Head of Quality

Overview of Andelyn Biosciences 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. Through this journey, we have been able to accelerate the development and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality through our ACCTSions. Employees are expected to perform the following essential functions under the framework of our ACCTSions. What you will do. 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 will ensure compliance with current US FDA, EMA, and relevant ICH guidance documents. They will oversee 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. They will provide 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 regulatory authorities as appropriate. Exercise discretion, judgment, and personal responsibility. Demonstrate a high level of integrity. Maintain a positive attitude. Attention to detail in all job functions. Performs in accordance with established policies, procedures, and techniques and requires training common experience, or working knowledge related to the tasks performed. Develop strategic planning and guidance for their functional unit in alignment with the overall organization and influence organizational strategic planning on an executive level. Develop and define measurable objectives for the staff within their functional units to fit the objectives of the overall organization. Also is involved in organizational objectives on an executive level. Cultivate a diverse and collaborative team environment. Utilizes clear and concise communication to ensure high productivity and contribution to the success of organizational goals. Ultimate oversight on the development and enforcement of procedures and controls. Establish a strategic process to control work procedures. Complete budgetary control over the functions under their control also influences organizational budget establishment. Some travel is required. Responsible for hiring, development, and related personnel processes. Mentoring and professional development of staff. Make use of essential people skills, including the ability to develop subordinates. Ability to manage and influence people in direct and lateral support structures. Ultimate decision-making latitude within their functional units and influences decisions on an organizational level. Drives timelines and development through broad influence. Ultimate interaction with legal services. Develop and direct short and near-term goals. Responsible for developing a 3–5-year business plan. Responsible for Revenue (P&L). Interprets Regulations for application within their functional unit. Has business acumen and considers business impacts in planning and problem-solving. Responsible for business development. Other duties as assigned. What you bring to the team. Must possess a relevant four-year degree OR relevant Masters OR relevant PhD, background in the life sciences, biotechnology or gene therapy industries preferred. Expert business knowledge with a comprehensive understanding of the organizational and functional areas. Advanced Leadership skills. First-level executive responsible for a sub-set of a functional area or responsible for division-level. Excellent communication, organization, and project management skills with the ability to manage multiple projects efficiently and adjust as priorities change. Must be highly skilled in Microsoft Office (PowerPoint, Excel, Word) including data interpretation and reporting. Ability to work independently as well as collaboratively in a diverse and inclusive work environment. Must possess a client-focused mindset in daily tasks. Must possess prior experience handling confidential information and the ability to maintain confidentiality. What you can expect when working at Andelyn. The pride in contributing to the development and manufacturing of lifesaving therapies. The invaluable experience of being a part of building the foundation of a new organization. The opportunity to work alongside experts who have over 10 years in the gene therapy field. Competitive compensation. Eligible on day one for medical, dental, and vision insurance plans with basic vision at 100% company-paid. 160 hours of Paid Time Off annually, increases to 200 hours after 4 years of service. 11 Company Paid Holidays plus 2 floating holidays annually. Company Paid Life Insurance. 401(k) Match. Company Paid short and long-term disability. 4 weeks of Paid Parental Leave for birth and adoption. Adoption Assistance. Tuition Reimbursement and Student Loan Repayment Assistance. Company Paid LinkedIn Learning access. Employee Assistance Programs. Flexible work options (role specific). Equal Opportunity Statement Andelyn Biosciences embraces diversity and is an equal opportunity employer and does not discriminate based on race, religion, national origin, gender, gender identity, genetic information, sexual orientation, protected veteran status, disability, age, or another legally protected status. As an organization, we are committed to creating an environment where everyone ACCTS. #J-18808-Ljbffr Women In Bio