Head of Quality Assurance
vor 1 Woche
**Head of Quality Assurance (M/F/d)**
Festanstellung, Vollzeit - Planegg-Martinsried
**Your mission**
**Your tasks and responsibilities**
- Lead the further implementation activities towards a comprehensive quality management system (QMS) covering all GxP areas, including the transition to an electronic QMS solution
- Drive and lead inspection activities according to global regulatory requirements (e.g. FDA, EMA, etc.)
- Develop risk-based approaches to quality management in clinical development
- Collaborate with C-level to align quality initiatives with business objectives
- Provide strategic direction for Quality Assurance in clinical trials and pharmacovigilance activities
- Oversee the planning and execution of internal and external audits across all GxP areas
- Manage relationships with regulatory agencies and represent the company in quality-related matters
- Drive the initiatives of quality technology solutions to enhance efficiency and compliance
**Your profile**
- Advanced degree in life sciences or related field with 15+ years of experience in pharmaceutical/biotech quality assurance, including significant experience in GCP and GVP
- Several years of experience in clinical studies according to ICH-GCP
- Experience in preparing for and managing regulatory inspections
- Proven track record in quality leadership roles within clinical development
- Comprehensive knowledge of global GxP regulations, with main expertise in GCP and GVP
- Strong leadership skills with the ability to influence at all levels of the organization
- Excellent analytical and problem-solving skills
- Fluent in English with excellent oral and written skills; good level of German.
**Why us?**
- Working in an innovative and dynamic environment and being part of a thriving biotech company
- Great working atmosphere within a highly motivated and multicultural team
- Creative working in X-functional teams
- Short communication channels
- Flexible working hours, office and home office based, enable time management on your own terms
- permanent contract
Auf diese Stelle bewerben
**About us**
CatalYm is a biotech company based in Martinsried near Munich, developing innovative immunotherapies to transform cancer patients’ lives by effectively engaging their own immune systems to combat this malignant disease. We are now advancing to Phase 2b studies to confirm visugromab, our lead antibody, that has demonstrated durable anti-tumor efficacy with long-lasting objective responses in relapsed and refractory metastatic solid tumor patients in combination with anti-PD-1 treatment. Our mission is to rapidly bring our next-generation immuno-oncology products to patients in need. Are you ready to board the fast-accelerating visugromab train in Martinsried? Then join us
-
Lead Quality Assurance Strategist
vor 2 Wochen
Planegg, Bayern, Deutschland WuXi AppTec VollzeitAbout the RoleWe are seeking a seasoned quality assurance professional to lead our team at WuXi AppTec in Munich, Germany. As a Lead Quality Assurance Strategist, you will be responsible for ensuring the highest standards of quality and compliance in our operations.Salary: €120,000 - €180,000 per yearAbout YouYou have a PhD/Master's degree in...
-
(Senior) Director of Quality Assurance
vor 6 Monaten
Planegg, Deutschland WuXi AppTec VollzeitOverview (Senior) Director of Quality Assurance (STA Qualified Person (QP)) Location: Germany, Munich, but willingness to travel and stay at WuXi STA Couvet, Switzerland site. Responsibilities Coordinate WuXi STA’s QP organization based in Germany Set up WuXi STA’s QP office and hold ownership of the related systems and processes. ...
-
Head of Quality
vor 5 Monaten
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Your mission**: At Planet A Foods, we are revolutionizing the food industry to protect the planet we love. by perfecting centuries-old fermentation technology, we offer healthier alternatives and can save up to 500 Mt of CO2 per year! We created the world’s first 100% cocoa-free chocolate called ChoViva. Our ChoViva tastes amazing with a solid snap and...
-
Quality Assurance Internship
vor 5 Monaten
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Your mission**: At Planet A Foods, we want to revolutionize the food industry to protect the planet we love. We believe that creating better food ingredients, done by perfecting centuries-old fermentation technology, leads to healthier alternatives for us all and can save up to 500 Mt of CO2 per year. Our first product? Yummy chocolate! We created the...
-
Head of Procurement
vor 2 Monaten
Planegg, Deutschland Planet A Foods GmbH VollzeitDo you want to make a delicious difference?As a fast-growing, mission-driven startup committed to revolutionise the food industry, we're assembling a dynamic A-Team! As our Head of Global Procurement, you'll develop and implement sourcing strategies for high-quality ingredients, manage supplier relationships, optimise the supply chain, and ensure compliance...
-
Head of Procurement
vor 3 Monaten
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Your mission**: At Planet A Foods, we are revolutionizing the food industry to protect the planet we love. by perfecting centuries-old fermentation technology, we offer healthier alternatives and can save up to 500 Mt of CO2 per year! We created the world’s first 100% cocoa-free chocolate called ChoViva. Our ChoViva tastes amazing with a solid snap and...
-
Head of People
vor 5 Monaten
Planegg, Deutschland Planet A Foods GmbH Vollzeit**Your mission**: Are you passionate about leading a dynamic team and fostering an extraordinary company culture? Join Planet A Foods as our **Head of People & Culture**! Our mission is to revolutionize the food industry and protect the planet we love! We believe perfecting centuries-old fermentation technology leads to healthier food alternatives and can...
