Biopharmaceutical company focused on the discovery, development and commercialization of novel medicines to meet needs in oncology and inflammation and autoimmunity.
Associate Director, Global Quality eSystems
The Associate Director, Global Quality eSystems ensures that the infrastructure and GxP software applications are maintained in a regulatory compliant state. This includes compliance with the FDA's 21 CFR Part 11 in the US and the equivalent international regulations and guidelines e.g. EU Annex 11.
This role will provide quality leadership and guidance to the IT organization through strong collaboration and partnership to ensure that a compliant, efficient, and scalable IT systems and processes enables the execution of organizational initiatives and promotes inspection readiness.
- BS degree in Computer Science or an equivalent degree
- 8 years' experience working in the pharmaceutical industry with a concentration in Computer Systems Quality Assurance.
- Functional understanding of the drug development life cycle from discovery through post approval.
- In-depth knowledge of 21 CFR Part 11, Annex 11 and GAMP 5 best practices, regulations and guidelines.
- Extensive understanding of Data Integrity requirements
- In-depth experience with software development lifecycle methodologies.
- Fluency in IT system structure and function.
- Strong project management skills with the ability to prioritize and adapt to fast-paced business needs while operating in a regulated IT environment and upholding compliance with regulations and procedures as well as customer requirements.
If you meet the requirements above and would like to be considered for this position, apply on-line now to be contacted with further details.