Job Summary: The Senior Manager, Quality Validation, is responsible for the system administration and validation life cycle of the laboratory systems and other computerized systems. This role involves managing, designing, and coordinating software installation, updates, and services. This individual will be responsible for the oversight of systems to ensure data integrity and quality assurance for the system's intended use. Systems include a custom LabWare LIMS system, a Waters Empower chromatogram system, a Veeva Quality Management system, a SAS system and others. You will be part of a unique opportunity that will shape the future of Supernus. There is an emphasis on using modern technology supported by the Supernus Management Team that will help increase your skillset, as well provide growth at Supernus. Essential Duties & Responsibilities:
- Manage (e.g., administration, troubleshooting and maintenance) all laboratory data systems and associated computer workstations for the Analytical Science (AS) and Quality Control (QC) laboratories.
- Responsible for activities related to application upgrades and implementations, including review and validation of functionality, and reporting of issues.
- Determine risk and compliance assessments as needed to meet Regulations or business needs (e.g., GxP, GAMP).
- Ensure qualification protocols for computerized data systems are executed in accordance with FDA regulation and guidance and GAMP 5.
- Assist System owners in identifying new system requirements, including the need for validation and/or verification testing.
- Ensure Standard Operating Procedures (SOPs) remain aligned with current needs.
- Initiating change control as needed.
- Maintain the system/application validation life cycle.
- Manage relationships with vendors and/or consultants to deal with technical issues and/or project initiatives.
- Responsible for meeting deliverables as assigned.
- Maintain systems in a state that is compliant with current industry practices.
- Periodic evaluation of each system to ensure it remains in a validated state.
- Budget responsibilities.
- Collaboration with other departments as needed.
Supervisory Responsibilities:
- Managing 1 or more direct reports.
- Assign tasks/workload for the team.
- Perform employee performance reviews and establish annual employee goals.
Knowledge & Other Qualifications:
- BA/BS degree in a computer science or other science-related discipline.
- 6+ years of related experience in a GxP environment.
- 3+ years of Leadership experience.
- Extensive computer skills and knowledge of computer systems and software applications. Specific knowledge of Waters Empower Chromatography Data Systems (CDA), LabWatch monitoring system and LabWare LIMS system is strongly preferred.
- Knowledge of computer validation methodologies, principles, and software development life cycles, including change management.
- Fundamental knowledge FDA regulation such as 21 CFR Part 11 and software validation guidance.
- Fundamental knowledge of GAMP 5 Risk-Based Approach to Compliant GxP Computerized Systems.
- Strong organizational skills with attention to detail and accuracy.
- Clear, concise, and effective written and oral communications.
- Knowledge of Crystal reports is preferred.
- Understanding of cloud-based technology such as IaaS, PaaS, and SaaS.
- Knowledge of Oracle administration is preferred.
Other Characteristics:
- Ability to work independently and as part of a team
- Maintain high ethical standards regarding data integrity and data security.
- Problem solving skills; the ability to systematically analyze problems, draw relevant conclusions and devise appropriate courses of action.
- Ability to multitask and drive projects to resolution and successful implementation.
- Dependable, reliable, and flexible, when necessary, with excellent time management skills.
- Capable of performing other duties and responsibilities as assigned or directed by Management.
- Authorized to legally work in the United States without visa sponsorship.
Physical Requirements / Work Environment
- Position may require prolonged sitting, standing, walking, reaching, twisting, turning, kneeling, and bending; the ability to push, pull, drag and/or lift to 25 pounds; normal manual dexterity and hand/eye coordination; repetitive hand movement using a computer keyboard and mouse.
- Required to have close visual acuity to perform activities such as viewing a computer monitor and reading.
- Will be required to occasionally wear personal protective equipment to include but not limited to gloves, safety glasses or goggles, face shields, lab coats.
Supernus Pharmaceuticals is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, age or any other characteristic protected by law.
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