Qa Validation Manager

Title

QA Validation Manager

Main Purpose

The QA Validation Manager/Sr. Manager is responsible for the oversight and implementation of the Marken Quality Management System (QMS), Marken Standard Operating Procedures (SOPs), processes, and policies required to manage validation life cycles, calibration and maintenance of equipment/facilities used in support of Marken’s global storage, distribution, and logistics operations.

The QA Validation Manager/Sr. Manager will also need to ensure compliance with applicable regional and local regulations including but not limited to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), Good Documentation Practices (GdocP), ISO 13485, and ISO 9001.

Lead a team that will maintain, execute, and monitor the global validation/qualification program, including ownership of the validation master plan, re-qualification schedules, and documentation management.

Main Duties and Responsibilities

• Perform/Support the introduction of equipment, systems, and processes through the validation lifecycle process including but not limited to evaluation, design (URS), installation, operational and performance qualification (IQ/OQ/PQ), calibration and maintenance requirements of equipment, facilities, and utility systems.
• Create, review and/or approve internal validation (VMP, URS, IQ, OQ, PQ protocols, reports, etc), and associated data for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
• Agree and define the quality processes and procedures associated with job role through strategic planning and effective controlled document approval.
• Review and approve vendor supplied calibration and maintenance documentation for conformance to regulations, SOPs, specifications, and other applicable acceptance criteria.
• Maintain and monitor the requalification, calibration, and maintenance schedules.
• Coordinate with equipment owners and external venders to always maintain equipment and facilities in a compliant state.
• Supports site operational teams during fieldwork and execution of validation protocols.
• Evaluate the risk and impact of equipment/facility changes to the validated, calibrated, and maintained status and advise on necessary actions, as applicable.
• Solves complex validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
• Support/Lead complex Marken deviations, CAPAs, risk assessments, and change control.
• Create and deliver training on execution of validation requirements, as applicable.
• Support internal and external audits (e.g., client and regulatory inspections), including the preparation of appropriate documentation, participation as a Subject Matter Expert (SME), when applicable.
• Identify quality KPIs, collate KPI data and reporting associated with Marken’s validation, calibration, and maintenance program. Evaluate KPI metrics to monitor and drive continuous improvement.
• Knowledgeable in 21 CFR Part 11. Provides QA oversight and expertise to computer system validation (CSV) projects across Marken’s Global Network led by the CSV-IT Department.
• Keep informed of regulatory trends, changes in Country/Region and lead the evaluation of changes to internal Marken processes.
• Travel may be required for the performance of duties.

General

• Fluent In English. Multi-lingual (desired), dependent on recruiting area.
• Comprehensive knowledge of GxP regulations - Good Manufacturing Practices and/or Good Distribution Practices.
• Implement and maintain company’s quality systems at the facility, in compliance with Marken’s Global Quality Management System (QMS) requirements.
• Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with employees, leadership teams, customers, vendors, equipment suppliers, and operations staff.
• Organized, methodical and efficient approach to work.
• Excellent verbal, written, and interpersonal communication skills.
• Demonstrated people management skills including training, coaching, motivating, active listening, building trust, conflict resolution skills, ability to prioritize and delegate tasks, manage day-to-day tasks of employees to ensure on-time performance of company goals.
• Perform activities assigned by the QA Director.
• Support QA team to ensure a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

Requirements

• Organized, methodical and efficient approach to work.
• Excellent verbal, written, and interpersonal communication skills.
• Demonstrated people management skills.
• Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with employees, customers, vendors, equipment suppliers, and Operations staff.
• Proficient use of Microsoft Office
• Hands on experience with temperature monitoring devices
• Temperature mapping of CTU’s (controlled temperature units)
• Computer System Validation
• Bachelor’s degree required.
• 5+ years (Manager)/6+ years (Sr. Manager) of relevant validation experience and/or quality experience in a GxP industry or the equivalent combination of relevant education and professional experience.

Marken is a wholly owned subsidiary of UPS and is a critical part of UPS Healthcare. Marken offers a state-of-the-art GMP-compliant depot network and logistic hubs for clinical drug product storage and distribution worldwide, and supports cell and gene therapy logistics services from clinical to commercial, while maintaining the leading position for Direct-to-Patient and Home Healthcare services, biological sample shipments and biological kit production.

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