IT Integration Project Manager - QA focus
IT Integration Project Manager - QA focus
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
We are seeking a highly skilled Project Manager (PM) to join our IT Integration Project team focusing on Validated Systems including Global and Local Quality and Lab (GxP) applications and systems.
The ideal candidate will have extensive experience in GxPregulated environments and laboratory applications ensuring seamless system integration and compliance.
This role is hybrid and requires the PM to be based on the US West Coast with onsite presence every two weeks.
Key Responsibilities:
- Define the size cost and duration of integrating six global and 30 local applications.
- Identify key requirements and risks for the validated systems integration.
- Confirm system process and data owners for each validated application.
- Engage with local site teams to drive the transition of local lab applications to local ownership.
- Oversee domain changes for the 30 local applications ensuring alignment
- Drive the validation documentation updates postintegration.
Requirements
- Strong Project Management experience in IT integration projects.
- GxP & Laboratory Systems expertise (quality compliance and validation in a regulated environment).
- Experience with global and local application ownership transitions in a pharmaceutical or biotech setting.
- Ability to work crossfunctionally with IT manufacturing quality and regulatory teams.
- Strong understanding of validation processes and compliance documentation.
- Excellent communication and stakeholder management skills.
- Must be based on the US West Coast and able to be onsite every two weeks.
- Fluency in English.
Fluent in written and spoken English Master's degree in computer science Several years of experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL) In-depth knowledge of the regulatory environment (e.g. GxP, audits) and information technology In-depth knowledge of GxP-relevant IT processes and their support by computerized systems Excellent communication skills, analytical thinking and the ability to work in a spirit of partnership Ability to build consensus and influence decisions
Employment Type
Full Time
