Associate Director, CMC Quality Assurance

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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.

Essential Functions:

The Associate Director, CMC QA is a key member of the DICE QA organization. Reporting to Sr. Director/Head of QA, the Associate Director, CMC QA will provide quality oversight/support for the CMC activities related to Drug Substances (DS), Drug Products (DP), and analytical development including 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 stakeholders across the organization, but most significantly with CMC Development organization, including process chemistry, pharmaceutical development, analytical development, and supply chain colleagues.  You must be a self-starter, creative problem-solver and able to flex with a growing fast-paced environment.

Key accountabilities and responsibilities include:

  • Quality designee for Head of QA in CMC team and project meetings with Contract Service Providers (CSPs).
  • Serve as unblinded CMC QA lead for clinical trial samples and review documents related to unblinded activities.
  • Ensure compliance with applicable GxP regulations, ICH guidelines, DICE standards, and industry best practices.
  • Responsible for CMC QA activities and quality support for the development of DS and DP in early and late-stage clinical development through commercialization.
  • Responsible for CMC QA activities and quality support for the analytical method development and validations for release and stability testing, as applicable in early and late-stage clinical development through commercialization.
  • Responsible for CMC QA activities and quality support for the supply chain for clinical trial materials/IMPs.
  • Collaborate with CMC team and CSPs to ensure timely resolution of quality issues and completion of quality tasks.
  • Collaborate with CMC team to develop and establish phase appropriate procedures.
  • Review and approve DS and DP manufacturing, packaging, and labeling batch records to ensure compliance with specifications, regulations, DICE standards, and quality agreement with CSPs.
  • Review and approve SOPs, change controls, specifications, certificate of analyses (CoA), labeling components, protocols, and reports.
  • Review and approve deviations and non-conformances investigations, and Corrective and Preventive Actions (CAPA).
  • Disposition of DS, in-process materials, packaging materials, labeling components, and DP as applicable.
  • Assist Head of QA in conducting audits of CSPs (CMOs, CDMOs, CROs, Contract Laboratories, Contract Packagers etc.) and establishing quality agreements.
  • Escalate quality and compliance issues to Sr. Director, QA/Head of QA.
  • Work closely with cross-functional teams to meet the project time lines and deliverables.
  • Identify opportunities for CMC processes/systems improvements.
  • Keep abreast of the current GxP, ICH guidelines, and industrial practices as pertains to early and late-stage clinical development through commercialization.
  • Back-up for other QA functional area activities.
  • Any other duties at the discretion of Head of QA.

Preferred Experience and Education:

  • PhD degree in scientific discipline with more than 5 years in a GxP pharmaceutical environment or BS/MS degree with more than 12 years in a GxP pharmaceutical environment.
  • Minimum of 2 years of management experience for PhD degree and minimum of 4 years of management experience for BS/MS level in relevant field.
  • Experience in managing CMC QA activities and support for early and late-stage clinical development through commercialization programs.
  • Experience in CMC QA activities with small molecules and solid oral dosage forms from early and late-stage clinical development through commercialization is preferred.
  • Experience working with CMOs, CDMOs, CROs, Contract Laboratories, Contract Packagers.
  • Experience working with QPs is preferred.
  • In-depth knowledge of GxP, ICH, and regional regulatory requirements from early and late-stage clinical development through commercialization of new drug products.
  • Knowledge of regional compliance and regulatory requirements for packaging, labeling, and shipping of clinical trial materials /IMPs.
  • Knowledge of drug substance and drug product development, manufacturing, packaging, scale-up, laboratory operations, and quality control from early and late-stage clinical development through commercialization.
  • Experience in review and approval of SOPs, change controls, quality investigations, CAPAs, root cause analysis, specifications, batch records, labeling components, analytical data, various types of protocols and reports.
  • Experience in vendor qualification audits and quality agreements.
  • Experience participating in regulatory audits.
  • Working knowledge of IND, CTA, IMPD, and NDA submission and approval processes.
  • Working knowledge of eQMS, MS Office (Excel, Word, PowerPoint) and Adobe Acrobat
  • 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, and analytical skills.
  • Excellent organizational, prioritization, problem solving, and decision-making skills.
  • Ability to travel as required by projects (10-25% of time, US and International).

Salary Range: $180,000 – $190,000

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.

DISCLAIMER

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.

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