Gcp Compliance

vor 6 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**

As part of the RDMA (Research & Development/Medical Affairs) Opereational Excellence team, the GCP Compliance function is now expanding and is looking for a GCP Compliance & Training Manager responsible for the development of learning solutions improving inspection readiness and mitigate risks through relevant continuous learning experiences.

**Key Responsibilities**
- Using expertise in current and upcoming GCP requirements and internal procedures, create learner-centric and inspection readiness focused training strategies and programmes in alignment with the RDMA strategy and objectives
- Develop and leverage internal partnerships to ensure cross-functional content of the learning strategy and to continuously evaluate knowledge level in organisation with respect to e.g. external GCP regulations and internal clinical processes in order to plan and prioritise training activities including format, audience etc
- Provide training to relevant staff in e.g. new and updated regulations, SOPs, GCP issue management and CAPA development as applicable
- Respond to questions and ensure transfer of knowledge, e.g. by lessons learned between projects and studies

**Qualifications**
- University degree in Life Sciences or related discipline with at least 10 years’ experience from the pharmaceutical industry with GCP responsibilities
- Experience from planning and conducting training activities related to GCP area
- Experience of working cross-functionally and creating alignment across multiple functional areas
- Full understanding of the overall clinical development process from an international HQ perspective
- Experience from working with GCP related questions in a context where clinical activities are outsourced to a CRO
- Excellent pedagogical skills and written and oral communication abilities (English)

**Personal attributes**
- Interpersonal skills with communicative and flexible attitude - Structured and detail oriented - Individual initiative, prioritization and organization skills and multi-tasking abilities - Ability to work independently and to be part of a team - Individual initiative with a pro-active approach 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 Basel, Switzerland.

**Reporting to**

Head RDMA Operational Excellence

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 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**

xD5xb07PGR

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