Manager/Senior Manager, Quality Systems & Compliance

Responsible for compliant implementation, maintenance of validated state, control, continual improvement, and management of integrated electronic systems used to support Quality activities such as document & content [electronic Document Management System (eDMS)], learning & qualification [electronic Learning Management System (eLMS)], and quality processes [electronic Quality Management System (eQMS)] and use of applicable Quality Management Systems (QMS) in the performance of this responsibility. This position requires cross-functional collaboration and provision of training and support to enable success of stakeholders across the company for use of these electronic systems ensuring user access, efficient functionality, data accuracy, and compliance with applicable GxPs.

Primary Responsibilities:

Document Management & Control:

• Manage and provide support and oversight for the Document Management & Control system and data integrity initiatives, policies, and standard operating procedure (SOP) ensuring compliance with applicable regulatory standards (e.g. 21 CFR Part 11, data integrity, etc.).

• Participate, provide support for the initiation, review, approval of applicable GxP documentation (Policies, SOPs, Work Instructions, Forms, Templates, Executed Documents, etc.) using the eDMS or hybrid system including in collaboration with Functional Department Head, the assignment of training (i.e., curriculum creation and maintenance) ensuring single source of truth for applicable GxP document and timely performance of applicable periodic review for applicable effective GxP document.

• Provide help and support to GxP document initiator/owner and reviewers/approvers ensuring compliance with quality system element SOP, eDMS-related SOPs & Work Instructions, and assists users with eDMS workflow and related issues when needed.

Training, Learning & Qualification:

• Provide support, review, approval of applicable training related contents (creation/approval of curriculum, courses, modules, scheduled courses, recorded Instructor Led or Trainer-Delivered Training, learning materials, etc. including training assignments, and assessments where applicable) in collaboration with Functional Area Head ensuring content and trainee eLMS transactions are processed and completed with applicable Training policy, SOP, and eLMS-related SOP & Work Instructions.

• Provide report to monitor trainee progress and/or qualification status, course and or training assignments, and assessment of training effectiveness (as applicable) and compliance.

• Provide management, oversight or support for the GxP Training Program ensuring its ongoing effectiveness and alignment with GxP job function and description in collaboration with Functional Area Department Head.

Electronic System Implementation, Maintenance of validated state, Control, Continual Improvement, and Management:

• Review and approval of change management activities for new or revised computer system validation including corresponding Validation Plan, Configuration Traceability, User Requirements Specification (URS), User Acceptance Testing/Performance Qualification (PQ) Protocols and Reports, Requirements Traceability Matrix (RTM), Deviations/Non-conformance, Validation Summary Report, and Release documentation to maintain a validated state of the system and maintenance of system documentation.

• Creation/Review/Approval of related supporting documentation such as standard operating procedures and/or working instructions for system operation; user training/access/use; preventive maintenance (as appropriate); physical, technical, and procedural security; monitoring and related actions for system errors, deviations and incidents; back-up & recovery (as appropriate); archival & retrieval of records; and disaster recovery.

• Providing user training on electronic system/application function and features; and applicable read-only and elevated user access (account, permission, role) and provide support to users to resolve issues.

• Review and approval of Release Management Risk Impact Assessments in coordination with Keros IT for any vendor notification, support, updates and/or patches, as applicable, that impact system availability, validated state, performance, and data integrity.

• Identification and implementation of continual improvement and operational efficiency (e.g. configuration change management, implementation of new modules, templates, or workflows) based on new quality processes, business needs, and user feedback.

• Detailed understanding of applicable system administration and workflow aspects of the integrated electronic systems particularly Veeva Vault Quality Docs and ComplianceWire, and Veeva Vault QMS ensuring to achieve sustainable compliance in applicable GxP operations.

Quality Management System:

• Develop, implement, maintain and continually assess an eQMS for GxP Change Control; Quality Events-Deviation Management; Continuous Improvement (Corrective and Preventive Action-CAPA) and corresponding supporting applicable electronic child workflow such as Amendment; Effectiveness Check; Extension Request; Issue Escalation; Supplier Change Notification; and Supplier Corrective Action ensuring applicable regulated activities to meet internal company standards and external regulatory requirements.

• Participate, provide support for the initiation, review, approval of applicable GxP Change Control; Quality Events-Deviation Management; Continuous Improvement (Corrective and Preventive Action-CAPA) and supporting electronic child workflow using the eQMS or hybrid system.

• Provide help and support to eQMS document initiator/owner, reviewers, approvers, and users ensuring compliance with quality system element SOPs, eQMS-related SOP & Work Instructions, and assists users with eQMS workflow and related issues when needed.

• Assists with generating and providing Quality metrics (Reports and Dashboards).

Compliance:

• Participate in internal audits and/or compliance assessments, risk mitigation activities related to the electronic systems.

• Provide Subject Mater Expert support and related documentation (e.g. training records, applicable GxP documents, system validation documentation, etc.) during regulatory inspections and internal audits.

• Maintain current knowledge base of regulations, corporate policies and standards to ensure that the electronic quality processes and the quality management system remain in compliance with applicable regulatory and corporate standards/requirements and current with industry trends and best practices.

• Complies with applicable, laws, regulations, QMS processes and requirements, including demonstration of positive work ethics and integrity in any and all matters and at all levels throughout the company.

Performs other related duties as assigned.

Qualifications:

• Bachelor's Degree is required (Computer Science, Biological sciences, Engineering or related degree).

• Minimum of 5 years related experience in the Pharmaceutical/Biopharmaceutical/Biotechnology industry.

• Experience with System Administration of integrated electronic systems particularly Veeva Vault Quality Docs and ComplianceWire (equivalent eLMS), and Veeva Vault QMS is a plus.

• Knowledge and experience in implementing GAMP 5 Category 4 configurable software and a collaborative, right & positive attitude, compliant, entrepreneurial, and action-oriented mindset is a plus.

• Document Control/Records Management, QMS, and Training Coordinator experience required (paper-based, electronic or hybrid system).

• Broad understanding of international regulations and guidance documents, FDA & EMA Regulations, ICH Guidelines, and GAMP.

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