The Sr. Quality Specialist – MFG Facilities will be primarily responsible for providing Quality Assurance support for the design/build and startup of a new Gene Therapy manufacturing facility. Primary duties include the following:
• Provide Quality Assurance support for facility design project team,
• Attend all required project team meetings onsite at design team location and additional locations as required,
• Act as the primary Quality Assurance representative in project team meetings,
• Ensure facility design is capable of meeting cGMP requirements and appropriate regulatory authority expectations,
• Communicate any compliance issues to QA leadership and collaborate with cross-functional stakeholder groups for resolution,
• Approve specifications, change requests and associated project documentation as required,
• Assist in defining requirements for facility, GMP utilities, equipment, systems and analytical instrumentation utilized in the facility,
• Assist in Quality Risk Management process and in the creation of risk assessments for the facility,
• Review and approve system lifecycle documentation for equipment, facilities, utilities, and analytical instruments,
• Review and approve Standard Operating Procedures,
• Provide oversight and guidance for project-based Quality Assurance contractors
Participate in project team meetings as Quality Assurance Representative. Provide input on current industry practice and regulatory expectations. Drive regulatory compliance and assist in resolving compliance issues. Assist in defining requirements for facility, equipment and utilities. Review and approve project documentation deliverables. Assist in the risk management process.
Communicating status and compliance issues with QA leadership. Working with QA personnel and other stakeholders outside the project team in the resolution of project issues and compliance gaps.
Provide oversight and guidance to less experienced team members and project-based Quality Assurance contractors in support of capital projects.
Other assigned responsibilities as established by QA Lead
Education and Experience Requirements
• Bachelor’s Degree in Engineering or Life Sciences,
• 8 years of total combined experience in quality assurance, quality engineering or validation within a GMP regulated manufacturing environment (FDA, EMA, Health Canada),
o Experience working in gene therapy, cell therapy, biologics or vaccine manufacturing facilities,
o Gene therapy manufacturing experience preferred,
• Minimum 4 years of experience in GMP manufacturing facility design-build and/or qualification and startup,
• Intermediate knowledge of relevant regulatory guidance documents and health authority expectations (FDA, EMA, Health Canada),
• Intermediate knowledge of current industry practices and regulatory expectations regarding ATMP manufacturing, clean utilities, qualification, and validation, as well as data integrity requirements for computerized systems,
• Experience with single use technology is a plus,
• Experience with cleanroom facility requirements, multi-product facilities, process flows, and containment requirements for BSL2,
• Demonstrated ability to make informed decisions based on GMP requirements, current industry practices, regulatory authority expectations,
• Ability to communicate effectively with a wide range of personnel/cross-functional teams,
• Capability and desire to perform detailed review of GMP documents,
• Experience providing guidance and oversight of less experienced team members and/or contractors,
• Must be knowledgeable and capable in the following areas:
o cGMP and FDA/EMA biologics, cellular and human gene therapy regulations (preferred),
o Requirements for qualification GMP facilities, utilities, equipment and analytical systems,
o Production of human gene therapy products, preferred but not required
Key Skills, Abilities, and Competencies
• Works under general supervision,
• Strong attention to detail;
• Ability to manage multiple priorities and tasks in a dynamic environment;
• Proficiency with MS Office computer programs;
• Ability to work effectively in a team environment,
• Ability to exercise judgment to determine appropriate corrective actions,
• Excellent written and verbal communication skills,
• Ability to travel occasionally, including internationally – typically less than 10%
Complexity and Problem Solving
• Ability to define problems, collect data, establish facts, and draw valid conclusions;
• Analysis and problem-solving skills, including but not limited to the ability to review and analyze qualification, manufacturing, quality control and validation data;
• Ability to work collaboratively on cross-functional teams in the process of root cause analysis and solution identification,
• Ability to work with peers to ensure conformance to cGMPwhile maintaining a collaborative environment.
Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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