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 full-time Sr. Director/VP of Quality to join our team. The Sr Dir/VP of Quality Assurance is responsible for leading and managing all DICE Therapeutics Quality Assurance (QA) programs, activities, and staff to ensure compliance with global laws, regulations and applicable guidance. The overall responsibility of this role is to design and execute strategic and tactical guidance for GxP (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)) compliance for DICE’s manufacturing, distribution, test laboratories and clinical trial activities. In addition, this role will have QA oversight for Computer System Validation (CSV) activities. This role will hold ultimate responsibility for product release and for managing QA resources to support QA activities. This role will be responsible for identifying GxP risks and recommending remediation plans as well as leading continuous quality improvement initiatives. Title will be commensurate with experience.
- Develop, implement, maintain, and communicate the Company’s quality strategy, risk mitigation, and program initiatives
· Provide leadership and strategic guidance, ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of Company operations, processes, and products
· Establish and direct the Quality team to work cross-functionally to ensure a quality mindset is carried through all aspects of company activities
· Assess and assure quality and regulatory compliance related to cGMPs, GCPs, pharmacovigilance, GLPs, and other related activities performed by employees and vendors
· Ensure the development and maintenance of GMP/GLP/GCP compliant processes which control the quality of DICE’s manufacturing, laboratory, and clinical trial activities
· Implement and maintain a fit for purpose quality management system (QMS) across the GxPs by directing and providing oversight and input into the relevant quality systems and standards including but not limited to: change control; documentation systems; quality procedures, standards, and policies; product complaints; quality system reporting; personnel training documentation and other related areas.
· Ensure the QMS has the appropriate level of rigor and controls to maintain compliance with applicable regulations and guidance
· Create and execute a plan for ensuring a state of inspection readiness and continuous improvement including:
o Creation and execution of a Master Audit Plan outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and document audits.
o Coordinate activities, lead interactions and serve as the host during regulatory health authority inspections and notified third-party audits
o Maintain an inspection-ready environment at all times through a robust, internal self-audit program and delivery of audit-readiness functional training
o Ensure the follow-up and closure of all corrective and preventive actions (CAPAs) from DICE’s led audits, regulatory health authority inspections and notified third-party audits
· Develop a process for identifying, adjudicating and remediating risks and/or compliance concerns/issues. Ensure rapid escalation of significant quality issues or concerns
· Oversee drafting, agreement, and execution of Quality Agreements with vendors and other third-party providers
· Support preparation of the quality components of global regulatory submissions and interact with QPs and vendor Quality functions, as needed
· Ensure the completion of scheduled third-party audits by internal QA staff or external contractors, including resolution of any findings
· Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution; provide suitable recommendations and facilitate continuous quality improvement while maintaining compliance
· Accountable for maintaining company and departmental SOPs, job descriptions, and training documentation that are current, relevant, and appropriate
· Partner with the Head of Clinical Operations to develop a long-range Clinical Quality Assurance strategy in support of the clinical pipeline
· Chair the Company Quality Management Team or similar established body and report any substantial issues or concerns to Company officers as appropriate
· Ensure the Company is kept current with all new quality-related regulatory requirements, and provide guidance to senior and operational management on the implications of any new or updated requirements
· Act as the subject matter expert (SME) for the acquisition or optimization of new or existing products, processes, techniques, procedures, or facilities/equipment to ensure compliance with quality criteria
· Provide regular updates and recommendations to the Company’s senior management team regarding the status of objectives, projects, and goals relative to quality compliance objectives
· Other duties as assigned by the manager
Preferred Experience and Education:
· Bachelor’s degree Life/Health Sciences; Master’s degree and/or Ph.D. a plus
· Minimum 15 years of leadership experience within a Quality and Product Development Organization
· 10+ years of Quality leadership/management experience in director or higher-level position.
· Small molecule drug development experience highly desirable
· Experience implementing quality and business process improvement initiatives in a global, discrete manufacturing environment.
· Prior experience establishing a quality organization preferred.
· Strong analytical and problem-solving skills possessing proven record on quality tools.
· Prefer hands-on experience implementing Quality initiatives and demonstrated understanding of GxP requirements, regulations, development processes, and regulatory inspection procedures.
· Experience in all phases of regulatory submissions and interactions; international experience desired.
· Experience with database management abilities.
· Experience with documentation systems and with document review and auditing.
· Excellent communication skills, team members that can work collaboratively with colleagues across all functions.
· Excellent analytical, presentation, writing, and computer skills are required.
· Comprehensive knowledge of current US and ex-US regulatory guidelines, is required.
· Demonstrate excellent leadership and communication skills.
· Demonstrate strong organizational skills, including the ability to prioritize personal workload.
· Extensive supervisory experience and ability to guide, train, supervise and prioritize workload of direct reports.
· Senior managerial experience in a fast-paced company environment is desirable.
· Ability to work well in a fast-paced environment.
· Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards
· Extensive experience handling health authority inspections required
· Experience in overseeing or participating in GCP audits; experience including external CRO, clinical/regulatory and document auditing desirable.
· Superior team leadership, communication, collaboration, and problem-solving skills