Sr Specialist, Supplier Quality

About Forge

Forge, a member of Ajinomoto Bio-Pharma Services, is a gene therapy development engine focused on enabling access to life changing gene therapies and helping bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most.   

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as the Hearth. The Hearth is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services. 

About the Role

We are currently seeking a Sr. Specialist, Supplier Quality to join the Forge Biologics team. In this role, you will be responsible for the quality oversight of GMP suppliers and service providers.  The Sr. Specialist will provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. In this role, you will be responsible for ensuring the quality and compliance of our suppliers, playing a crucial role in maintaining the safety and efficacy of our clients' products

 

What You’ll Do

• Develop and maintain relationships with suppliers to ensure timely delivery of high-quality materials and services
• Evaluate and qualify potential new suppliers thorough audits and assessments, in accordance with company and regulatory requirements
• Coordinate the scheduling of supplier audits with quality team members and serves as an audit team member, as required.
• Monitor and assess supplier performance, identifying and addressing any quality issues or non-conformances
• Develop and maintain supplier quality agreements, outlining expectations and requirements for quality and compliance
• Collaborate with cross-functional teams to address any supplier-related quality issues and develop effective corrective and preventative actions
• Conduct risk assessments and implement risk management strategies to ensure the safety and efficacy of our clients' products
• Stay updated on industry regulations and standards related to supplier quality, and ensure compliance with all applicable regulations
• Lead supplier quality improvement initiatives to drive continuous improvement and ensure the highest quality standards are met
• Train and educate internal teams on supplier quality processes and requirements
• Collaborate with suppliers to implement quality improvement programs and initiatives.
• Manage and lead efforts for supplier change notifications and complaint/corrective actions.

 

What You’ll Bring

• Bachelor’s Degree in a scientific or related field (or equivalent work experience)
• 3 years+ auditing experience
• Experience working in an auditing role within the Pharmaceutical/Medical Device industry
• Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ISO, and related International Regulations affecting pharmaceutical products and medical devices
• Working knowledge of industry related guidelines such as ICH Q7, GHTF, and IPEC
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.
• Strong analytical and problem-solving abilities.
• Attention to detail and a commitment to ensuring compliance with regulations and quality standards.

 

Preferred Skills

• Experience working in the production of biologics (ex. gene therapies).
• Familiarity with regulatory requirements for gene therapy products, AAVs, and relevant guidelines (e.g., FDA, EMA, ICH).

 

Job Environment & Physical Demands

This position works in a typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. This is largely a sedentary role; persons holding office positions are generally subject to inside environmental conditions having the lighting, temperature, and noise of an open floor-plan office environment. Regularly operate a computer and other office equipment. Regularly communicate with others in person, over the phone, and electronically. M