Gxp Audit Team Lead

vor 5 Monaten

Basel, Schweiz Sobi Vollzeit

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.

**Role & Function**

The GxP Audit Team Lead supports the organization through the strategic planning and execution of audits to assess compliance with GxP (GCLP, GCP, GDP, GMP, GVP, including CSV requirements). Ensured by: - Consistent implementation of processes and procedures in the delivery of the audit program and execution of the audit strategy. - Principal lead to developing and execution of the Inspection Management Strategy for the Sobi organization.

**Key Responsibilities**
- Responsible for the GxP Annual Audit Plan working in conjunction with the GxP Quality SMEs.
- Responsible for the execution of Audits according to the Audit Program
- Ensure audits are resourced, conducted, and reported in accordance with applicable SOPs, department manuals, and the annual audit program
- Responsible for reviewing audit deliverables such as draft audit plans and draft audit reports
- Responsible for ensuring timely closure of audits and appropriate CAPA plan review and approval
- Escalate compliance issues/risks to Senior Management as appropriate
- Responsible for the development and execution of Sobi Inspection Management Strategy working in conjunction with other Quality functional heads
- Support the preparation for and hosting of regulatory authority inspections
- Responsible to provide regular key learning and strategic insight from internal and external audits and audit related processes
- Maintain knowledge of company policies, SOPs, and supporting documents related to drug development/manufacturing/distribution as well as FDA and EU regulations and ICH guidance documents (as applicable) along with any other national or international regulations
- Perform Audits as Lead Auditor as needed
- Lead the QA Auditor Team

**Qualifications**
- University degree in Life Sciences or related discipline.
- At least 15 years’ experience from the pharmaceutical industry with GXP responsibilities.
- Experience of working with GXP audits/inspections
- Excellent knowhow of the EU/US/RoW regulations within GMP/GDP/GLP/GCP /GVP
- Excellent verbal and written communication skillsDesired: Experience working as Inspector, or managing auditor teams

**Personal attributes**

In order to be successful in this position you should be able to live up to our core values:
Care, Ambition, Ownership, Urgency, and Partnership, in addition to:

- Delivery focused - Collaborative
- Structured and detail oriented
- Strong individual initiative with multi-tasking abilities
- Demonstrate a mature organizational/people skills In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

**Location**

The position will be based in Switzerland.

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

**Why Join Us?**

We are a global company with around 1,500 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 patie

  • Team Lead

    vor 5 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...

  • Sustainability Reporting Manager

    vor 1 Woche

    Basel, Schweiz Audit International Vollzeit

    **Job type**:Perm **Town/City**:Basel **Country**:Switzerland **Salary/Rate**:0 **Specialism**:Internal Audit **Seniority**:Manager **Job ref**:JMK79 **Post Date**:07.11.24 **About the Role**: **Responsibilities** - Manage non-financial annual reporting: Set reporting standards and requirements, lead cross-functional reporting team, ensure data...

  • Clinical Document Management: Migration Team Lead

    vor 5 Monaten

    Basel, Schweiz Novartis Vollzeit

    393659BR **Clinical Document Management: Migration Team Lead**: Switzerland **About the role** We are seeking a CDM Migration Team Lead to join our CDM team reimagining TMF at Novartis! This position is accountable for leading business activities relating to data migrations in and out of Novartis electronic Document Management Systems (eDMS), ensuring...

  • IT Business Solution Leader Manufacturing and PLM

    vor 1 Monat

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    About the RoleWe are seeking a seasoned IT Business Solution Leader to join our Manufacturing Operations team at Lonza. As a key member of our organization, you will be responsible for driving digital transformation and innovation in manufacturing, ensuring seamless technology integration and alignment with business strategy.Key ResponsibilitiesPartner with...

  • Head of Global Gxp Compliance

    vor 5 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...

  • Head of Global GxP Quality Management System

    vor 3 Monaten

    Basel, Schweiz Sobi group Vollzeit

    Head of Global GxP Quality Management SystemEmployment Type: Full-timeAt 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...

  • Gxp Training Manager

    vor 5 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    GxP Training Manager Du hast einen Background in der Pharmazie/Biotechnologie und schone erste Erfahrungen im GxP-Trainingsbereich? Unser Kunde in Basel, sucht Verstärkung für das Schulungssupport Team! Location: Basel Vertragsdauer: unbegrenzt **Ihre Aufgaben**: - Administrative Unterstützung von Schulungsmaßnahmen, die sich aus lokalen und...

  • Team Assistant

    vor 5 Monaten

    Basel, Schweiz KPMG Vollzeit

    **Team Assistant / Account Coordinator - Audit Corporates**: - Do you enjoy working in a team-oriented, globally diverse environment and are happy to be able to use your excellent communication and organizational skills daily? Are you innovative, ambitious, and client-oriented? - Then join our global audit team!- Basel - Immediately - 100 % **Your...

