QA Document Controller – FTC 9 Months

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

Act as the QA Documentation Controller for the business, ensuring that files stored and archived both within the electronic Quality Management System (eQMS; MasterControl) and outside of the eQMS are maintained appropriately according to relevant procedures.

Support validation of the MasterControl system to assure compliance across all sites; supporting project and upgrade re-qualification activities.

Provide first line support to end users for the MasterControl system, providing training as required. Support the Quality Assurance team in other activities where requested.

Major Activities

  • Perform daily administrative tasks for the MasterControl System, including, but not limited to:
    • User Management
    • Document Review, Approval & Release
    • Reviewing Batch documentation
    • Setup and maintain training courses and curriculum
    • Workflow Management
    • User Support
    • eQMS and Document support during Regulatory, Competent authority and Third-Party audits
    • Issuance of Batch Manufacturing Records and Batch Numbers
    • Hard Copy Document Retention and Archiving
    • Organise and manage QA Document Control visibility and activities
  • Author and maintain procedural documents related to the management of documents within the QMS
  • Maintain documentation held externally from the QMS, including document issue, return and archiving as required
  • Support the QMS projects, including partaking in computer system validation activities where required
  • Develop and deliver training related to the QMS and any other role related training as required
  • Support Periodic System Reviews as required
  • Provide Key Performance Indicator Reports for departments as required

Job Background

  • Minimum of 3 years experience working in a GxP environment
  • IT literate, experience managing and operating an electronic QMS
  • English language required

Qualified Person

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

Undertake the duties and responsibilities of the Qualified Person as defined in Directives 2001/83/EC and 2001/20/EC.

Act as GMP Subject Matter Expert (SME) to facilitate site compliance with the company’s Quality Management system.

Ensure systems are identified and in place to maintain compliance with current established GxP standards.

Support senior QA leadership through QP decision making to drive continuous improvement and compliance.

Major Activities and Responsibilities

  • Ensure batches are manufactured and tested to GMP and in line with the CTA/IND and PSF
  • Review completed batch records and complete batch dispositions
  • Develop and own the batch release process
  • Provide QA oversight, technical QA expertise and leadership across all aspects of GMP Operations from Manufacturing, Tech Transfer through Warehouse activities, Engineering, Quality Control, Supply Chain and Operations support
  • Identify, communicate, and escalate quality and compliance risks. Provide direction for and participate in timely resolution, acting always with an appropriate sense of urgency.
  • Attend and participate in the Quality Management Review meetings
  • Ensure that complaints, deviations, and any significant quality incidents are thoroughly reviewed and closed out in a timely manner
  • Ensure changes are appropriately managed
  • Approval of procedures and policies
  • Work as part of the MeiraGTx team to undertake continuous improvement of business quality systems
  • Advise and participate in projects from a quality assurance perspective
  • Keep up to date with regulatory changes and developments, aiding the transition into company SOPs and processes
  • Assist with regulatory inspections providing SME support. Assist in the remediation of regulatory findings and closure of deficiencies.
  • Support self-inspection process, providing coaching to self-inspection auditors and review of the outcomes of audits
  • Strong interpersonal skills must have the ability to establish and maintain effective working relationships with internal and external peers and stakeholders
  • Experience of leading/participation in EU and US competent authority inspections

QA Validation

About MeiraGTx

MeiraGTx is a clinical-stage gene therapy company focused on developing potentially curative treatments for patients living with serious diseases. We currently have six programs in clinical development including three ocular indications, a salivary gland condition, and a Parkinson’s disease program. Our initial focus on diseases of the eye, salivary gland and central nervous system is based on the significant unmet medical need coupled with the high potential gene therapy has to provide meaningful clinical benefit in these areas. With headquarters in New York and London, our global footprint provides us the opportunity to partner with leading institutions around the world, allowing us to deepen our understanding of diseases and their progression.

Our team was built with deep expertise in gene therapy development, allowing us to efficiently advance our programs from preclinical to clinical development. Our core capabilities in viral vector design and optimization and gene therapy manufacturing give us a differentiated approach to developing gene therapies. Additionally, we are developing proprietary technology to potentially enable innovative gene therapy treatments whose expression can be turned on and off with an easily administered small molecule. We believe temporal control of gene therapy products has the potential to transform the gene therapy landscape.

Our state-of-the-art manufacturing facility, completed in early 2018, was designed to meet global regulatory requirements, including the current good manufacturing practices (cGMP) required by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the U.S. Food and Drug Administration (FDA). The 29,000-square foot facility has the flexibility and capacity to produce sufficient product for all our clinical trials and will scale to commercial capacity.

Purpose of Job

To provide QA Validation and Qualification technical support and oversight for the manufacture and supply of Advanced Therapies Medicinal Products (Gene Therapy viral vectors).

This is a key role in;

The QA Validation will play a key role as part of the MGTX Ireland Project team providing hands on and “boots on the ground” QA technical support and oversight to Qualification and Validation activities of the Manufacturing facility and Laboratories, ensuring that processes and equipment are appropriately validated and qualified in accordance with applicable Irish, EU and FDA regulations and MeiraGTx QMS.

Major Activities

  • Prepare and Maintenance of the Irish  site validation plan for MeiraGTx
  • Maintenance and archiving of Validation/Qualificaiton documentation
  • Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure that validation project plans are understood and in keeping with site objectives
  • Clearly communicate and/or provide training in the required validation standard to both the Meira staff and contractors
  • Review and approve validation, qualification protocols and reports
  • Define and manage as system for project-related Deviations and Charge
  • Maintain understanding of cGMP, Good Engineering Practices and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
  • Support generation of Process and QC Equipment Installation, and Operational and Performance Qualifications, review and approve the Qualification protocols, discrepancies and reports for Quality
  • Interface with external consultants and partners as directed by QA Validation and Materials Supply Manager, suppliers and contractors to ensure successful process and equipment validation. Provide QA support to data integrity compliance activities across the site. Write or assist in writing of MeiraGTx Policies, SOPs, work instructions and forms for validation requirements and other quality systems as required.
  • Support Regulatory Inspections and third party audits.
  • Ensure own work complies with GxP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable quality documents
  • Ensure own training is undertaken in a timely and compliant manner before the task is undertaken

Responsibilities

  • To support the implementation “best practice” in validation for a new GMP Gene Therapy manufacturing facility ensuring validation of the processes and equipment meets applicable regulatory requirements
  • To effectively guide the implementation of the Site Validation Master Plan, working with the engineering, operations and QC teams to oversee the commissioning; qualification and validation of the manufacturing facility and supporting activities
  • Participate in risk assessments to develop process validation plans and protocols with Develeopment, 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
  • Extensive experience of GxP compliance requirements
  • 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 List key competencies to fulfil role

Job Responsibilities

Number of direct Reports – 0 (will change over time)

Financial authority – 0 (will change over time)

Job Background / Education

BSC in Science / Engineering

Languages – English

Experience

  • Strong Quality Assurance background working in a Pharmaceutical or Biotech Production environment within sterile manufacturing
  • Extensive experience with providing QA technical support and oversight to validation and qualification activities and with implementing the concepts, legislation, guidelines and requirements related to qualification and validation of sterile products, aseptic processes, equipment and systems, including Computer System Validation e.g. EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9
  • Knowledge of cell culture-based manufacturing techniques and requirements and cellular and gene therapies
  • Experience in using risk assessment tools including FMEA
  • Ability to balance needs of the business with the needs of the Regulatory challenges
  • Proven ability to work successfully in an ambitious, deadline-driven environment and handle multiple tasks simultaneously