Head of Quality

Head of Quality

Andelyn Biosciences

1, Ohio, United States (on-site)

Posted 23 days ago

Job Type: Full-Time

Job Duration:
Indefinite

Industry: Manufacturing

Min

Experience:

7-10 Years

Min

Education:

BA/BS/Undergraduate

Required Travel: 0-10%

Job Function:
Quality Assurance

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization. Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

The name “Andelyn” is a hybrid of two gene therapy patients who participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

ACCOUNTABLE in our actions.

The Head of Quality is the lead position of the Quality and Regulatory Organization and a member of the leadership team. The Head of Quality will provide strategic and operational leadership to establish, improve, and maintain the quality systems, policies, standards, and procedures. The Head of Quality is to ensure compliance with current US FDA, EMA, and relevant ICH guidance documents.

Ensure the Quality Organization is appropriately resourced and effectively executing a required state of quality and CGMP compliance. The role includes the management of all quality oversight activities related to internal and external manufacturing, contract release and stability testing, and raw material suppliers. The Head of Quality is responsible for ensuring the Quality Organization is adequately staffed in Quality Assurance (QA), Quality Control (QC), Contamination Control, and Regulatory Affairs by attracting and hiring experienced professionals, developing talent, and empowering the team.

The Head of Quality will be recognized across different functions as a partner and will continue to build a quality culture within the organization. The Head of Quality is a recognized role model by providing guidance and coaching to all levels within the Quality Organization and the leadership of the company.

Establish quality strategies to ensure cGMP compliance with US FDA, EMA, and other international regulatory agencies' regulations and expectations.

Direct and oversee the quality planning and execution processes.

Develop short and long-term plans to achieve both quality and business objectives for the organization.

Develop a quality policies strategy consistent with current regulatory expectations for rare diseases and ensure that the quality policies and objectives are clearly communicated, implemented, and maintained within the organization.

Ensure quality systems and processes are appropriate for the development stage of the product and the clinical and commercial application as appropriate.

Ensure manufacturing, testing and release, and distribution of gene therapy products are consistent and meet all relevant regulatory requirements including federal, state, and international regulations, applicable standards, and regulatory guidance.

Develop quality metrics and indicators to proactively identify and address quality systems or product-related issues.

Establish and lead a Quality Management Review (QMR) process to ensure continued compliance with CGMP standards.

Interface directly with the FDA, EMA, other regulatory authorities, and customer clients to ensure the company is appropriately represented in all matters related to compliance and quality.

Direct communications with the…