Senior Administrator Job at Revance
JOB SUMMARY
Revance (Nasdaq: RVNC), is a commercial-stage biotechnology company focused on innovative aesthetic, therapeutic, and financial technology offerings, setting a new standard in healthcare.
The incumbent will be a part of the IT R&D team supporting business functions using computerized systems in the Revance Therapeutics Inc Research and Development in areas such as Quality Assurance, Regulatory and Clinical. The administrator will be responsible for implementation of new systems and steady state activities such as user maintenance, periodic upgrades, implementing new functionality, reviewing audit trails and filing quality records as needed – Change requests, Deviation records, CAPAs.
Revance is setting the new standard for our clients through our disruptive products and for our employees through our industry-leading benefits that promote financial and physical health & well-being for all employees. The anticipated base salary for candidates for this open role is $105,00 to $123,000 . The final salary offered to a successful candidate will be dependent upon factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education and geographic location in the within the United States.
ESSENTIAL DUTIES
- Provide technical leadership for steady state operation of supported systems and implementing new systems
- Responsible for performing System Audit Trail Reviews, User Account Maintenance, and System Maintenance Activities as per the applicable governing procedures
- Diagnose hardware and software problems and provide technical support to users in services, installations, and training
- Work with business owners and subject matter experts (SMEs) on IT related aspects of supported systems - determine the end user requirements, and how they can be met
- Be the IT point of contact for user support – troubleshooting, implementing changes to the systems, creation of new users, removing users
- Bridge between business, vendor and IT operations on support requests or troubleshooting items
- Collaborate/lead/participate in decision making and make recommendations to business partners around IT aspects and computerized system functionality pertaining to business requirements
- Generate system specific SOPs for administration of supported systems and ensure compliance with SOPs
- Manage system maintenance and support for the computerized system
- Support assessments for version upgrades/ new release on supported systems
- Support and execute validation activities on supported systems
- Assist and author qualification protocols as required
- Assist and author change controls, CAPAs, deviations as required
- Support activities such as gap analysis on supported systems
- Collaborate with Revance approved vendor personnel in coordinating IT activities on supported systems
- Collaborate with QA on completing IT required aspects of audit trail reviews
- Support Periodic Review activities on supported systems
- Support Regulatory inspections and internal and partner audits and implement corrective actions as needed.
EDUCATION
Minimum Required:
- Bachelor's degree in Engineering, Science or related technological field
Preferred:
- Bachelor's degree in Computer Science, Management of Information Systems (MIS), Pharmaceutical Science, Biomedical Engineering
EXPERIENCE
Minimum Required:
- Minimum of seven (3-5) years or more in the pharmaceutical industry with GxP experience
- Minimum of (2) years or more of direct Veeva Vault Administrator experience
Preferred:
- Candidates who are certified in Veeva Administration
- Candidates with various experience in Veeva RIMS, QMS, PromoMats, Quality Docs, eTMF and CTMS
KNOWLEDGE, SKILLS AND ABILITIES
Minimum Required:
- Strong understanding of FDA requirements as pertaining to the Drug Development Process
- Understanding the software development lifecycle and maintaining the system in a controlled state
- Experience implementing computerized software in a regulated environment
- Experience implementing Veeva Vault systems in a regulated environment
- Understand IT requirements for regulated computer systems – Infrastructure qualification, configuration management, Backups, patching, Disaster recovery and Business continuity requirements
- Knowledge of automation/computerized systems within an FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10
- Demonstrate ability to effectively manage multiple projects/priorities
- Demonstrate excellent written and oral communication skills
- Effective time management and interpersonal skills
- Must work effectively within teams with rapidly changing priorities
- Demonstrates analytical problem-solving skills
Preferred:
- Relevant IT support experience with Veeva systems used within the pharmaceutical industry
- Experience with Quality Management, Regulatory Operations and Clinical Operations processes
- Experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS)
- Experience with Risk assessment and management tools
COMPETENCIES
Key Competencies:
- Integrity, Trust, Ethics, Values
- Results oriented
- Strategic Skills
- Organizing/Priority Setting
- Business Acumen
- Planning
- Decision Quality
- Customer focused
- Conflict Management
- Interpersonal Savvy
- Negotiating
- Problem Solving
- Listening & Approachability
- Partnering
WORK ENVIRONMENT & PHYSICAL DEMANDS
This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 10 pounds at times
We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.
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