Executive Director, CMC Quality Assurance

Related keywords: remote job qaquality assurance remote jobremote job worldwide

Overview

Dianthus Therapeutics is committed to developing cutting-edge therapies for patients suffering from severe autoimmune diseases. The company is promoting a revolutionary approach with their lead antibody, claseprubart (DNTH103), which features an extended half-life and improved potency. This innovative therapy allows for less frequent, self-administered subcutaneous injections, targeting specific proteins responsible for disease pathology. Another notable candidate, DNTH212, functions as a bifunctional inhibitor, aiming to achieve significant clinical outcomes while ensuring convenience through an easy administration process.

About the Role

The position of Executive Director, CMC Quality Assurance is pivotal at Dianthus as it involves leading and developing a Quality Assurance (QA) team to bolster the production, development, and regulatory approval processes for all Dianthus products. Reporting to the Vice President, Head of Quality, the Executive Director will design and manage QA processes to ensure global GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) compliance is maintained across various regions where clinical trials are conducted. This role also requires collaboration with cross-functional teams to navigate the complex landscape of global regulatory requirements pertinent to biologic and device-specific products.

Key Responsibilities

To excel in this position, the employee will undertake several responsibilities:

Develop a comprehensive QA strategy to guide drug and device development as well as manufacturing processes. Lead and expand the QA team, incorporating specialists in pharmaceutical and medical device quality. Ensure adherence to FDA, EMA, and other worldwide regulations pertinent to combination products, including 21 CFR Parts 210, 211, and 820, as well as ISO standards. Supervise the processes of event tracking, handling deviations, and implementing corrective and preventive actions (CAPA). Assist the Senior Director of Quality Compliance by conducting supplier audits and monitoring contract manufacturer performance. Offer quality oversight throughout technical development, including reviewing protocols and approving key reports. Act as the primary QA contact during health inspections and corporate governance forums, ensuring regulation compliance. Support regulatory submissions (such as IND, BLA, IDE, PMA) and provide insight as the QA lead during submission reviews. Collaborate with clinical, regulatory, and technical teams to integrate quality measures effectively as projects progress. Provide QA support for nonclinical studies, including GLP audits of toxicology studies. Foster a culture of quality within the organization by driving continuous improvement initiatives. Occasionally, the Executive Director may be required to travel (approximately 20% of the time) for company meetings or vendor audits.

Required Skills and Experience

Candidates must possess a relevant educational background, including a BS or MS degree in life sciences, engineering, or a related field. Essential experience includes:

Significant involvement in biotech/pharmaceutical combination product development. Proven QA leadership experience within life sciences organizations. Deep understanding of GMP regulations, FDA guidelines, and device-specific standards. Extensive experience across various Quality Systems, such as CAPAs, deviations, Out of Specification (OOS) processes, and batch release protocols. A successful record of supporting drug development through to commercialization. Specific expertise with drug delivery systems like autoinjectors. Proficiency in risk management tools, project management, and quality oversight for batch disposition of clinical supply products. Exceptional verbal and written communication skills to facilitate effective dialogue across teams. Strong leadership abilities, demonstrated motivation, decisiveness, creativity, and flexibility in a fast-paced environment. Candidates with experience managing multiple projects and resolving complex challenges will be best suited for the role.

Work Environment

Dianthus operates as a virtual company, empowering remote work within the United States. The unique structure allows employees to operate dynamically, capitalizing on their abilities and skills in a supportive environment. This role not only offers career growth potential but also substantially impacts the therapeutic options available for individuals suffering from autoimmune conditions. A commitment to cultivating a culture centered around quality and collaboration ensures that the quality of life for patients is the priority throughout all operations.

This position is an exciting opportunity to leverage expertise in the QA field while contributing to transformative projects aimed at improving patient care. As part of this expanding organization, the Executive Director of CMC Quality Assurance will play a crucial role in shaping future pipeline projects and furthering the mission of Dianthus Therapeutics.

This job offer was originally published on himalayas.app