IT System Manager - US
Posted on Sep 14, 2020 by Ascendis Pharma
Do you want to be part of building a fully integrated biopharmaceutical company together with a team of highly skilled colleagues who are passionate about developing best-in-class therapeutics that address significant unmet medical needs? Then Ascendis Pharma is committed to support your personal development on our journey towards becoming a leading rare disease company.
Ascendis Pharma is looking for an experienced IT System Manager to join our team. This is an exciting opportunity to join a rapidly growing, innovative company!
The IT System Manager role is part of a team that develops, implements, manages, maintains, and supports various business applications and systems. The individual in this position is responsible for various activities including an understanding of the business process, user and functional requirements, and configurations surrounding the use of the system; and works with a cross functional team to help configure, deploy and maintain the system capabilities and/or upgrades. The position will be based in Palo Alto and will report directly to the Head of US IT.
* Serve as the System Manager for IT Systems enabling research, clinical, quality and regulatory business processes with technology platforms such as Study log, Dotmatics, Veeva Vault, Quentic, etc.
* Responsible for the software solution including processes, requirements and configurations surrounding the use of system; including regulatory (GxP, SOX) compliance, where applicable.
* To coordinate and manage continuous improvement of IT Systems and processes across Ascendis.
* Act as a trusted advisor for internal stakeholders and a liaison to suppliers of relevant services supporting the above areas; manage stakeholder expectations and ensure business needs are understood and supported with current and planned functionality.
* Facilitates workshops and translates user needs into user requirements and use cases.
* Work closely with solutions architect to identify the optimum combination of applications that meet the requirements of business functions.
* Develop short-term and long-term roadmaps aligned with business goals and technology governance.
* Lead a team responsible for the implementation and maintenance of system capabilities and/or upgrades.
* Perform design/code/build reviews to ensure software code and configurations meet standards.
* Coordinate with cross-functional stakeholders such as IT Infrastructure, QA, Business Owners, Software vendor etc., to ensure project deliverables meet business expectations and timelines.
* Responsible for system administration and technical support, including
* resolution of access requests, and incidents.
* change and release management.
* development of training material and conducting end user training.
* escalation and coordination of support requests to software vendors and integration partners.
* conduct periodic reviews to ensure compliance to GxP, SOX regulations.
* Work directly with customers to probe and ask effective questions to fully diagnose both the root cause of a problem and the customers comfort level with technology.
* Contribute to the support and maintenance of validation package in compliance with validation/documentation procedures as per SDLC methodology.
* Contribute to the support and maintenance of operational documentation including SOPs, work instructions, manuals, and training materials for end users and system administrators.
* Assist with critical data support and data analysis requests from internal stakeholders.
* Monitor system infrastructure health and performance regularly to ensure continuous system availability for 24x7 operational sites.
* Remediate security vulnerabilities on time to mitigate any security risks associated with the system software or server infrastructure.
* Communicate pertinent system information to site/project leadership as needed.
* A Bachelors Degree in Computer Science, Chemistry, Biochemistry or related discipline with a minimum of seven (7) years of experience, OR a Masters Degree in Computer Science, Chemistry, Biochemistry or related discipline with a minimum of four (4) years of experience.
* A minimum of three (3) years of experience in a pharmaceutical and/or biotech industry.
* Strong Business analysis and configuration/development skills.
* Understanding of the regulatory requirements in pharmaceutical development and manufacturing area.
* Experience in implementing technology road-map under a defined corporate methodology.
* Experience in helping across all aspects of Software Development Life Cycle (SDLC) and Validation Life-cycle (VLC) methodology.
* Experience leading or managing Research, Laboratory and/or Clinical suite of applications is required.
* Knowledge of Research and Clinical systems such as Dotmatics, Veeva Vault, etc., is preferred.
* Experience defending computer system validation package in front of auditors (external/internal) is preferred.
* Working knowledge of Current Good Manufacturing Practices (cGMP), 21 CFR Part 11, Annex 11, Compliant GxP Computerized Systems (GAMP5), and other regulatory requirements or policies is preferred.
* Structured, analytical and independent work approach.
* Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation.
* Excellent planning and organizational skills.
* Strong written and verbal communication skills.
* Ability to communicate effectively with technical and non-technical audience.
* Excellent analytical, problem-solving and technical skills.
* Detailed oriented, systematic and rapid learner.
* Ability to work in a fast-paced environment.
* Ability to travel 5-15 days per year domestically and internationally.
* Medical insurance
* Vision insurance
* Dental insurance
* Paid maternity leave
* Paid paternity leave
* Commuter benefits
* Disability insurance