Quality Assurance Specialist
3 tygodni temu
Job Overview
We are seeking a highly skilled Quality Assurance Specialist to join our team at Roche. The ideal candidate will have a passion for quality and a proven track record of ensuring regulatory compliance.
Key Responsibilities
The successful candidate will be responsible for ensuring that Roche’s regulated systems and services adhere to regulatory standards such as CSV, GMP, and GCP. They will also be responsible for managing regulatory risks and providing consultation and guidance to delivery and operational units across Informatics.
- Participate in the development of new standards and revision of existing standards related to Computer Systems Validation (CSV)
- Assemble global feedback on proposed or existing standards and tools and provide recommendations for new guidance/standards or revisions to existing guidance/standards.
- Provide consultation and guidance to delivery and operational units across Informatics on accurate interpretation of Roche CSV approach and requirements
- Provide independent Quality Assurance oversight/support for IT4IT systems (and some business domains) with regard to Computer Systems Validation and other regulatory systems.
- Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management functions for resolution
- Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas
What You’ll Need to Succeed
- Exhibits servant and creative leadership (VACC) behavior
- Exhibits a Lean-Agile Mindset and excels at Product Management practices
- Takes “progressive risk”--not thrill-seeking, but risk that leads to opportunity
- Has a keen Quality & Regulatory focus: You are passionate about major trends
- Demonstrates an executive presence, strong business acumen, ability to navigate ambiguity, and manages complexity
- Has an enterprise mindset that can break down silos. Focus on continuous delivery through collaboration, and bringing people together to work towards the same purpose across organizational boundaries.
- Exhibits ability to empower teams and individuals to act autonomously and hold them accountable
- Exhibits intellectual curiosity and integrity and has a strong passion for innovation
- Understanding of health regulatory frameworks (FDA, GxP)
- Understanding of risk and control frameworks and quality standards including government guidelines and laws (HIPAA, GDPR)
- Experience with control automation
What We Offer
- Salary range 21 000 - 26 000 PLN grossbased on the employment contract (Umowa o pracę),
- Annual bonus payment based on your performance;
- Dedicated training budget (training, certifications, conferences, diversified career paths etc.);
- Highly flexible working arrangements - you have an impact on your daily schedule and you will work with your manager on how often you visit our office
- Recharge Fridays (2 Fridays off per quarter available)
- Take time Program (up to 3 months of leave to use for any purpose)
- Flex Location (possibility to perform our work from different places in the world for a certain period of time)
- Take Time for Charity (additional paid leave of maximum 2 weeks to engage in the charity action of your choice)
- Private healthcare (Medicover packages) and group life insurance (UNUM);
- Stock share purchase additions;
- Yearly sales of company laptops and cars and many more
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