Director, Quality Systems & Compliance
4 days ago
New York
Job Description Director, Quality Systems & Compliance (Remote) About Immuneering 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. General Summary of Duties: 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. Specific Duties may include but not be limited to the following: • 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. Desired Skills and Qualifications • 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. Physical Demands/ Working Conditions The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. While extensive travel is not anticipated with this role, it is possible to perhaps up to 10% at times. Requires prolonged sitting, some bending, stooping, and stretching. Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. No significant lifting is associated with the role. Immuneering is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace where all employees are treated with fairness and respect. We do not discriminate on the basis of race, ethnicity, color, religion, gender, sexual orientation, age, disability, or any other legally protected status. Our hiring decisions and employment practices are based solely on qualifications, merit, and business needs. We encourage individuals from all backgrounds to apply and join us in our mission. Job Offers: Immuneering uses the Immuneering.com domain and email addresses for all official communications. If you received communication from any other domain, please consider it spam. Note to Recruitment Agencies: We appreciate your interest in finding talent for Immuneering but please be advised that we do not accept unsolicited resumes from recruitment agencies. All resumes submitted to Immuneering without a prior written agreement in place will be considered property of Immuneering, and no fee will be paid in the event of a hire. Thank you for your understanding.