Manager – PV Validation

Manager – PV Validation

Requirements

• Master’s degree in computer science, Industrial Engineering, or a closely related field (or foreign equivalent degree)
• 2 years of experience in database systems QA
• 1 year of experience in SDLC, managing system implementation and validation projects under change control within the pharmaceutical or biotechnology industries
• 1 year of authoring and reviewing validation deliverables, developing User Acceptance Testing (UAT) scripts, coordinating, and supporting UAT executions
• 1 year of experience in incident management, conducting root cause analysis, troubleshooting to address end user queries and define resolutions
• 1 year of experience in conducting risk assessments for the system upgrades and maintaining the validated state of systems
• 1 year of experience in working with GxP requirements and FDA 21 CFR Part11, EU Annex11 regulations, understanding and monitoring compliance with applicable industry regulations and standards, and company internal SOPs/Policies
• 1 year of experience in collaborating with cross functional teams and vendors for overseeing and documenting Quality events such as incidents, CAPAs and deviations, driving the implementation of remediation
• 1 year of experience in supporting audits and inspection, and vendor management
• 2 years of experience with SQL programming knowledge or any additional data analysis and reporting tools
• Strong communication skills
• Strong problem-solving skills with knowledge of process control, and continuous improvement activities
• Strong project management skills and ability to develop and manage timelines for multiple ongoing projects.

Responsibilities

• Manage the day-to-day operational activities of the PV Systems, including safety databases, and ensure that performed tasks comply with Drug Safety and Pharmacovigilance SOPs and policies, best industry standards, and applicable regulations
• Work closely with drug safety / pharmacovigilance (DSPV) business users to understand system requirements and recommend solutions
• Monitor compliance with regulations, PV agreements and internal SOPs
• Analyze and develop UAT scripts and support during UAT executions
• Collaborate with Quality Assurance Department (CSV) and IT to oversee and document the CAPAs and other quality items to ensure compliance with company and regulatory standards
• Participate in the quality management system in Drug Safety including ensuring department standards are met, including training requirements, monitoring performance, implementing continuous improvement actions and good documentation practices
• Collaborate with Safety database vendor for change controls management, incident management, issues resolutions, and on-going projects
• Act as Project Manager for systems projects within Drug Safety and Pharmacovigilance (DSPV)
• Identify and define solutions to troubleshoot the Safety database.

Preferred Qualifications

• Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism