Product Quality Lead

vor 6 Monaten

Basel, Schweiz Sobi Vollzeit

**Company Description** At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.**

The Product Quality Lead provides cross-functional quality leadership and supports program deliverables for assigned products and associated on-going life-cycle management activities including product transition from clinical to commercial, new product introductions and technology transfers across the network. The PQL is acting as main point of contact for providing assessment, guidance, and/or requirements relating to product quality aspects to cross-functional teams supporting the product lifecycle. The PQL is the quality representative of the development strategy of the product, ensuring global supply of IMPs and commercial products.

**Key Responsibilities**:

- Ensure end-to-end compliance for product manufacturing and life cycle management
- Implement and maintain Quality Risk Assessment and KPIs
- Lead complex change cases and coordinate product QA activities across markets
- Provide guidance on product quality aspects and support site transfers
- Participate in audits and inspections, and lead Product Governance boards
- Design SOPs, contribute to operational development, and lead Quality aspect of Due Diligence processes

**Qualifications** About you**:
All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

To be successful in this role you are a leader with the ability to manage challenging decisions in a logical and compliance manner, are comfortable in a global and complex environment with a Holistic business understanding. You have the skills to influence external Suppliers but also internally in a cross-functional environment to foster decisions and to propose solutions
- Hold a high-level education in pharmaceutical, biotech, or life sciences
- Possess at least 10 years of experience in pharmaceutical and biotech products
- Strong leadership skills with a proven track record with health authorities
- Deep understanding of GMP & GDP requirements and strategic planning
- Fluent in English with excellent communication and interpersonal skills

**Additional Information** Why Join Us?**

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

We are a global company with over 1,700 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you.

We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff.

**Sobi Culture**

At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases and have used this knowledge to shape our business to find new ways of helping them.

As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth.

  • Associate Director, Product Quality Lead, Quality

    vor 3 Monaten

    Basel, Schweiz Moderna Vollzeit

    The Role Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners worldwide,...

  • Product Quality Expert

    vor 6 Monaten

    Basel, Schweiz Takeda Pharmaceutical Vollzeit

    **About the role**: As Product Quality Expert (PQE) you will report directly to the Head of Quality Compliance & Systems and be responsible for compliance/regulatory activities related to biologic products. The PQE is the representative for different responsibilities, including: Regulatory Compliance activities, Interaction with Authorities, External...

  • Lead Quality Assurance Operations Scientist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a highly skilled Lead Quality Assurance Operations Scientist to join our team at Gi Group SA. This is a key role in ensuring the quality and compliance of our products.

  • Technical Project Lead

    vor 6 Monaten

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project & Product Lead - Drug Product (Parenteral/Combination Product) - 5759 ADA** Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, committed into delivering products on the market over the next 5 years, is looking for a **Technical Project & Product Lead - Drug...

  • Quality Manager Combination Products

    vor 6 Monaten

    Basel, Schweiz Skillhubs Vollzeit

    Our client is looking for a **Quality Manager**. **The role** In this pivotal role, you will be responsible for providing compliance oversight associated with **medical devices** and **combination product **development and manufacturing processes internally or at contract manufacturing organizations (CMOs). Performs quality assurance responsibilities for...

  • Senior Quality Assurance and Product Compliance Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Randstad - Medium prio Vollzeit

    Job SummaryWe are seeking an experienced Senior Quality Assurance and Product Compliance Manager to oversee the quality assurance and control for our hardware and software products.The ideal candidate will be responsible for ensuring compliance with European and international standards, managing quality processes across the product lifecycle, and leading a...

  • Chief Product Quality Officer

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Randstad - Medium prio Vollzeit

    Job DescriptionWe are seeking a highly experienced Chief Product Quality Officer to oversee the quality assurance and control for hardware and software products at Randstad.The ideal candidate will be responsible for ensuring compliance with European and international standards, managing quality processes across the product lifecycle, and leading a...

  • ERP Program Quality

    Vor 7 Tagen

    Basel, Schweiz F. Hoffmann-La Roche AG Vollzeit

    ERP Program Quality & Compliance Quality Lead (m/f/d)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...

  • Technical Project Leader Drug Product- Parenteral

    vor 6 Monaten

    Basel, Schweiz ALTOGEN AG Vollzeit

    **ALTOGEN** is a Swiss engineering and consulting company specialized in life sciences with proven expertise in pharmaceuticals, biotechnology, medical devices. With several years of experience, technical expertise and project coordination, we support our partners throughout all areas of the product life cycles. We surround ourselves with junior to expert...

  • Product Quality Manager

    vor 6 Monaten

    Basel, Schweiz Lionstep AG Vollzeit

    On behalf of **EM Microelectronic-Marin SA**, we are searching for their next **Product Quality Manager (f/m/d)**. **Job Summary** Are you on the lookout for an exciting opportunity as a Product Quality Manager and Core Tool Champion (f/m/d) where you can make a high impact, and unlock personal and professional growth? Then keep on reading! We have...

  • ERP Program Quality

    Vor 7 Tagen

    Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    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,...

  • ERP Program Quality

    Vor 3 Tagen

    Basel, Schweiz F. Hoffmann-La Roche Gruppe Vollzeit

    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,...

  • ERP Program Quality

    vor 8 Stunden

    Basel, Schweiz Roche Vollzeit

    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,...

  • Product Quality Manager

    vor 6 Monaten

    Basel, Schweiz EM Microelectronic-Marin SA Vollzeit

    **We work directly on behalf of EM Microelectronic-Marin SA and do not charge any agency fees.** **What this position has to offer**: - High impact role with significant visibility and challenges - Opportunity to create and empower the organization with automotive expertise - Personal and professional growth opportunities - Collaborative and innovative...

  • Drug Product Project Leader

    vor 6 Monaten

    Basel, Schweiz Novartis Vollzeit

    389788BR **Drug Product Project Leader (Oligonucleotides) (M/F/d)**: Switzerland **About the role** Location: Basel, Switzerland Join us in a cutting-edge role as a Drug Product Project Leader (DPPL) for Oligonucleotides, where you will have the opportunity to work on innovative parenteral formulations and contribute to the development of patient-centric...

  • Sterile Products Quality Assurance Specialist

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking an experienced Sterile Products Quality Assurance Specialist to join our team in Basel, Switzerland. The successful candidate will be responsible for supporting the implementation of Annex 1 requirements at our Clinical Supply Centre.As a member of our Quality Assurance team, you will collaborate with cross-functional teams to...

  • Senior Quality Assurance Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    Company Overview\Roche, a global leader in pharmaceuticals and diagnostics, is seeking an experienced Quality Assurance professional to join our team. We are committed to delivering high-quality products that improve people's lives.

  • Lead Pharmaceutical Development Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Company OverviewLonza, a leading global player in the life sciences industry, is expanding its capabilities in commercial drug product manufacturing. This growth presents an exciting opportunity for a seasoned leader to join our team and drive process development for late-stage commercial products.Job SummaryWe are seeking an experienced Lead Pharmaceutical...

  • Sr. Global Product Marketing Lead

    vor 6 Monaten

    Basel, Schweiz Straumann Group Vollzeit

    **About Straumann** The Straumann Group unites global reach, experience and innovation with passion and a commitment for uncompromising quality, making enhanced dental healthcare available and accessible to customers and patients around the globe. The group unites global and international brands that stand for excellence, innovation and quality, including...

  • Project Lead Clinical Quality Control Physico Chemical Analytics

    vor 4 Wochen

    Basel, Schweiz Lonza Biologics Porriño SLU Vollzeit

    Project Lead Clinical Quality Control Physico Chemical Analytics (m/f/d)Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange,...