Manager/Senior Manager, Quality Assurance Software Engineer

Manager/Senior Manager, Quality Assurance Software Engineer
Req#: 51422017




At Elan, we hold a fundamental belief that our science has the potential to improve patients? lives. Our pipeline of developing compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the areas of neurodegenerative diseases, autoimmune diseases and severe pain.



Elan?s commitment to patients is reflected in all that we do: we are a company driven by the knowledge that our work is important and the desire to make a difference. Elan offers prospective employees exciting challenges, unique opportunities for career growth, and a fast-paced environment that emphasizes innovation and achievement.



PRIMARY OBJECTIVE:

To develop Quality and Process system validation guidelines and documentation for use within IT and other associated Elan departments. To conduct audits of internal and vendor systems for compliance with applicable Regulatory requirements and good software development lifecycle practices.

DUTIES/RESPONSIBILITIES:

- Audit internal or vendor systems for evidence of adequate validation activity/documentation;
- Provide validation / change control support around Elan systems to ensure continued adherence with Regulatory requirements and good software development lifecycle practices;
- Develop and assist in implementing validation procedures for Elan systems, including generation of template documentation and SOPs;
- Assist with Quality Control review of Elan validation documentation;
- Act as an internal resource for IT validation expertise and advice
- Act as an internal resource for Clinical sub committees to provide validation expertise and advice around Elan's joint venture initiatives
- Consultant to Information Technology with matters pertaining to infrastructure, system architecture and security

TRAVEL:

Willingness and ability to travel approximately 15-25% of time.


EDUCATION/EXPERIENCE:

Bachelors Degree in scientific area + 6 years experience.

SPECIAL TRAINING/KNOWLEDGE:

' Working knowledge of computer systems and related architecture, including basic hardware and software concepts, LAN/WAN & understanding of systems life cycle methodology. Highly proficient with MS office suite, and in the authorship of validation and guidance documents, including but not limited to: Corporate Guidelines and Policies, SOP's, QA Systems Plans, Risk Assessments. Prior experience in working with Information Technology, and Corporate Compliance Teams.

- Demonstrated Knowledge of ICH Guidelines
- Demonstrated Knowledge of FDA Rules and Regulations, specifically as it relates to 21 CFR Part 11

SKILLS/ABILITIES:

- Thorough knowledge of cGXP system validation practices;
- Clinical development knowledge;
- Ability to work across functions;
- Have broad understanding of critical areas of technical and regulatory focus;
- Excellent communication skills.


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