IT Director, R&D and Quality Systems
Salary: $190,000 - $220,000 + bonus
Glocomms are partnered with a bio-pharmaceutical company in the search for an IT Director to spearhead the R&D and Quality Systems function of the business. We are looking for an ideal candidate with strong experience building/managing R&D and Quality Systems roadmaps using Veeva core within the Pharmaceutical/Biotech/Life Sciences industry. You should also understand the development process for new drugs and clinical trials, as well as clinical and quality requirements. This role will focus heavily on program managements and business analysis - being able to understand business requirements and translating them into IT to ensure the delivery of new systems.
Please see responsibilities below:
- Lead and own architecture for R&D and Quality by formulating business strategy and developing/maintaining IT roadmap.
- Lead the IT validation workstreams for GxP system initiatives.
- Maintain project timeliness and respond to information requests for R&D and Quality functions.
- Provide technical strategy, solutions and leadership for the development of systems for the R&D and Quality department.
- Lead the governance forum for R&D/Quality to streamline the decision making process.
- Ensure project timelines are met, and respond to information requests for R&D and Quality functions.
- Policy, controls, and process development and implementation in accordance with regulatory requirements.
- Ensure that all GxP systems are in compliance with IT CSV SOPs.
Please see required experience below:
- Strong background in Pharmaceutical, Biotech, Life Science organizations.
- Extensive hands-on experience deploying and maintaining Veeva (QMS, QDocs, RIM).
- System validation and change management.
- Deep understanding of 21 CFR Part 11 and Eudralex Annex 11 regulations.
- Project management methodologies (PRINCE2, PMP) as well as operational tools such as Six Sigma.
- Experience rolling-out technical roadmap within a regulated environment.
- 8+ years' experience.
This is an exciting opportunity for a seasoned IT leader with experience working in the Pharmaceutical/Biotech/Life Science industry to join a biopharmaceutical company. If you feel you are the right fit for this position, please apply and Akash Solankee from Glocomms will reach out to you directly.