GMP Business Application Manager

SCA Pharmaceuticals is a dynamic rapidly growing company consisting of passionate individuals who believe in our mission of providing high quality medications that are critical in saving and sustaining human life. SCA Pharma is an FDA 503B outsourcing facility providing customized medications for hospitals and healthcare facilities across the United States. We do this through unyielding quality, safety and integrity, our commitment to accountability and ownership, teamwork and creating better solutions by simplifying the complex.

Summary:

The GxP Systems Manager is responsible for GxP Compliance of systems under management and oversight of the administration of electronic Quality Management system, LabVantage and other cGMP systems to support quality & lab activities, change controls, internal and external audits, suppliers, document control at SCA.

Essential functions:

• Ensure GxP Compliance of systems under management which includes support of computer systems validation efforts for GAMP5 Category 4 and Category 5 Systems.
• Overall system administration accountability for our eQMS (MasterControl), Laboratory Information System (LabVantage), eMaint, Empower and other cGMP systems.?
• Responsible for planning and implementing upgrades, bug fixes, changes etc. in close collaboration with end-users aligning to established QMS and Change control processes
• Assure good communication between end-users and data owners by e.g., hosting System Steering Groups.?
• Oversight of administration i.e., user maintenance, user assistance, and problem solving for cGMP systems in scope
• Establish and perform Periodic System Reviews.?
• Assure a validated and compliant system status in close collaboration with users, IT QA, System Owner and vendors throughout the cGMP system lifecycle.?
• Ensure system governance by providing data to the Steering Committee.?
• Represent system validation during audits and Inspections for systems in scope?
• Ensure supplier management and oversight of relevant cGMP systems.?
• Develop and maintain SOPs for IT Processes aligning with cGMP and other regulatory compliance needs?
• Lead a team of analysts to support cGMP applications and processes?
• Manage projects / programs involving changes to cGMP systems?
• Manage business stakeholder relationships?for quality, lab and manufacturing teams
• Detail requirements and scope new enhancements and projects for cGMP systems?
• End user training for new changes and processes that impact cGMP systems?
• Ability to work with cross functional teams to develop reporting requirements and metrics relevant for managing business processes covered within cGMP system?

Required Qualifications & Experience:

• Bachelor’s degree
• 3 years management/supervisor experience preferred
• 2 years’ experience handling audits and compliance activities
• 2 years creating policies, SOPs and conducting quality reviews
• 2 years’ experience working with ITIL processes
• Practical experience with FDA 21CFRpart 11, EU Annex 11, and GAMP 5.?

Desired Knowledge, Skills, and Abilities:

• Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint)
• Experience administering MasterControl, LIMS or similar Quality and Lab systems
• Experience working with variety of validation projects including GAMP Category 4 and 5
• Exposure to automated testing scripts and JIRA
• Strong practical knowledge of cGMP and authority inspections.?
• Strong attention to detail
• Goal oriented, with excellent time management and organizational skills
• Excellent verbal & written communication skills

SCA Pharma is an equal opportunity employer (Minorities/Females/Disabled/Veterans). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.