), Quality Systems (QS), and Quality Compliance and Issues. We ensure the quality and compliance of over 40 product families for more than 120 countries in an integrated Drug Product and packaging site. We are also responsible for centralized QC and the release and stability testing of sterile and non-sterile products, as well as starting and packaging materials.
Our philosophy is that quality is a right for every patient, and we take responsibility for contributing to it.
Your Opportunity
We are looking for several QA Managers in the following departments:
Quality Assurance for the production of pre-filled syringes, liquid and lyophilized forms, solid dosage forms, and sterile powders.
Quality Assurance for logistics, warehousing, and master data management.
Quality Assurance for Quality Control (QA for QC).
As a QA Manager, you, together with your colleagues in the QA team, will be responsible for ensuring that our products meet the specific requirements and that releases comply with both legal conformity in customer markets and internal Roche Pharma Quality Standards (PQS). You will be the expert for all quality-related questions and the link between production operations and other relevant interfaces.
Your responsibilities include:
Ensuring Quality Oversight in production facilities/QC through QA inspections and participation in and support of self-inspections and regulatory audits.
Release of manufactured or purchased commercial drug substances, bulk goods, finished products, or direct materials, considering all GMP and regulatory requirements, including Roche guidelines.
Reviewing and approving manufacturing instructions and Master Batch Records (MBR).
QA responsibility and handling of deviation reports, CAPAs, and changes.
Implementing and advancing ideas for improving quality, efficiency of facilities and processes, and cost reduction using Lean Production System (LPS) methods and tools.
Close collaboration with internal and external interfaces to achieve our ambitious goals regarding quality, lead time, engagement, and costs.
Training and taking on new tasks in adjacent areas for versatile development.
Compliance with all safety and environmental regulations and consciously promoting operational safety.
Creating, approving, and training on SOPs and other GMP-relevant documents and processes.
Who You Are
You are a positive, integral, and self-reflective individual with strong teamwork skills and an open and quality-oriented mindset necessary for successful collaboration in your team and across departments. You act proactively and are characterized by your hands-on mentality. You trust yourself and others, take responsibility, and foster an open speak-up and error culture. Furthermore, you are willing to work with a high degree of personal responsibility in an open, constructive, and collaborative environment.
Your solution-oriented attitude and "Can-Do" approach guide your daily actions.
As a QA Manager, you ideally have several years of professional experience in pharmaceutical production, development, or quality assurance/control, preferably in bulk manufacturing and/or packaging. You hold a degree in pharmacy, natural sciences, engineering, or have a relevant vocational qualification combined with extensive professional experience in the GMP area. Moreover, you possess solid knowledge of applicable GMP regulations (e.g., Eudralex Vol 4, ICH Guidelines, FDA cGMP Guidelines).
Additionally, you possess the following competencies and skills:
Quick comprehension and strong interest in technical processes, as well as proficiency in using IT systems (e.g., Google applications and relevant GMP systems such as SAP, Pharmasuite, Veeva).
Strong willingness and curiosity to develop flexibly and learn across departments for versatile development, including an interest in understanding and improving upstream and downstream process steps.
A team-oriented mindset focused on continuous process improvement and the ability to maintain consistent high performance in a constantly changing environment.
Knowledge and committed application of process improvements (e.g., LPS) and Agile Management is an advantage.
Ability and openness to recognize and embrace the opportunities and advantages of changes, with an interest in coaching and change management being beneficial.
Strong communication skills (both written and spoken in German and English).
Willingness to participate in on-call duty (standby duty).
Are you ready to apply? We are looking for someone who thinks beyond the advertised position – someone who recognizes that this role can be an outstanding opportunity to shape the future of Roche.
Who We AreAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity, and diversity.
Roche Kaiseraugst is a cornerstone of Roche's global production and logistics network. It employs some 1,900 people out of the 10,700 employees at our Basel/Kaiseraugst site and is Roche's largest and most innovative packaging facility worldwide. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave, and 10 weeks of gender-independent partnership leave. Our employees also benefit from multiple services on site such as childcare facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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