This job has expired

Sr. QA Specialist

Employer
Spark Therapeutics
Location
Philadelphia, Pennsylvania. Hybrid and remote options available for select opportunities.
Salary
Salary not provided
Closing date
Sep 3, 2022

View more

Discipline
Other, Manufacturing/QA/QC
Organization Type
Pharma
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Job Details

Summary

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

Responsibilities

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.

#LI-JL1

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.


Nearest Major Market: Philadelphia



Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Learn more about Spark Therapeutics and view other openings.

Company

At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.

Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.

Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are designed to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.

Find Us
Website
Telephone
215-989-1149
Location
3737 Market Street
Suite 1300
Philadelphia
PA
19104
United States
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