Senior Quality Assurance Specialist - Contract

About Us

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

As the Senior Quality Assurance Specialist, you will work closely with our CMC team, providing routine QA oversight and support of Contract Manufacturing Organizations and Contract Testing Laboratories for activities including but not limited to manufacturing, qualification/validation, release/stability testing, packaging/labeling and disposition of drug substance and drug product.

This is a 6 month contract role reporting to our Manager, Quality Assurance with the potential to extend the contract period.  This role will ensure adequate quality oversight and support of the development, implementation, and maintenance of relevant quality and compliance initiatives in support of Dianthus’s manufacturing efforts and successful execution of clinical trials and global distribution of product. This role will be responsible for attending routine project meetings, reviewing manufacturing, packaging/labeling, and analytical documents (e.g. master batch records, release/stability data, quality system records (e.g. deviations, change controls, laboratory investigations/out of specification records, etc.) and assisting in batch disposition of drug substance and drug product, including interaction with Qualified Persons to support distribution to the EU region.

You must be adept at working both independently and collaboratively with other business verticals including CMC Manufacturing, Supply Chain, Analytical Development, Quality Control, and CMC Regulatory groups. Experience in Quality Assurance specific to the pharma or biotech industry with knowledge of cGMPs respective to the drug development lifecycle (e.g. clinical phase and commercial) and a comprehensive understanding of regulations and guidelines including ICH, FDA, and EMA as well as experience of Quality Systems including deviations, Out of Specifications, Change Management, Corrective and Preventive Actions (CAPAs), Supplier Management, Batch Release, and Training is required.

We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

• Provides Quality oversight of CMO operations for drug substance and drug product including but not limited to the approval of protocols, master batch records, test methods and raw data, starting material and finished product specifications, analytical test methods, stability reports, and method qualification/validation reports.
• Ensures compliance to cGMP, policies, and procedures for manufacturing operations of products.
• Supports disposition activities for Drug Substances, and Finished Drug Products in support of Product, including QP release.
• Leads in evaluations of Investigations/ OOS/ Change Controls. Supports in root-cause analysis and product impact assessment for investigations.
• Provides Quality oversight of artwork/label review, approval, & implementation for Finished Goods
• Develops relationships with strategic external partners in support of Dianthus’s expanding portfolio and assists with the maintenance of ongoing relationships.
• Conducts ongoing monitoring of regulations and participates in update of Quality documents (policies and procedures) based upon the evolving regulatory environment.
• Performs assessments and QA review of deviations and investigations, including OOS investigations, for products.
• Reviews product release and stability data
• Participates in and/or leads risk assessment for both design and process FMEAs
• Supports GxP supplier audits, as applicable.
• Work collaborative with other members of the Quality team to build and implement phase appropriate Quality systems
• Interact cross-functionally within Dianthus to provide guidance and support across verticals.
• Act as a subject matter expert on quality issues and work to resolve Quality and Compliance-related matters for manufacturing, analytical testing, packaging/labeling, and distribution.
• Conduct Quality audits for development and commercial products.
• Responsible for batch disposition, including drug substances, drug products, and finished products.
• Author and review procedures, specifications, quality reports, and other quality documents, customized to various business processes and requirements.
• Support the Review of source batch records, CoAs, Stability data and regulatory documentation for the products
• Other duties as assigned

Experience

• B.S required in the life sciences or a technical discipline; advanced degree in Chemistry, Biology, or equivalent preferred.
• 5+ years of experience in CMC Quality Assurance in the pharma or biotech industry.
• Minimum of 2 years experience working in small-midsize biotechs.
• Exposure to CMC/Pharma Development and development teams.
• Experience with biologics preferred
• Experience conducting batch disposition of GMP materials
• Experience working in a pharmaceutical manufacturing environment (aseptic filling experience preferred)
• Experience conducting review of analytical test methods and associated raw data.
• Experience conducting and/or participating in risk assessments (e.g. FMEA)
• Experience in development, oversight, and management of CMO quality relationships
• Knowledge of drug development lifecycle and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required.
• Ability to support the development, implementation, and maintenance of client quality systems including facilitating process improvement activities to the product and project teams.
• Working knowledge of cGMPs, ICH, and applicable international regulations and guidelines.
• Ability to evaluate and follow-up on quality events, incidents and possible complaints.
• Understanding of Quality system reviews, deviations, OOS, change controls, CAPAs, and other remediation plans depending on client needs.
• Comprehensive understanding of CFR regulations (21CFR Part 210, 211 etc), ICH guidelines, EMA guidance, quality management systems initiatives, and standards.
• Strong attention to detail and the ability to independently prioritize and multitask.
• Excellent communication skills, both written and verbal