-
Head of Supply Chain Strategy
Vor 3 Tagen
Planegg, Bayern, Deutschland ResMed VollzeitOverview">ResMed is a pioneering medical technology company dedicated to improving the lives of millions of people worldwide. We are seeking an experienced Head of Supply Chain Strategy to join our Global Planning and Logistics team in Europe or the UK.">Salary:">We offer a competitive salary of €120,000 - €150,000 per annum, depending on...
-
Head of Paid Media
vor 6 Monaten
Planegg, Deutschland plaion VollzeitPLAION - MunichPLAION (formerly known as Koch Media) is an international media company with more than 2000 employees worldwide. As a leading and independent producer and marketer of digital entertainment products in Europe, the USA, Australia and Japan, our business areas include the production of films and games, the purchase and sale of film license...
-
Technical Assistant Quality Control
vor 2 Monaten
Planegg, Deutschland Ascend Advanced Therapies VollzeitWe are looking for a **Technical Assistant Quality Control - Cell Biology QC and R&D** to join our dynamic team. If you’re passionate about making a difference and working in an industry without limits, this is your opportunity. ***About Ascend**: Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is...
-
Chief Procurement Strategist
vor 3 Wochen
Planegg, Bayern, Deutschland Planet A Foods GmbH VollzeitAbout the RoleWe are seeking a highly experienced Chief Procurement Strategist to join our dynamic team at Planet A Foods GmbH in Planegg, Germany. As a key member of our Operations Department, you will be responsible for developing and implementing strategic sourcing plans to ensure the quality and cost-effectiveness of our ingredients.Job...
-
Head of Paid Media
vor 6 Monaten
Planegg, Deutschland Koch Media VollzeitYour Profile 7+ years’ experience managing paid media campaigns Experience in leading and empowering a team Experience across the breadth of social media and other marketing channels: Facebook, Twitter, TikTok, Snapchat, Paid Search, Programmatic and Display A university degree in Business Administration (or comparable) with a focus on Marketing...
-
Technical Assistant Quality Control
vor 2 Monaten
Planegg, Deutschland Ascend Advanced Therapies VollzeitWe are looking for a Technical Assistant Quality Control - Cell Biology QC and R&D to join our dynamic team. If you’re passionate about making a difference and working in an industry without limits, this is your opportunity. About Ascend: Ascend is pioneering the future of healthcare through relentless innovation, our forward-thinking company is on a...
-
(Senior) C++ Developer
vor 2 Monaten
Planegg, Deutschland epay, a Euronet Worldwide Company VollzeitWe are epay. As an independent full-service payment provider, we offer a single-interface platform that enables maximum flexibility in the everchanging payment journey. Our distribution network is one of the fastest growing networks with hundreds of innovative partners in multiple countries. This way we connect retailers, brands, and consumers with scalable...
-
Strategic Buyer
vor 2 Monaten
Planegg, Deutschland Planet A Foods GmbH VollzeitDo you want to make a delicious difference?As a fast-growing, mission-driven startup committed to revolutionise the food industry, we're assembling a dynamic A-Team! As our Strategic Buyer, you'll develop sourcing strategies for high-quality ingredients, manage supplier relationships, optimise the supply chain, and ensure compliance with food safety...
-
Director Cmc
vor 6 Monaten
Planegg, Deutschland Ethris GmbH Vollzeit**Our mission**: At Ethris, we are working at the forefront of medical innovation and technology. To us, this is a once-in-a-lifetime chance, working on rethinking human therapeutics. We strive towards developing the next generation of mRNA therapeutics and vaccines for respiratory diseases. We're a dedicated and skilled team of around 70 with different...
-
Director Cmc
vor 6 Monaten
Planegg, Deutschland Ethris GmbH VollzeitOur mission At Ethris, we are working at the forefront of medical innovation and technology. To us, this is a once-in-a-lifetime chance, working on rethinking human therapeutics. We strive towards developing the next generation of mRNA therapeutics and vaccines for respiratory diseases. We're a dedicated and skilled team of around 70 with different cultural...
-
Nucleic Acid Chemist
vor 5 Monaten
Planegg, Deutschland metabion GmbH Vollzeit**Responsibilities**: - Phosphoramidite based chemical synthesis of modified and unmodified oligonucleotides using automated mid-/large scale solid phase synthesis technologies. - Hands-on experience in operating automated oligonucleotide synthesis platforms. - Purification and evaluation of purity and structural integrity of synthesized oligonucleotides. -...
-
Lager- Und Versandmitarbeiter
vor 6 Monaten
Planegg, Deutschland metabion GmbH VollzeitAufgaben: - Annahme, Auspacken, Kontrolle und Verbuchung von Warenlieferungen gemäß den Vorgaben. - Innerbetrieblicher Transport und Bereitstellung von Waren. - Dokumentation von Fehlbeständen. - Vollständige Dokumentation der durchgeführten Tätigkeiten mithilfe des Warenwirtschaftssystems. - Durchführung von Inventuren. - Verpacken und...
-
Financial Accountant
vor 3 Monaten
Planegg, Deutschland Ascend Advanced Therapies VollzeitJoin our dynamic finance team as a key contributor, supporting the Finance Manager in a hands-on role that directly impacts our financial success. You will be instrumental in supporting the month-end process, the preparation of the consolidated management accounts and in the management of the whole AP cycle. Your keen eye for detail will help identify trends...