What are the responsibilities and job description for the Director, GMP Quality position at Astria Therapeutics, Inc.?
Position Overview
Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
The Director of GMP Quality is responsible for overseeing and ensuring compliance with Good Manufacturing Practices (GMP) for biologics and combination products. This role involves leading GMP product quality assurance activities, ensuring that all products meet regulatory standards and company procedures and policies. The position also includes quality oversight of contracted manufacturers, laboratories, and clinical material supply for clinical products. The scope of this role covers globally manufactured and distributed products, ensuring compliance with FDA, EMA, and other applicable health authority requirements and regulations. The role requires close coordination with internal partners, including Pharmaceutical Sciences/Technical Operations, Clinical Operations, and Regulatory Affairs as well as developing and maintaining strong relationships with external partners.
Responsibilities
At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.
People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, navenibart, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as well as STAR-0310, an OX40 monoclonal antibody antagonist currently in preclinical development for atopic dermatitis (AD) and being explored for other allergic and immunological diseases.
The Director of GMP Quality is responsible for overseeing and ensuring compliance with Good Manufacturing Practices (GMP) for biologics and combination products. This role involves leading GMP product quality assurance activities, ensuring that all products meet regulatory standards and company procedures and policies. The position also includes quality oversight of contracted manufacturers, laboratories, and clinical material supply for clinical products. The scope of this role covers globally manufactured and distributed products, ensuring compliance with FDA, EMA, and other applicable health authority requirements and regulations. The role requires close coordination with internal partners, including Pharmaceutical Sciences/Technical Operations, Clinical Operations, and Regulatory Affairs as well as developing and maintaining strong relationships with external partners.
Responsibilities
- Ensure that all manufacturing processes and products comply with applicable laws, regulations, and company policies, including FDA, EMA, and other global health authorities.
- Coordinate cross-functionally for the continued phase appropriate development of product related Standard Operating Procedures (SOPs), work instructions, and other quality-related documents (phase 1 through commercial)
- Oversee the review and approval of batch-related documentation, including quality event reviews and product release.
- Manage the quality aspects of clinical material supply for both commercial and clinical products, ensuring timely and compliant delivery.
- Oversee and lend expertise to change controls, investigation plans / reports (OOS/OOT, deviations, complaints), and CAPA ensuring adequacy, accuracy and compliance.
- Coordinate and conduct external audits to ensure compliance with GMP standards and report findings. Assess findings and vendor responses, CAPA and escalate as necessary.
- Ensure compliance with global regulatory requirements, including those of the FDA, EMA, and other applicable health authorities.
- Drive continuous improvement initiatives to enhance product quality, operational efficiency, and customer satisfaction.
- Provide training and guidance to Product Quality staff on GMP compliance and quality assurance practices.
- Lead and support regulatory inspections and audits, including FDA audits, and ensure timely resolution of any findings.
- Monitor internal and contracted vendor quality and performance metrics to ensure compliance and performance standards are met.
- Support periodic quality management reviews to assess and improve quality systems and processes.
- Work closely with internal partners, including Astria quality systems, clinical quality, Pharmaceutical Sciences/Technical Operations, Clinical Operations, and Regulatory Affairs to ensure alignment and compliance across all functions.
- Develop and maintain strong relationships with external partners, including contracted manufacturers, laboratories, and contracted quality resources, to ensure effective collaboration and compliance.
- Prepare for pre-approval inspections in support of Biologics License Application (BLA) filings.
- Bachelor's or Master's degree in a relevant field such as Biology, Chemistry, or Pharmaceutical Sciences.
- Minimum of 10 years of experience in quality assurance within the pharmaceutical or biotechnology industry, with at least 5 years in a leadership role.
- In-depth knowledge of GMP, GCP, and GLP regulations and guidelines, as well as FDA, EMA, and other global health authority requirements.
- Strong leadership, communication, and problem-solving skills. Ability to manage multiple projects and priorities effectively.
At Astria, we are committed to building a diverse team where every Astrian endorses the idea that people bring their authentic self to work. We embrace a patient-first, people-always culture which strives to ensure all Astrians and our collaborators have a sense of belonging and receive the support they need to thrive. We invest in our people through our words, our actions, and our values. We are working to develop and implement initiatives that promote diversity, equity, and inclusion throughout the organization and foster a culture of openness, respect, and collaboration, where all voices are heard, and everyone is valued for their unique perspectives and contributions.
People are our greatest asset, and only with a diverse team can Astria shine brighter. Together we can bring our passion and compassion to the work of delivering life-changing therapies to patients, families, and communities.
