Manager/Associate Director, Quality Assurance
Are you looking for a role with impact?
Our Regulatory team is looking for someone who wants the opportunity to be part of a growing company and is ready for the new challenges that come with it. This role reports to, and will collaborate and partner with, the Vice President of Regulatory and Quality. This dynamic will create an amazing learning environment and exposure to all levels of our company’s evolution with a chance to influence and impact how we get things done.
Magenta Therapeutics is a company dedicated to addressing significant needs across all aspects of transplant medicine with a culture fueled by an amazing, passionate group of people committed to the idea of “patients first” and making a difference.
We started with an idea— Significant needs remain for patients living with autoimmune diseases, blood cancers, and rare genetic diseases. Bone marrow transplant is a potential cure for many, but its high risks, toxic side effects and complexity prevent many patients from being able to benefit. Magenta is working comprehensively to change the transplant journey for patients.
By pioneering an innovative portfolio of novel therapeutics designed to make the entire bone marrow transplant process more effective, safer and easier, we aim to unleash the full potential of bone marrow transplant for those living with a wide array of conditions such as multiple sclerosis, scleroderma, acute myeloid leukemia, myelodysplastic syndromes, inherited metabolic diseases, and sickle cell disease.
The people at Magenta are at the very core of our progress in pursuing this vision. Our roles don’t dictate our daily activities – every employee is empowered to make an impact, seize opportunity and to develop skills and expertise.
You are perfect for this role if you like and want to be responsible for:
- Implementation of Quality Systems and activities to support company and development of products to ensure compliance with regulations, to include overseeing contractors and providing day-to-day support for the Magenta GxP Quality System components such as vendor audits and qualification, training, change control, CAPA, and batch record review
- Collaborate with GxP functions to develop standard operating procedures, as well as processing and circulating for review and approval all SOPs, protocols and final reports
- Management of contract quality staff and identification of on-going resource needs in line with budgetary conditions
- Organizational support for writing regulatory submissions, tracking deliverables, loading and controlling final regulatory submission and source documents
- Collaborating cross functionally with all relevant areas to support corporate objectives
We would like you to bring the following with you:
- Degree in a biology or related discipline with 5 to 10 years of relevant experience in Quality Assurance/Systems from biotech/pharma environment.
- Breadth of knowledge across various functional disciplines to include GxP experience, Quality Systems and regulatory requirements.
- Experience in electronic systems development and use.
- Fundamental knowledge of WORD templates, Excel and various office software applications.
- In depth experience using electronic environments for documentation management.
- Strong analytical and organization skills; attention to detail required.
- Ability to prioritize competing activities
- Ability to provide solution minded approaches and flexibility to emerging challenges
- Abilty to appropriately balance priorities plus multitask against competing priorities
To be successful part of the Magenta Team, you must be:
- Driven. You will be focused on the achievement of Magentas mission and major corporate goals.
- Results-focused. Demonstrated record of exceeding stretch goals, and willing to bring creative problem-solving skills to challenges along the way.
- Entrepreneurial. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business.
- Intuitive. You will have a demonstrated ability to work in the “gray zone” and anticipate challenges before they arise.
- Process-oriented, yet flexible. You will appreciate and be able to create and drive process, and at the same time recognize when rules are meant to be bent.
- Transparent and Articulate. You will have the ability to communicate clearly and concisely with all stakeholders.
- Independent. You will be able to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across the company.
- A role model for the company’s cultural pillars; Courage Commitment & Excellence