About Immuneering: Immuneering is a clinical-stage oncology company outpacing cancer to help patients outlive their disease. Our lead product candidate, atebimetinib (IMM-1-104) is currently in a Phase 2a trial in patients with advanced solid tumors including pancreatic cancer. 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 more than 50+ 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:

The Sr Director, Quality Assurance is a strategic leadership role responsible for overseeing all aspects of Quality within the organization including the development, implementation, and management of GxP (cGMP, GCP, and GLP) quality systems. To accomplish this, the candidate should have a strong knowledge of relevant regulations and be able to work cross-functionally to ensure compliance of Immuneering’s ongoing development programs with local, state, federal, and international requirements. This position will be instrumental in developing a culture of quality, ensuring compliance with global regulatory requirements, driving continuous improvement in quality systems, and supporting the successful development, manufacturing, and commercialization of pharmaceutical products.

A successful candidate will be a highly collaborative individual with strong interpersonal skills and will be an exceptional team player.

Specific Duties, may include but not be limited to the following:

· Develop, implement, and maintain GxP compliant quality systems and processes to ensure compliance with FDA, EMA, ICH, and global competent authority regulations and industry guidance

· Lead quality audits, risk assessments, and investigations, ensuring timely resolution of quality issues.

· Work with the company’s external suppliers and contract organizations to ensure consistent quality and compliance.

· Prepare for and lead inspections by regulatory agencies and commercial partners, serving as the liaison between the Company and auditors, including reporting and follow-up to any finding

· Oversee qualification and validation plans, assure proper batch releases and disposition.

· Oversee resolution of any product concerns, including investigation, tracking and corrective action plans (CAPA)

· Provide quality input on contracts and serve as the point person for negotiation of quality agreements.

· Champion a culture of quality and continuous improvement across manufacturing and development operations.

Desired Skills and Qualifications

· Bachelor’s degree in biological sciences or related field, with at least 8 or more years experience in Quality Assurance or related fields within the pharmaceutical or biotechnology industry

· Extensive knowledge of GxP (GMP, GLP, and GCP) regulations and guidelines, including FDA, EMA, and ICH requirements

· Demonstrated leadership experience managing teams and complex projects.

· Proven track record of successful CMC submissions and approvals in the US and internationally.

· In-depth knowledge of FDA, EMA, and ICH guidelines, regulations, and processes related to CMC.

· Strong leadership, communication, and project management skills.

· Must be focused on working collaboratively and within our values of: Data rules, All-in, Own it (Accountable), Caring and Humble.

· Ability to work effectively in a collaborative, fast-paced environment.

Location: Remote or Hybrid, if you live near an Immuneering office, regular Meet Ups are available.

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 the ability to perform essential job functions with or without reasonable accommodation. No significant lifting is associated with the role.

While extensive travel is not anticipated with this role, it is possible to perhaps up to 15% 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.