QA Computer Compliance Manager

**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.**

**QA Computer Compliance Manager**:
**Role & Function**
The position is situated in our Quality function in Switzerland, where you will be part of a team consisting of highly professional people, who work hard and have fun on the way. Sobi has embarked on a journey to become a Global Leader within Rare diseases. Digital solutions are an integral and important building block in this journey. As QA Specialist your goal is to deliver support and advice regarding GxP regulated computerized systems. You will have a role interfacing with all parts of the Sobi organization.

**Key Responsibilities**
- QA support to line of business for computerized systems with focus on manufacturing and laboratory systems) e.g. review and approve quality related documentations such as SOP’s, specifications, validation/qualification documents, periodic reviews, change requests, CAPAs, deviations etc.- QA Project Support involving computerized systems, data transfer, IT related topics.- Drive and take responsibility for improvement projects as applicable.- Contributing to the ongoing maintenance and optimizing the routines for computerized system e.g. updating templates, system list, VMP and follow up the periodic review of the systems.- Contributing to the ongoing maintenance and optimizing of Sobi´s Quality System.- Support authority inspections and partner audits from computer compliance point of view.- Lead or participation in external audits of suppliers and supplier evaluations could be included in the responsibilities depending on your background and ambition.- Additionally, you will participate in various projects across the entire organization and with many different stakeholders.**Qualifications**
- Probably you hold an Engineering or a Master´s degree in IT or Life science combined with some years of experience working in a Quality role in a GxP regulated environment (e.g. CFR Part 11, EU GMP VOLUME 4 (Annex 11)).- Preferably you have a background working in a similar role as QA for computerized systems or from being validation/system responsible, you can also work in a quality role within IS/IT.- The position is also open for applicants with a background as QA from the pharma/medical device industry and the motivation to further develop their skills within QA for computerized systems.- Professional level of English is a must.- Data Integrity and GAMP is a plus.- Auditor training and/or knowledge of supplier management is also a plus but is not required.**Personal attributes**
As a person you can work independently and have an ambitious mindset. You are proactive, service minded and a profound team player. Furthermore, you possess excellent communication 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 Basel, Switzerland.

**Reporting to**
Head of GxP Process Excellence Head.

**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.