Product Quality Lead

vor 4 Wochen

Basel, Schweiz Sobi Vollzeit
Job Description

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.

 

  • Product Quality Lead

    vor 3 Wochen

    Basel, Schweiz Swedish Orphan Biovitrum Vollzeit

    **Product Quality Lead** Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere. The...

  • Product Quality Lead

    vor 4 Wochen

    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...

  • Product Quality Lead

    vor 4 Wochen

    Basel, Schweiz Sobi, Inc Vollzeit

    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.Job DescriptionThe Product Quality Lead provides cross-functional...

  • Product Quality Lead

    vor 1 Woche

    Basel, Basel-Stadt, 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...

  • Product Quality Lead

    vor 3 Wochen

    Basel, Schweiz Sobi, Inc Vollzeit

    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.Job DescriptionThe Product Quality Lead provides cross-functional...

  • Product Quality Lead

    vor 2 Monaten

    Basel, Schweiz Hobson Prior Vollzeit

    **Salary**: CHF150000 - CHF160000 per annum**Job type**: Permanent **Location**: Basel, Switzerland **Function**: Quality Assurance, Quality Systems **Posted**:28/07/2023 **Ref**: BBBH23232 - Hi I'm Jacob , I manage this role Hobson Prior are currently looking for a Product Quality Lead to join a brilliant pharmaceutical organisation on a permanent...

  • Product Quality Lead

    vor 2 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    Product Quality Lead For a fast-growing biotechnology firm that is focused on the development and production of innovative and life-changing products, we are seeking a highly skilled and motivated Product Quality Lead to join the team! As the Product Quality Lead, you will play a key role in ensuring the quality of our products from development to...

  • Product Quality Lead

    vor 3 Wochen

    Basel, Schweiz Coopers Group AG Vollzeit

    Product Quality Lead For a fast-growing biotechnology firm that is focused on the development and production of innovative and life-changing products, we are seeking a highly skilled and motivated Product Quality Lead to join the team! As the Product Quality Lead, you will play a key role in ensuring the quality of our products from development to...

  • Director, Product Quality Lead

    vor 4 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks....

  • Director, Product Quality Lead

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Moderna Therapeutics Vollzeit

    The Role:Reporting to the Sr Director, Global Quality Operations, the Director, Product Quality Lead will be responsible for providing quality oversight of drug products throughout the product and design control lifecycle. Develop, approve, monitor, and maintain critical quality standards to proactively minimize product quality and design control risks....

  • Associate Director, Product Quality Lead

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    The Role Critical Raw Material (CRM) play an essential role for our Product Quality impacting across all our programs. Reporting to the Sr Director - Product Quality, the A/Director - Product Quality Lead (PQL) will be responsible for providing end-to-end quality oversight to our critical raw material. Develop, approve, monitor, and maintain critical...

  • Product Quality Expert

    vor 3 Wochen

    Basel, Schweiz ARIAD Vollzeit

    At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a...

  • Product Quality Expert

    vor 3 Wochen

    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...

  • Product Quality Expert

    vor 1 Woche

    Basel, Basel-Stadt, 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 inspections...

  • Technical Project

    vor 3 Wochen

    Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **Technical Project & Product Lead - Drug Product (Oral Dosage) - 5752 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 Product (Oral...

  • Technical Project Lead

    vor 2 Wochen

    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 1 Woche

    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...

  • Technical Project Leader Drug Product

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

    Technical Project Leader - Drug Product (5175 ADA)Our client, an innovative and dynamic bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a Technical Project Leader Drug Product to join their late-stage development and commercial oral dosage forms and lead the drug product development of various oral...

  • Quality Control Lead Investigator

    vor 3 Wochen

    Basel, Schweiz Modis Vollzeit

    For a leader in the pharmaceutical industry, opportunity of minimum 15 months as Quality Control Lead Investigator. Your Role: - Act as Deviation Owner and Lead Investigator for QC deviations requiring a formal root cause analysis. - Enable and Support team of the Quality Control (QC) department responsible for testing raw materials, drug substance (API),...

  • Technical Project Leader Drug Product- Parenteral

    vor 3 Wochen

    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...