Senior Quality Assurance Specialist

Summary

Join Dianthus Therapeutics as a Senior Quality Assurance Specialist and provide quality oversight and support to Contract Manufacturing Organizations and Contract Testing Laboratories. This 6-month contract role, with potential for extension, reports to the Manager, Quality Assurance. You will ensure compliance with cGMPs and regulations, review manufacturing documents, and support batch disposition. Collaboration with various internal teams and external partners is crucial. The role requires experience in pharmaceutical QA, knowledge of cGMPs and regulations, and strong communication skills. Remote work is possible.

Requirements

• B.S required in the life sciences or a technical discipline
• 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 batch disposition of GMP materials
• 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

Responsibilities

• Provide 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
• Ensure compliance to cGMP, policies, and procedures for manufacturing operations of products
• Support disposition activities for Drug Substances, and Finished Drug Products in support of Product, including QP release
• Lead in evaluations of Investigations/ OOS/ Change Controls. Supports in root-cause analysis and product impact assessment for investigations
• Provide Quality oversight of artwork/label review, approval, & implementation for Finished Goods
• Develop relationships with strategic external partners in support of Dianthus’s expanding portfolio and assists with the maintenance of ongoing relationships
• Conduct ongoing monitoring of regulations and participates in update of Quality documents (policies and procedures) based upon the evolving regulatory environment
• Perform assessments and QA review of deviations and investigations, including OOS investigations, for products
• Review product release and stability data
• Participate in and/or leads risk assessment for both design and process FMEAs
• Support 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

Preferred Qualifications

• Advanced degree in Chemistry, Biology, or equivalent
• Experience in a pharmaceutical manufacturing environment (aseptic filling experience preferred)
• Experience with biologics

Benefits

We are open to you working remotely