Head of Global Gxp Compliance

vor 6 Monaten

Basel, Schweiz Sobi Vollzeit

**Company Description**
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.

Are you a seasoned professional with extensive experience in the pharmaceutical industry and great competence in GxP quality and compliance? Sobi is seeking a dynamic individual to lead our Global GxP Compliance & Quality Systems department within the Global Quality team.

This is an opportunity to lead a global team and contribute to the development of competitive products in a growing company, by engaging in strategic decision-making processes and quality management.

**Key Responsibilities**
- Lead the design and implementation of a proactive Quality organization to ensure compliance and reliable product supply and development.
- Develop and maintain an adaptable Quality management System to meet Sobi´s growth journey in accordance with regulatory guidelines and Sobi global processes
- Responsible for governance and development of GxP/MDR processes
- Drive digitalization and development of eQMS systems for a virtual setup. Responsible for eQMS modules in Veeva
- Management ofaudits within GMP, GDP.
- Monitor regulatory requirements for GxP/MDR.
- Responsible for quality KPI reporting
- Build competencies for due diligence activities.

**Qualifications**
- Minimum 15 years of experience in the pharmaceutical industry, focusing on global Quality systems, manufacturing, product development, and regulatory affairs
- Minimum 10 years of leadership experience in a global environment
- Experience in managing Quality Management Systems within the pharmaceutical industry.
- Strong knowledge of cGxP (GMP, GDP, GVP, GCP) with focus on GMP/GDP, MDR, and regulatory requirements.
- Leadership skills to manage a team and drive efficiency improvements.
- Excellent communication and collaboration abilities with stakeholders.
- Holistic business understanding
- Courageous, empathetic, and trustworthy

**Additional Information**
In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease.

**Why Join Us?**

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.

**An Equal Opportunity Employer

  • Gxp E-compliance Manager

    Vor 3 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Company Description** **_ At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always...

  • Gxp E-compliance Manager

    Vor 3 Tagen

    Basel, Schweiz Sobi Vollzeit

    Full-time Sobi Location: Switzerland **Company Description**: At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients,...

  • Compliance Support Gxp Training

    vor 6 Monaten

    Basel, Schweiz Actalent Vollzeit

    Tasks & Responsibilities: - Administrative support of training measures resulting from local and global requirements as well as participation in the implementation of the required training concepts. - Development of training materials and cooperation in the organization of training courses. - Support of the customer departments in the implementation of the...

  • Quality Engineer and GxP e-Compliance Specialist

    vor 3 Wochen

    Basel, Schweiz Sobi Vollzeit

    Job DescriptionAs the Quality Engineer and GxP e-Compliance Specialist you will play a pivotal role in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle management and quality data stewardship. This role will support the company's vision of "Ensure eCompliance and Goes digital to enable Quality decisions driven...

  • Global Head of Quality Operations

    vor 3 Wochen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    Quality Operations LeadLonza is a global leader in life sciences operating across three continents. Our approach to quality is rooted in the belief that talented people working together can devise ideas that help businesses improve lives. To achieve this, we empower our teams to own their careers and drive innovation. We are seeking a Global Head of Quality...

  • Head of Legal

    vor 7 Monaten

    Basel, Schweiz Humentum AG Vollzeit

    For our customer, a global acting supplier of high-performance industrial components and engineered solutions, who is expanding its business areas both horizontally and vertically and its business volume is increasing worldwide, we seek you as: **Head of Legal & Compliance** Job-ID 67281 As the Head of Legal and Compliance you will be part of the Group...

  • Team Lead

    vor 6 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    Team Leader - GxP Audit We are seeking a qualified Lead Auditor to play a pivotal role in our GxP (Good Clinical, Laboratory, Manufacturing, Pharmacovigilance, and Distribution Practices) Audit Team. As the Lead Auditor, you will be responsible for the planning and execution of audits to evaluate GxP compliance, including GCLP, GCP, GDP, GMP, and GVP, in...

  • Global Head of Pricing

    vor 2 Monaten

    Basel, Schweiz Abbott Vollzeit

    OBJECTIVES/PURPOSE:The Global Head of Pricing is a pivotal role that develops and executes Abbott’s global pricing strategy, guidance, governance and processes to fulfill our purpose Life. To The Fullest. The Head of Pricing will partner with the respective regional access teams, Global Access team, Policy, Government Affairs, Finance and HEOR to...

  • Global Head of Tender Management

    vor 7 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    **Abbott** is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160...

  • Executive Director, Global Head of Quality Operations

    vor 5 Monaten

    Basel, Schweiz Lonza Vollzeit

    Today, Lonza is a global leader in life sciences operating across three 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, we let our people own their careers. Their ideas, big and small,...

  • Head of Legal

    vor 6 Monaten

    Basel, Schweiz Myovant Sciences GmbH Vollzeit

    Myovant Sciences GmbH is a Sumitomo Pharma company and an affiliate of Sumitomo Pharma America (SMPA). We are part of an ecosystem that tackles unmet patient needs in the crucial fields of psychiatry and neurology, oncology, urology, women's health, rare diseases, and cell and gene therapies. Our diverse portfolio includes several marketed products and a...

  • Global Head of Quality Strategy, Consumer Health

    vor 6 Monaten

    Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Global Quality Country Organization Head

    vor 3 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Company Description** **_ At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients, moving quickly and always...

  • Global Quality Country Organization Head

    vor 1 Woche

    Basel, Schweiz Sobi Vollzeit

    Full-time Sobi Location: Switzerland **Company Description**: At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients,...

  • Global Quality Country Organization Head

    Vor 2 Tagen

    Basel, Schweiz Sobi Vollzeit

    Full-time Sobi Location: Switzerland **Company Description**: At Sobi, the work we do every day redefines the standards of care and transform the lives of people living with rare diseases. As a diverse team of entrepreneurial people, we are passionate about our growth journey towards becoming a global leader, making a difference for rare disease patients,...

  • Global Head of Pricing

    vor 2 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    **_OBJECTIVES/PURPOSE:_** The **Global Head of Pricing** is a pivotal role that develops and executes Abbott’s global pricing strategy, guidance, governance and processes to fulfill our purpose Life. To The Fullest. The Head of Pricing will partner with the respective regional access teams, Global Access team, Policy, Government Affairs, Finance and HEOR...

  • Copy of Head of Global QA External Operations

    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.** Here at Sobi, our mission and culture get us...

  • Global Head of Tender Management

    vor 2 Monaten

    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Abbott...

  • Global Head of Tender Management

    vor 7 Monaten

    Basel, Schweiz Abbott Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. Abbott...

  • Global Head of Tender Management Lead

    vor 2 Monaten

    Basel, Basel-Stadt, Schweiz Abbott Vollzeit

    Job SummaryAbbott is a leading global healthcare company that seeks a talented professional to fill the role of Global Head of Tender Management. As a key member of our team, you will play a crucial role in optimizing tender readiness and improving our win/loss ratio. Your primary responsibility will be to lead the development of our global brand value...