Overview

Work Location: US Headquarters, Waltham, MA (3 Days / Week in Office)

About the Role

Cancer doesn’t care how it disrupts the course of lives. We do. Since our founding, we have pursued one goal: develop targeted cancer therapies to improve outcomes for cancer patients. This singular focus has positioned us as a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer. At ImmunoGen, each of us is driven by a shared conviction that by advancing precise, targeted cancer therapies, we have the power to offer more good days to patients and their families — now. It is why we come to work each and every day, and it is what will continue to motivate and energize us in the years to come. ImmunoGen is currently looking for an individual to join our Quality Team, willing to work in close collaboration with the Clinical, Regulatory, Translational Science, and Pharmacovigilance departments to ensure compliance with Good Clinical Practice(s), and other applicable regulations. This position is responsible for the assessing compliance of the company as well as that of company vendors/CROs/clinical sites.

Responsibilities

• Conduct or facilitate internal and external audits, including clinical site, vendor/CRO, Trial Master File, and internal process audits, as needed.
• Oversee vendor performance and deliverables
• Perform a quality assurance review of documents and data intended for regulatory submission.
• Ensure internal and external (clinical sites/vendors/CROs) adherence to GCP, GLP, and applicable regulations.
• Assist in the writing and/or reviewing of SOPs for the GCP compliance program, quality documentation such as quality agreements
• Perform quality assurance and GCP compliance review of various clinical study documentation such as study protocols, ICFs, monitoring plans, clinical study reports, etc.
• Manage deviations and CAPAs through completion.
• Assist in the development, tracking, and reporting of quality metrics.
• Assist in evaluating and investigating clinical study non-compliance, quality events, quality queries, and complaints.
• Communicate any critical compliance risks noted from these activities to QA management.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.

Life at ImmunoGenAt ImmunoGen, we are looking for forward-thinking talent with diverse experiences and a track record of success, leadership skills, a demonstrated ability to take initiative, and a passion for improving the lives of those living with cancer. To succeed here is to care — care about what we do, why we do it, and each other. We are working hard to bring hope to our patients and their families, which inspires our teams to aim high and honor our commitment to continuous improvement.At ImmunoGen, collaboration is not a construct. It is at the core of everything we do and shows up in how we work every day. Here, your ideas and experience matter. We value driven individuals who thrive in a fast-paced environment; who can think about our future and see the promise before us; who anticipate risks and opportunities; who are willing to learn and adapt to change; who are inclusive and eager.Together, we rise to the challenge before us, advancing our programs on the strength of our deep scientific and commercial expertise and energized by the opportunity to change long-standing treatment paradigms. We pride ourselves on the work that we do, and know that it is a privilege to work in the oncology space and to dedicate our days to helping patients.Our Unique OpportunityIt’s an exciting time for our organization. The US FDA recently granted accelerated approval for ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer, marking our transition into a fully-integrated oncology company. This is just the beginning, as we embark on an exciting new chapter as a leader in the development and commercialization of innovative oncology products.Joining ImmunoGen now will give you the unique opportunity to create a lasting impact — to make your mark on the work that we are doing by leveraging your experience to shape our first commercial launch and the go-forward organization.

Qualifications

Basic Qualifications

• BS/BA in the field of science such as chemistry, microbiology, biology and biochemistry or BS in a related science field such as Regulatory Science.
• Three - five years in a GCP environment with at least three years working in a role supporting GCP compliance.
• Experience in site monitoring, inspection readiness or leading and conducting clinical site, vendor/CRO, and internal process audits.
• Practical knowledge of GCP guidance and regulations and FDA inspection process.
• Proficient in Microsoft Office suite (Word, Excel, Powerpoint).
• Proven ability to identify and effectively resolve quality issues and gaps; a practical approach to problem solving.
• Experience with CRO management oversight or experience at a clinical trial site preferred.
• Ability to work independently and within a group setting and to interact effectively with internal customers, including Clinical, Medical and Pharmacovigilance functions.
• Strong communication skills (oral, written, and interpersonal) including the ability to give training in aspects of GCP compliance.
• Excellent attention to detail, time management, and investigative skills as well as the ability to manage multiple priorities.
• Demonstrates good judgment and decision-making experience.
• Demonstrates flexibility in dealing with change and diversity.
• Relationship-building skills.

Our BenefitsWe believe in the potential of our people and foster a supportive environment that develops our folks, rewards performance, and incentivizes long-term success. From excellent benefits and competitive compensation to ownership in the company, we want to inspire our employees.Our benefits include, but are not limited to:

• Competitive salary and bonus plans
• Top-tier health, vision, dental, and life insurance
• Generous paid holidays, time off, and parental leave
• Comprehensive package of benefits plans
• 401K Retirement Savings plan offering a company matching contribution
• New hire and annual restricted stock unit and stock option awards for all employees
• Tuition reimbursement
• 3:2 office workday for flexible working arrangements
• Stipends for learning opportunities

About ImmunoGenImmunoGen is developing the next generation of antibody-drug conjugates (ADCs) to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to TARGET A BETTER NOW™. Learn more about who we are, what we do, and how we do it at www.immunogen.com.

At ImmunoGen, targeting a better life for people with cancer is what we do, and we believe that a diverse and inclusive team is essential to achieving this. We strive to create a workplace that reflects the communities we serve and where everyone feels empowered to bring their full, authentic selves to work. There is work to be done and with the help of our entire team — our employees, customers, partners, and community — we can deliver more good days to those who need them most.

ImmunoGen is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

ImmunoGen does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on ImmunoGen’s approved agency list. Unsolicited resumes or candidate information submitted to ImmunoGen by search/recruiting agencies not already on ImmunoGen’s approved agency list shall become the property of ImmunoGen and if the candidate is subsequently hired by ImmunoGen, ImmunoGen shall not owe any fee to the submitting agency.

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