Job Description

Development of Validation strategy, Validation Master Plans related to computer systems validation for Syncade. Develop and review of Computer System Validation Artifacts including Validation Master plans, Requirements Specification, Design Specifications, Test Plans (System Test, User Acceptance Test, Regression Testing, Installation Qualification), Test Summary Reports (System Test, User Acceptance Test, Installation Qualification), Traceability Matrix, Validation Summary Report, Release for Use Memo, SOPs, Work Instructions. Develops complete understanding of BMS policies and procedures related to all aspects of computer system validation. Ensure that the validation artifacts meet the quality requirements and applicable regulations FDA, EU, Corporate International Standards. Participate in Validation Cross Functional Teams at corporate and sites (Worldwide) to ensure adherence to required policies and procedures. Liaises with cross-functional SMEs in developing and promulgating the computer system validation methodology. Pre-approve and post-approve validation documentation and assessments from a quality perspective. Provides CSV expertise and guidance related to management, peers, and lower-level professionals. Lead the Validation team to ensure all aspects of activity within the group adhere to required policies and procedures, including safety and training. Participate in the Change Management process ensuring that all changes to validated computer systems are effectively assessed to ensure that regulatory compliance is maintained at all times. Lead the Validation team in preparation for regulatory, internal, and corporate audits and inspections. Represent Validation and BMS for audits and any corporate events (as required). Report out to senior management on Validation status and metrics. Keep abreast of changing regulatory requirements, standards, and guidelines. Mandatory Experience Qualifications and Experiences: The CSV Manager should hold a minimum of a BS qualification (Degree) in a scientific, technical, or engineering discipline along with 10+ years experience in pharmaceutical/ biopharmaceutical manufacturing facilities. A strong background in computerized system validation and Manufacturing Execution Systems (MES). Good technical understanding of IT Infrastructure, manufacturing execution systems (Syncade) and its integration with process automation systems (DeltaV), LIMS (Labware), SAP/Oracle. Strong knowledge of regulatory validation requirements including FDA, EMA, and all other Worldwide Regulatory requirement. Knowledge of FDA regulatory validation requirements including FDA (21CFR, part 11), EMA (Annex 11), GAMP and all other Worldwide Regulatory requirements (ICH Q7, Q8, Q9). Knowledge of Quality principles, computer system development lifecycles, QA methodologies, S88 batch control standards and the and ISA-95 manufacturing plant levels. Knowledge of SOPs, cGMPs and compliance requirements and regulatory guidelines and the technical acumen to work and manage within a regulatory environment. Relevant experience with data integrity requirements and implementation in a GMP environment. Knowledge of leading a successful team to project completion. Problem solving ability and excellent oral and written communications skills. Experience dealing with regulatory agencies and global audit teams. Excellent communication skills and ability to influence others. Skills Desired Demonstrated success working in a matrix team structure to drive collaborative outcomes that meet organizational objectives. Self-motivated with validated personal integrity, judgement and professional maturity and ability to collaborate. Confirmed ability to use structured problem solving and available tools to quickly evaluate problems, identify root causes, create action plans, assess impact, and develop resolution options. Demonstrated leadership ability to: Empower and enable teams thrive in challenging situations, solving complex problems through innovative solutions. Adapt to shifting priorities and dealing with ambiguity. Influence scope and direction of initiatives across multiple organizational levels Drive disciplined and effective decision making. Anticipate risks/issues, assess, and solve problems, holding people accountable for outcomes. Strong communicator via all media: collaboration technologies (SharePoint, MS Teams, etc) and presentations written, emails, verbal - with a wide variety of audiences. Excellent teamwork and interpersonal skills, with the ability to communicate and collaborate with employees and management at all levels.

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