Head of Quality

The Head of Quality is the lead position of the Quality 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 assuring the Quality Organization is adequately staffed in Quality Assurance (QA) and Quality Control (QC) by attracting and hiring experienced professionals, developing the talent, and empowering the team. The CQO will be a recognized across different functions as a partner and will continue to build a quality culture within the organization. CQO is the recognized role model by providing guidance and coaching to all levels within the Quality Organization and the leadership of the company.

What Will You Be Doing?

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 the 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 application.
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 regulatory authorities as appropriate.

What Are We Looking For?

Must have a Bachelor's degree in Microbiology, Chemistry, Biochemistry or related science with >15 years of work experience the biotechnology / biopharmaceutical industry and 10+ years of experience in a Quality role.
Over 5 years Quality management experience.
Experience with leading a Quality Organization including QC and QA is highly desirable.
Must have a comprehensive knowledge of US FDA, EMA, and ICH GxP regulations related to biopharmaceutical and gene therapy regulations and guidelines.
Must have demonstrated experience with regulatory guidelines related to use of viral vector in human clinical applications including gene therapies and rare disease indications.
Experience with hosting and leading client, QP, and regulatory authority audits and inspections.
Develop, implement, and maintain procedures for GMP audit of suppliers/vendors.

EOE M/F/Disability/Vet

Andelyn Biosciences is currently operating under Executive Order 14042 that requires that employees of federal contractors and its affiliates be vaccinated against COVID-19, with some limited exemptions under the law. As Andelyn is both an affiliate and will be a federal contractor, proof of vaccination status will be required prior to first date of employment. Religious and medical exemptions may be considered depending upon the specific job duties and in accordance with applicable federal guidelines.