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Quality Assurance – Contractor (Director/Senior Director level)

Sionna Therapeutics is a life sciences company dedicated to redefining what’s possible in cystic fibrosis treatment. We are developing highly effective and differentiated treatments for cystic fibrosis (CF) by normalizing the function of CFTR, the key protein associated with disease progression in CF. Building on over a decade of extensive research on the genetic mutations associated with CF and founded in 2019, Sionna is advancing a pipeline of small molecules engineered to correct ΔF508, the most common mutation that affects the CFTR protein. The company has a first-in-class portfolio of programs targeting correction of NBD1, the key and unique mechanism to enable full restoration of ΔF508-CFTR function, and complementary programs targeting ICL4 and TMD1 domains. Sionna’s pipeline has the potential to deliver best-in-class efficacy and reach previously unachievable levels of long-term benefit for people with CF.

Position Summary

Sionna Therapeutics is looking for an experienced Quality Assurance professional to provide part-time support on a 1-year contract.

  • The position will require approximately 25 hours/week; may increase for specific weeks with advance notice, eg due to travel.
  • This is expected to be a 1-year contract position.
  • The role will be a hybrid or remote position, generally working on Eastern time, with occasional travel to Sionna and to vendor facilities (US/international).
  • The responsibilities are primarily GMP-focused (~80%) but the individual will also support other GxP activities, especially audit oversight and quality systems.

We are accepting resumes for the position at careers@sionnatx.com.

Key Responsibilities:

Support GMP compliance of manufacturing strategies

  • 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.

GxP Quality Management

  • 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.
  • 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.
  • 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 (including selection and validation as required) 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.

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
  • 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