  • Team Assistant

    vor 5 Monaten

    Basel, Schweiz KPMG Vollzeit

    Team Assistant / Account Coordinator - Audit Corporates - Do you enjoy working in a team-oriented, globally diverse environment and are happy to be able to use your excellent communication and organizational skills daily? Are you innovative, ambitious, and client-oriented? - Then join our global audit team!**Basel** **Immediately** **100 %** Your...

  • Cleaning Validation Leader

    vor 5 Monaten

    Basel, Schweiz Novartis Vollzeit

    393612BR **Cleaning Validation Leader (M/F/d)**: Switzerland **About the role** Location: Basel, Switzerland Role Purpose: We are looking for a Cleaning Validation Leader to support the department Chemical & Analytical Development as part of the Global Technical R&D department of Global Drug Development. You will play a crucial role in establishing,...

  • Audit Manager

    vor 5 Monaten

    Basel, Schweiz Bank For International Settlements Vollzeit

    **Audit Manager** The Bank for International Settlements (BIS) is hiring an Audit Manager to join our Internal Audit team. **Purpose of the job**: Our mission is to support central banks' pursuit of monetary and financial stability through international cooperation, and to act as a bank for central banks. You will contribute to this mission by: -...

  • Head of Global GxP Quality Management System

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

  • Manufacturing and Product Life Cycle Leader

    Vor 5 Tagen

    Basel, Basel-Stadt, Schweiz Lonza Vollzeit

    We're looking for a seasoned IT professional to lead our manufacturing and product life cycle capabilities. As a Business Partner, you'll work closely with our global manufacturing organization to identify and deploy the right technologies to support our business strategy and growth.Key Responsibilities:Drive demand for new capabilities and technology across...

  • Global Pv Systems Lead

    vor 5 Monaten

    Basel, Schweiz Sobi Vollzeit

    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. **Role & Function** At Sobi,...

  • Regulatory Affairs Team Lead

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Straumann Group Vollzeit

    Job Title: Regulatory Affairs Team LeadAbout the Role:We are seeking a highly skilled Regulatory Affairs Team Lead to join our team at Straumann Group. The successful candidate will be responsible for ensuring that all products in scope are designed, manufactured, and distributed in accordance with applicable regulatory requirements.Main Responsibilities:*...

  • Quality Assurance Manager

    vor 4 Wochen

    Basel, Basel-Stadt, Schweiz Randstad Vollzeit

    Job DescriptionAs a Quality Assurance Manager, you will play a crucial role in ensuring the compliance of our client's pharmaceutical products with GxP regulations. You will be responsible for overseeing the Quality Management System, conducting audits, and providing quality advice to internal and external stakeholders.Key ResponsibilitiesSupport Quality...

  • Director, Internal Audit, Excellence

    vor 5 Monaten

    Basel, Schweiz Novartis Vollzeit

    393592BR **Director, Internal Audit, Excellence & Operations - Remediation**: Switzerland **About the role** FTE: 80 - 100% Location: Basel The Director, Internal Audit (IA), Excellence & Operations - Remediation will lead and manage the remediation process for identified high risks and mitigation areas, identified during audits on a global scale. Working...

  • Local Master Data Lead Warehouse

    vor 5 Monaten

    Basel, Schweiz Coopers Group AG Vollzeit

    Master Data Lead Warehouse Für unseren Kunden aus der Pharmazie Branche in Basel, suchen wir einen erfahrenen, motivierten und aufgeschlossenen **Master Data Lead Warehouse** **Hintergrund**: Die Rolle wird für die Überwachung und Organisation der Business-Aktivitäten sowie für die Leitung von Datenbereinigungszyklen und des Datenmigrationsprozesses...

  • Lead Master Data Management

    vor 5 Monaten

    Basel, Schweiz Work Selection Vollzeit

    **Beschreibung**: Willkommen zu einer spannenden Gelegenheit mit unserem internationalen Kunden. Wir suchen eine dynamische und hochmotivierte Person für die Position **Lead Master Data Management**: Als "Master Data Lead Warehouse" sind Sie für die Verwaltung und Führung des Datenmanagementprozesses im Zusammenhang mit einem internen Data Warehouse...

  • IT Internal Audit Manager

    vor 4 Wochen

    Basel, Schweiz Straumann Group Vollzeit

    Job Purpose As an IT Audit Manager, s/he will plan and lead engagements to evaluate IT processes and security controls based on frameworks and standards such as NIST and ISO 27001. S/he will perform IT compliance assessments based on industry standards and regulatory requirements. In this role, s/he will partner with IT management and technical leads in...