Atlas Venture
Director, Quality Assurance
Atlas Venture, Waltham, Massachusetts, United States, 02254
Company Address:
21 Hickory Drive, Suite 500, Waltham, MA, 02451 About Sionna Therapeutics
Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis. Job Description
Key Responsibilities:
Support GMP compliance of manufacturing: Collaborate with CMC team to provide Quality input for strategic CMC development activities, including but not limited to specification development, product release, stability, change management, and vendor management. Ensure current industry standards and health authority guidance are incorporated into CMC strategies. Perform end-to-end Quality oversight for clinical manufacturing and disposition of Sionna products. Oversee GMP compliance of vendors by review of batch records, manufacturing investigations, product release, stability programs, analytical method qualifications, etc. Perform batch record review and disposition related activities for drug substance, drug product, and final labeled drug product. Provide Quality oversight of method development, qualification, tech transfer, and validation for drug substance and drug product activities conducted at external labs and vendors. Lead process for reviewing manufacturing deviations, investigations, and OOS/OOTs, assessing for product quality and program impact. Partner with internal and external stakeholders to drive issue resolution and CAPA identification and ensuring timely closure. Establish and maintain quality oversight of GMP vendors. Perform audits and support technical qualification assessments. Lead negotiation of quality agreements to ensure quality of materials and services. GxP Quality Management / Quality Operations
Develop and maintain quality processes to support GMP and other applicable GxP activities. Author procedural documents (including Standard Operating Procedures and Work Instructions) and provide QA input into procedural documents developed by other functions. Ensure that procedures allow Sionna to meet and demonstrate compliance with all applicable regulatory requirements, standards, and guidance. Oversee audits of other GxP vendors and conduct or support internal audits as required. Coordinate with auditees to communicate findings and track to resolution. Support the implementation of GxP-compliant quality systems across Sionna. Collaborate with Head of Quality, Head of IT, and other stakeholders to implement appropriate systems, tools, and technologies. Collaborate with Sionna colleagues to track and resolve deviations and CAPAs across functions. Perform trending analysis for periodic reviews with senior management. Assess risk and determine solutions that are fit for purpose for Sionna. Minimum Qualifications:
Bachelor’s degree in a scientific field; advanced degree preferred 10+ years of experience in the biotech/pharmaceutical industry, primarily within Quality Assurance, with increasing responsibility and leadership roles Technical expertise with small molecule drugs Experience working with external CDMOs and technical consultants as well as with internal cross-functional stakeholders and senior leadership Experience working in early development and supporting maturation of CMC strategies/Quality processes to later development Experience in working in Quality areas outside of GMP, eg, GCP, GLP, or Operations In-depth knowledge of GMP and GxP regulations and guidelines, including FDA, EMA, and ICH requirements Strong leadership, communication, and interpersonal skills with the ability to influence and drive change Excellent problem-solving and critical thinking abilities Ability to manage multiple projects with aggressive timelines and changing priorities Ability to be agile and collaborate effectively in a dynamic, cross-functional environment Must have valid passport and be willing to travel internationally
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21 Hickory Drive, Suite 500, Waltham, MA, 02451 About Sionna Therapeutics
Dedicated to delivering therapies that could be transformational for people living with cystic fibrosis. Job Description
Key Responsibilities:
Support GMP compliance of manufacturing: Collaborate with CMC team to provide Quality input for strategic CMC development activities, including but not limited to specification development, product release, stability, change management, and vendor management. Ensure current industry standards and health authority guidance are incorporated into CMC strategies. Perform end-to-end Quality oversight for clinical manufacturing and disposition of Sionna products. Oversee GMP compliance of vendors by review of batch records, manufacturing investigations, product release, stability programs, analytical method qualifications, etc. Perform batch record review and disposition related activities for drug substance, drug product, and final labeled drug product. Provide Quality oversight of method development, qualification, tech transfer, and validation for drug substance and drug product activities conducted at external labs and vendors. Lead process for reviewing manufacturing deviations, investigations, and OOS/OOTs, assessing for product quality and program impact. Partner with internal and external stakeholders to drive issue resolution and CAPA identification and ensuring timely closure. Establish and maintain quality oversight of GMP vendors. Perform audits and support technical qualification assessments. Lead negotiation of quality agreements to ensure quality of materials and services. GxP Quality Management / Quality Operations
Develop and maintain quality processes to support GMP and other applicable GxP activities. Author procedural documents (including Standard Operating Procedures and Work Instructions) and provide QA input into procedural documents developed by other functions. Ensure that procedures allow Sionna to meet and demonstrate compliance with all applicable regulatory requirements, standards, and guidance. Oversee audits of other GxP vendors and conduct or support internal audits as required. Coordinate with auditees to communicate findings and track to resolution. Support the implementation of GxP-compliant quality systems across Sionna. Collaborate with Head of Quality, Head of IT, and other stakeholders to implement appropriate systems, tools, and technologies. Collaborate with Sionna colleagues to track and resolve deviations and CAPAs across functions. Perform trending analysis for periodic reviews with senior management. Assess risk and determine solutions that are fit for purpose for Sionna. Minimum Qualifications:
Bachelor’s degree in a scientific field; advanced degree preferred 10+ years of experience in the biotech/pharmaceutical industry, primarily within Quality Assurance, with increasing responsibility and leadership roles Technical expertise with small molecule drugs Experience working with external CDMOs and technical consultants as well as with internal cross-functional stakeholders and senior leadership Experience working in early development and supporting maturation of CMC strategies/Quality processes to later development Experience in working in Quality areas outside of GMP, eg, GCP, GLP, or Operations In-depth knowledge of GMP and GxP regulations and guidelines, including FDA, EMA, and ICH requirements Strong leadership, communication, and interpersonal skills with the ability to influence and drive change Excellent problem-solving and critical thinking abilities Ability to manage multiple projects with aggressive timelines and changing priorities Ability to be agile and collaborate effectively in a dynamic, cross-functional environment Must have valid passport and be willing to travel internationally
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