Director, Quality Systems & Compliance

IMMUNEERING CORPORATION•San Diego, CA

2d•Remote

About The Position

Immuneering (Nasdaq: IMRX) is a clinical-stage oncology company developing medicines for broad populations of cancer patients. Our initial aim is to develop a universal-RAS therapy, an approach designed to include patients with solid tumors driven by any mutation in KRAS, NRAS, or HRAS. Our inclusive approach differentiates us from narrowly targeted precision therapies, which are limited to patients with tumors harboring select mutations. We are currently evaluating our lead product candidate, IMM-1-104, in a Phase 2/3 a clinical trial in patients with advanced solid tumors harboring RAS mutations. IMM-1-104 is being developed as a once-daily oral monotherapy that aims to achieve universal-RAS activity through deep cyclic inhibition of the MAPK pathway. Deep cyclic inhibition is a novel mechanism that aims to deprive tumor cells of the sustained proliferative signaling required for rapid growth, while sparing healthy cells through a cadenced, normalized level of signaling. This mechanism was engineered using our proprietary informatics-based discovery platform. Immuneering’s R&D team is based in a ~38,000 square foot lab and office facility in San Diego. The company also has offices in New York City and Cambridge, MA. Immuneering has grown to approximately 55+ employees, all working to apply their expertise, passion and creativity to improve the lives of people with serious diseases. Immuneering’s team works collaboratively and relentlessly, thinking across traditional boundaries to help shape the frontiers of drug development. Be an integral part of Immuneering by spearheading, growing and developing robust quality processes and procedures. Join a diverse and collaborative group and make a deep impact of moving science forward in a fun, hybrid work environment which celebrates innovative thinking and where your input will be respected and sought out as an expert in your field. This role can be remotely based with the ability to travel to our offices and meetings as needed. The Director of Quality Systems & Compliance will be responsible for developing, implementing, and maintaining robust GxP-compliant quality systems to support Immuneering’s major initiatives related to our drug discovery, clinical trials, filings, and ultimately to commercialization. A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player who embraces our mission, vision, and values.

Requirements

Minimum of a Bachelor’s degree in preferably life science (technology, biological science, pharmacy, nursing, or other health related discipline preferred) or equivalent qualification.
8+ years’ experience in Quality and has supported pharmaceutical development from early phase transitioning into a commercial stage environment.
The ability to establish congenial and productive working relationships.
Exceptional communication skills, both written and verbal, QA writing skills are paramount.
Capability to manage multiple workflows within a single day.
Ability to effectively work within cross-disciplinary teams.
Must be a self-starter, proactive, motivated, ambitious, scientifically curious, and collaborative with a humble demeanor.

Responsibilities

Serve as business owner for document and learning management systems which are maintained in an electronic quality management system (eQMS) for GxP activities.
Contribute to the development, implementation, and lifecycle management of GxP documents and training programs to ensure processes, systems, and content meet phase appropriate quality standards and business goals (e.g., Phase 3 requirements).
Author and maintain site policies, standard operating procedures (SOPs) for document control, training, quality events, Corrective and Preventive action (CAPA), change control, and risk management to support GxP compliance activities.
Ensure appropriate training requirements are defined in GxP job-specific roles and curriculum for company-wide matrix. Manage requirement updates, as applicable.
Administer learning management system via eQMS, curriculum creation, scheduling, reporting, and facilitate technical support guidance.
Ensure data integrity and compliance within all GxP electronic systems.
Partner with IT to ensure system upgrades, management, and business changes to eQMS are conducted in accordance with internal SOPs and external requirements.
Ensure compliance with legal and regulatory standards for document archival/retention.
Monitor and continuously improve system performance and inspection readiness, using metrics and analytics to proactively address risks, strengthen compliance, and enhance user experience.
Facilitate or support inspections by regulatory authorities and maintain a state of inspection readiness.
Participate in internal and external audits as needed.
Provide QA support for deviations, CAPAs, effectiveness checks, change controls, investigations (OOS/OOT), and risk assessments.
Lead investigation/CAPA triage meetings and collaborate with cross- functional groups to ensure timely resolution and metric compliance.
Support Quality Management Review Program by tracking and trending data for system performance and improvements.
Generate reports and dashboards to monitor GxP activity performance, compliance, and training effectiveness.
Act as a trusted advisor to internal teams, providing compliance guidance and facilitating timely resolution of quality issues.
Develop and maintain effective working relationships with stakeholder functions to achieve GxP compliance goals.
Exceptional attention to detail required.
Must be flexible and agile with the ability to pivot, to prioritize business needs.