To provide QA compliance oversight during the implementation and maintenance of computerized system lifecycle within RD, Corporate and Manufacturing Functions. Furthermore, will be responsible of auditing internal process, systems, and vendors to ensure compliance and adherence to company standards and regulatory requirements.

The Senior Quality Manager has a significant influence over the compliance status of Global GxP Computerised Systems. This role acts as an expert in quality risk management, Computerised Systems validation best practices and industry standards, and in providing stakeholders with a clear understanding of regulatory and compliance requirements for GxP computerized systems life cycle.

Essential Functions

• Provide independent quality review and approval of validation deliverables. Completes independent quality review of validation deliverables associated with assigned systems to ensure that the company policies and procedures, industry standards and regulations are being adhered to.

• Verify that data integrity principles are adhered to within the company.

• Complete relevant testing reviews to ensure that critical scenarios have been appropriately identified and test coverage is adequate and based on a robust risk management procedure.

• Provide expert advice to business owners, system owners, Information Services – Compliance team and wider business operations.

• Collaborate with cross-functional teams to identify and resolve issues related to computerized system validation.

• Contribute to Jazz’s validation practices are up to date, follow industry standards and regulatory requirements.

• Conduct and/or support internal audits, vendor audits and regulatory inspections as a subject matter expert.

• Reviewing and approving change controls for applications and infrastructure.

• Prepare for and supports Sponsor inspections/external audits conducted by national and international regulatory authorities and other external bodies such as marketing partners.

• Promote quality by design awareness amongst company personnel and develop and maintain company GCP, cGLP, GLP, GMP, GPvP and other quality standards by means of training, review, advice, and guidance services.

• Promote a culture of quality excellence that encourages ethical conduct and a commitment to compliance, resulting in a positive image to both company and external personnel.

• Support the Company’s risk-based Quality Management System (QMS) from design, implementation and execution through life cycle management resulting in a culture of continual processes improvement.

Required Knowledge, Skills, and Abilities

• Typically, 10+ years relevant work experience in the Pharmaceutical, Biotechnology or a related industry within Quality Assurance Department.

• Minimum of 5 years’ experience overseeing validation and implementation of computerised systems within a regulated framework.

• Minimum of three years’ experience in life sciences auditing, holding a relevant Lead Auditor certification.

• Detailed knowledge of Computer System Validation Methodologies and sound understanding of risk-based system validation

• Direct experience in implementing systems using Agile.

• Solid Knowledge of GCP, GLP, GMP and/or GVP regulatory requirements. In depth understanding of 21 CFR Part 11, EU Annex 11 GMP, and MHRA GxP Data Integrity Guidance.

• Experience implementing SaaS Systems and working knowledge of office IT packages.

• Good organisational skills and the ability to work independently or as part of team.

• Excellent attention to detail and the ability to identify the root cause of problems.

• Ability to prioritize and manage multiple projects effectively, excellent time management and organizational skills.

• Ability to analyse and evaluate complex technical and professional work activities

• Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically, work effectively in a multi-disciplinary team, build a collaborative network, and to change the thinking of to influence to achieve targets.

• Ability to work on significant issues that impact the success of critical technology projects and related business processes. Exercises independent judgment in selecting compliance criteria for obtaining desired results.

• Ability to work under board direction, self/initiate work and make independent decisions on the impact of processes and procedures that affect the achievement of major organization-wide technology objectives, suggesting viable alternatives.

Required/Preferred Education and Licenses

• Typically, Bachelor’s degree in science or related discipline. Post-graduate qualifications (Master’s, PhD) preferred