Validation Manager

Validation Manager

The role is required to provide Validation support for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors) for our client based in Shannon,   The role will have 5 direct reports and additional contractors reporting to this function.

This is a key role in ensuring that site meets qualification / validation regulatory and MeiraGTx requirements. 

The role will provide Validation Expertise for validation and qualification activities across the Manufacturing facility and Laboratories.

To ensure computer systems, equipment, facility, utility and processes, are appropriately validated and qualified in accordance with all applicable regulations EU, FDA, JP as applicable 

The role will ensure that all Validation Policies and procedures within MeiraGTx are compliant with applicable regulations and guidelines e.g. ISPE 

The role will provide guidance to the Validation team to ensure that all procedures are simple, clear and unambiguous.

The role will work with the Validation team in the London facility to ensure that both sites adopt the same validation approach, Note the validation procedures are global between the London and Shannon manufacturing sites.

Major Activities

• This role will be the key participant during site audits and inspections and must be able to clearly understand and explain all site Validation activities to regulators. 
• Interface with other departments such as Engineering, QC, System Users. System Owners, process, Automation / CSV, Warehouse, QA, QA Validation and Manufacturing to ensure that validation project plans are understood and in keeping with site objectives. 
• Generate, review and approve validation, qualification, plans, protocols and reports or assign designee. 
• Understanding of cGMP, good engineering practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities. 
• Interface with external consultants, suppliers and contractors to ensure successful utility and equipment validations are executed per agreed deliverables and managed within approved PO budgets. 
• Write or assist in writing / reviewing of MeiraGTx Validation Policies, Validation SOPS / Templates for site. 
• Coordinate, track and report all Validation and qualification activities across projects and routine operations.
• Elevate awareness to team members / departments about issues that could impact adherence to the qualification / validation requirements. 
• Propose options to take corrective actions to avoid delays and optimize the schedule for qualification / validation activities for the site. 
• Aid in investigations and troubleshooting as part of a multi-functional team to determine solutions or recommendations for changes and/or improvements where qualification validation input is required. 
• Coach validation team members regarding validation / qualification best practices. 
• Act as point of contact for assigned project related communications with team and stakeholders 
• Reviewing completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria or assign designee 
• Analysing the results of testing and deciding the acceptability of results against pre-determined criteria or assign designee.
• Experience in preparing Defining Process, Performance Qualification plans and reports to support regulatory filings.
• Experience in setting up Continued Performance Validation program for commercial products.
• Comply with MeiraGTx procedures including Health and Safety and GMP, ensure that all validation work is completed according to risk assessment or site procedures. 

Key Performance Indicators 

• To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes, facility, utility analytical and process equipment meets regulatory requirements. 
• To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the qualification and validation of the manufacturing facility. 
• Participate in risk assessments to develop process validation plans and protocols with Development, Operations and QC staff. 
• Implement robust and ‘fit for purpose’ validation procedures ensuring the facility, equipment, and processes are validated, qualified and maintained to regulatory requirements. 
• All responsibilities are performed in a timely manner, escalating any and all issues to senior management as and when they occur. 
• Recommend improvement in validation management practices and documents.

Key Job Competencies  

• The individual must have an established track record in delivering robust and regulatory compliant Validation Plans and Protocols, must have the ability to interpret the regulations and guidelines to deliver a simple clear validation approach.
• The individual must have an in depth working knowledge of regulatory requirements specifically eg Eu GMP Annex 1, annex 11, annex 13, annex 15, FDA 21CFR part 11 and all relevant ISPE guidelines.
• Experience in communicating with regulators during site regulatory inspections.
• Able to Interact with other departments and personnel across the business both orally and in writing, demonstrating good interpersonal skills. 
• Can identify and escalate issues to line management, to ensure workload is prioritised, issues are highlighted to ensure business needs are met. 
• Able to respond flexibly and adapt to the needs of the department/wider business, demonstrating good organisational and time management skills.

Job Responsibilities 

• Responsible for ensuring that own work and that of the team complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures.
• Responsible for ensuring that own training and that of the team is undertaken in a timely and GMP compliant manner before the task is undertaken.
• Responsible for ensuring that any GMP documentation e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions, within own area of responsibility, is closed timely and in a RFT state.

Job Background

• BSc/MSc or BEng/MEng in Engineering or related discipline.
• 7 - 10 years minimum in validation, quality systems, operations, engineering or any combination thereof.
• Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
• Experience with managing teams in a GMP manufacturing environment. 
• Validation experience using risk based approach guidelines, international regulatory requirements and standards and other in.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.

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