Job Description

The Position

The Position

The role of Pharma IT Quality Assurance is a trusted partner for customers to ensure and improve the overall quality of IT systems throughout their lifecycle with a focus on compliance with regulatory, legal and finance requirements. We are looking for a customer-focused, highly collaborative individual to work with delivery units to advance existing emerging business critical technology according to Roche Pharma needs. The selected candidate will be responsible to:

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 providing recommendations for new guidance/standards or revisions to existing guidance/standards.

Provide consultation and guidance to delivery and operational units within Pharma IT on accurate interpretation of Roche CSV approach and requirements

Provide independent quality support / quality oversight to IT projects or to IT programs (Application or Infrastructure)

Provide Business Quality oversight for IT4IT systems with regard to Computer Systems Validation

Gather and analyze metrics and key performance indicators to identify opportunities for process improvement

Escalate non-compliance against quality standards to appropriate governance bodies and Risk Management function for resolution

Facilitate and leverage quality practitioners within the delivery units to identify best practices, and lead improvement initiatives across functional areas

Who you are

You\xe2\x80\x99re someone who wants to influence your own development. You\xe2\x80\x99re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

Where a job title is not considered the final definition of who you are, but the starting point.

You have the following qualifications:

B.A. or B.S. degree with at least 5-10 years of experience IT Quality Assurance or equivalent combination of education and experience

Working knowledge of Pharmaceutical Regulations (US, EU, other regulators) as it relates to Computer Systems Validation

Experience with resolving compliance issues for both infrastructure elements as well as end user applications layers.

Ability to work remotely in teams.

Strong interpersonal skills when interacting with personnel at all levels.

Ability to teach and train on IT Quality processes.

Proven ability to make sound decisions and flexibility in problem solving.

Must be able to maintain flexible working hours to interact with ITQuality team members and customers in different time zones.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we\xe2\x80\x99ve become one of the world\xe2\x80\x99s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

The Roche Services & Solutions as well as People Support Solutions organisations located in Kuala Lumpur provide end-to-end business solutions for Finance, Procurement, IT, Communications, People & Culture (Human Resources) and beyond to our Roche colleagues across the APAC region. Today Roche employs altogether around 1100 employees in Malaysia.

Roche is an Equal Opportunity Employer.

Roche