At DICE Therapeutics, we design and develop innovative therapies in immunology for patients with debilitating disease. Seeking to create a future where convenient oral medicines with biologic-like efficacy are available to patients with serious medical conditions, we are developing oral alternatives to medicines currently limited to injectable forms.
We seek an exceptional Sr. Manager, Clinical QA to join our QA organization. This individual will be a key contributor to the Quality Assurance activities related to Good Laboratory Practices (GLP) and Good Clinical Practices (GCP).
Reporting to Sr. Director/Head of QA, the Sr. Manager, Clinical QA will be primarily responsible for managing and supporting the Quality Assurance activities related to GLP and GCP for early and late-stage clinical development through commercialization for DICE’s small molecule programs.
In this role, you will collaborate with external partners and DICE internal stakeholders across the organization, but most significantly with Non-Clinical Operations, Clinical Operations, Clinical Informatics, Data Management, and Pharmacovigilance colleagues. You must be a self-starter, creative problem-solver and able to flex with a growing fast-paced environment.
- Quality Assurance designee for Head of QA in clinical team and project meetings with Contract Service Providers (CSPs).
- Assure adherence to GxP/ICH (FDA, ex-US, country-specific) regulations, DICE Standard Operating Procedures (SOPs), and current industry best practices in conduct of non-clinical and clinical trials, as applicable.
- Review critical to non-clinical and clinical trial quality assurance processes and SOPs to identify gaps and work with cross-functional colleagues to assess compliance risks and risk mitigation strategy.
- Collborate with cross-functional colleagues and develop non-clinical and clinical (GLP/GCP) Quality Management Systems (QMS) procedures in compliance with applicable regulations and industry best practices.
- Work with cross-functional teams to develop clinical quality plans.
- Review and provide input to clinical documents such as protocols, amendments, Investigator’s Brochure (IB), Informed Consent Forms (ICFs), study plans, Clinical Study Reports (CSRs) and other relevant documents etc.
- Perform audit of Trial Master Files (eTMFs ) and ensure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPs.
- Review and approve change controls, SOPs, and working instructions ensuring compliance with regulations and best practices.
- Assist in timely resolution of quality and compliance issues at non-clinical CROs, clinical CROs, clinical sites, investigator sites, laboratories, and other support services vendors.
- Assist Head of QA in review and approval of deviation/non-compliance investigations, corrective actions and preventive actions (CAPAs) related to non-clinical CROs, clinical CROs, clinical sites, investigator sites, laboratories, and other support services vendors, as applicable. Ensure adequacy of root cause analysis, CAPAs, effectiveness checks (EC) and follow-up with CAPA implementation.
- Escalate quality risks, data integrity, and compliance issues to Head of QA, non-clinical operations, and clinical operations team.
- Participate in selection of potential non-clinical operations and clinical operations CSPs.
- Assist Head of QA in conducting audits of CSPs (non-clinical CROs, clinical CROs, clinical sites, investigator sites, laboratories, other support services vendors, and computer systems etc.) based on risk assessment and establishing quality agreements, as applicable.
- Support Head of QA in conducting site monitoring visits for GLP activities.
- Assist Head of QA in inspection readiness preparation and regulatory audits.
- Assist Head of QA in establishing quality metrics.
- Participate in process improvement initiatives such as data management, trial management, investigational product management, etc.
- Keep abreast of the current global GxP/ICH regulations and industry best practices.
Preferred Experience and Education:
- BS/MS degree in scientific discipline.
- In-depth and hands-on knowledge of the current FDA, ICH, EMA, MHRA, and country-specific regulations and industry best practices regarding GMP, GLP, and GCP activities. Knowledge of global GVP regulations is a plus.
- Broad knowledge of risk-based quality systems approaches consistent with ICH E-6 guidances.
- Solid knowledge of the infrastructure and operational characteristics of non-clinical and clinical CROs and centralized services.
- Strong knowledge of root cause analysis tools and risk assessments.
- Strong knowledge of audit and qualification of CSPs.
- Broad knowledge of 21 CFR Part 11, 50, 54, 56, 312, and 314 including database, eCRF validation procedures, and eTMF requirements.
- Knowledge of drug development process, non-clinical and clinical development programs, end-to-end clinical trial processes as well as quality risk management and control tools.
- Working knowledge of CTA, IMPD, IND, and NDA submission and approval processes.
- Clinical Auditor certification is a plus.
- More than 7 years of relevant work experience in clinical operations and/or GCP/GLP QA roles within a pharmaceutical or biotechnology company.
- Experience with global clinical trials and global clinical trial requirements.
- Auditing experience across full range of audit types including non-clinical CROs, clinical CROs, supporting services, and laboratories etc. Experience with comuter systems validation (CSV) audit is a plus.
- Experience collaborating with non-clinical operations and clinical operations functions to develop and implement GLP and GCP QMS procedures.
- Demonstrated experience in interpretation/implementation of global, regional regulations, and industry best practices related to GMP, GLP, and GCP activities.
- Experience in risk-based quality systems approaches consistent with ICH E-6 guidances.
- Experience in inspection readiness and participation in regulatory GLP/GCP inspections.
- Experience in preparing GLP/GCP training materials and conducting training.
- Experienced in quality metrics creation is a plus.
- Experience in review of protocols, amendments, IB, ICF, study plans, CSR, and other relevant documents etc.
- Experience in review and approval of change controls, non-clinical and clinical operations SOPs, working instructions, quality agreements, quality investigations, root cause analysis, CAPA, and EC.
- Experience in source data verification and audit of eTMFs.
Preferred Additional Skills:
- Ability to build professional relationships with stakeholders and contract service providers.
- Ability to perform duties independently.
- Ability to manage multiple projects and tight timelines
- Excellent communication, technical writing, critical thinking, and analytical skills.
- Excellent organizational, prioritization, problem solving, and decision-making skills.
- Excellent collaborative, partnering, and interpersonal skills.
- Proficient with Microsoft Office MS Office (Excel, Word, PowerPoint), Adobe Acrobat, Clinical Trial Systems, and eQMS etc.
- Ability to travel as required by projects (10-25% of time, US and International).
Salary Range 165,000 – 184,000
The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.