$100K — $150K *
Summit Therapeutics is a biotech company focussing on the discovery and development of novel antibiotics that preserve the microbiome. The lead antibiotic, Ridinilazole, is an antibiotic in Phase 3 of clinical development to cure and prevent recurrence of Clostridiodes difficile infection (CDI). C. difficile is classified by the Centers for Disease Control and Prevention (CDC) among the 5 pathogens being a public health threat that requires urgent and aggressive action. The key clinical challenge of CDI is recurrence of the infection. In Phase 2, Ridinilazole has shown a 60% relative reduction of recurrence compared to the standard of care, vancomycin. This clinical data was associated with preservation of the gut microbiota and bile acid composition, providing a strong mechanistic rational to the lower rate of recurrence.
INFO ABOUT THE ROLE
This position will report to the Senior Director of Compliance, Inspection and Audits within the Quality Assurance department. He /She will be focused on always ensuring GMP compliance for Active Pharmaceutical Ingredient (API) and Drug Product manufacturing processes through the execution of quality systems for inspection readiness.
This position is responsible for assisting in the management of Summit’s quality systems in regulated pharmaceutical environment with regards to US laws, international regulations (where applicable), and Summit’s internal polices and procedures. Furthermore, this position will support the manufacturing and release activities for Active Pharmaceutical Ingredient (API) and Drug Products batches and participate in internal audit program and may assist with vendor audit as needed.
Serve as a QA representative for validation activities performed at Summit’s COMs (Contract Manufacturing Organizations) as required. Expertise in validation and quality risk assessment is required.
Other duties may include but not limited to, assisting in QA management in driving and enforcing CGMPs; mentoring other individuals within the organization in areas of compliance; participate and represent QA in project meeting; reviewing protocols, quality systems document and providing QA inputs; facilitating routine compliance and CAPA meeting including follow up action; facilitating and conduction training.
Main Tasks & Responsibilities:
Assist with all API and drug product manufacturing process for commercial and clinical supply.
Participate in test method development / validation and the release processes for API and Drug products.
Attend scheduled meetings with API and drug product contract vendors and Summit Therapeutics' clinical and commercial operations team to ensure day to day issues associated with API, CTM, & drug products are resolved in a timely manner.
Collaborate with the Directors and Managers – Quality Systems of Summit Therapeutics QA to ensure the audit database in updated and open observations are closed in a timely manner.
Participate and support GMP QA internal & external audit programs. Write audtit reports, and assist in the closure of open audit observations as required.
Generate quality metrics/trends associated with internal and external GMP audits of API, CTM, & drug products vendors so they can be presented periodically during Management Review meeting.
Participate and support the QA leadership in managing all API drug product related quality systems, batch records, & GMP documents to ensure compliance to all domestic and international regulations.
Support all clinical and commercial supply-chain activities following GDP regulations.
Collaborate on day to day clinical and comercial operations including document review such as protocols, validation reports, SOPs, and other documents such as specifications, labels and packaging.
Participation in QTAs (Quality Technical Agreements), SOW (Satement of Work) development with legal and functional area input.
Participate in the presentation of quality metrics as needed
Other duties include but not limited to:
Assisting QA management in driving and enforcing cGMPs
Facilitating routine compliance for CAPA, Deviations, and Change Control meetings including follow up actions.
Assist in conducting company-wide training on inspection readiness, inspection logistics, GxP investigations and root cause analysis.
Minimum of 5 to 10 years of work experience in the pharmaceutical industry with at least 3 years experience understanding analytical chemistry, cleaning validations, and development/commercial manufacturing of Actvie Pharmactical Ingredient (API) and drug product batches.
Working knowledge in micro and analytical laboratory testing is a plus. Experience in the use of e-QMS to effectively execute quality systems such as MasterControl and Veeva Vault is a plus.
Degree/ Msc in Analytical Chemistry or related science
Specialized Knowledge & Skills
Kknowledge of GMP regulations, quality systems, quality assurance, quality control, and conduct of GMP and GLP quality audits.
Additional knowledge and hands-on experience in regulatory inspections, vendor audits, and vendor qualification, and internal audits is required.
High level of written and oral communication skills
Presentation skills, use of Microsoft Office (Excel, Word, Microsoft Project, PowerPoint). Working knowlede of MasterControl is preferred.
Problem Solving & Decision Making
Must have the ability to study and interpret analytical chemistry testing. Possess quality auditing skills and the knowledge as they apply to GMP and GLP operations to conduct audits at various levels in the execution of clinical trials to understand deficiencies for corrections externally and internally without compromise to quality compliance.
Should have sufficient knowledge in GMPand GLP compliance and analytical chemistry expertise to be decisive and be able to educate peers and colleagues at the same time. Shall have the ability to be detail-oriented to understand complex issues and posssess the skills to problem solve with a sense of urgency.
Valid through: 4/21/2021