QA Operations - Specialist/Manager

Location
Cambridge, MA, United States
Posted
Feb 04, 2021
Ref
5066538002
Required Education
Bachelors Degree
Position Type
Full time
Magenta Therapeutics is a clinical-stage biotechnology company developing therapeutics to reset the immune system to cure more patients with devastating and life-threatening diseases. This immune reset approach can be realized through stem cell transplant for multiple diseases, including autoimmune diseases, blood cancers and genetic diseases.

Magenta's comprehensive approach to precision immune system reset will transform many aspects of the transplant process, aiming to make it safer and more effective. Our culture is fueled by a driven, passionate group of people committed to making a difference, seizing opportunities for maximum impact, and pursuing progress for the patients we seek to serve.

We are seeking a candidate to be an integral member of the Quality team and to provide oversight of various contract manufacturing organizations (CMOs) for drug substance, drug product and packaging/labeling operations. By establishing strong relationships with both internal and external partners, the candidate will independently manage projects, review and approve documents (protocols, reports, etc.) and coordinate batch release activities. The candidate is also responsible for support of general Quality System initiatives and Quality compliance.

You are perfect for this role if you are engaged by and want to be responsible for:
  • Review/approval of GxP documentation (SOPs, protocols, reports, batch records, change controls, etc.)
  • Release of GMP materials (drug substance and drug product) including review of relevant deviations and investigations
  • Review of QC release and stability data
  • Provide support for External manufacturing and testing operations at CMOs
  • Provide support for QMS / Document Control / Auditing activities
  • Collaborate cross functionally with all relevant areas of the company to support corporate objectives

We would be thrilled if you brought the following with you:
  • Bachelor's degree in a chemistry, biology or related discipline with a minimum of 4 years' relevant biotech/pharma GxP Quality experience
  • Experience with deviation investigations, OOS lab investigations, change control, CAPA development and process improvements
  • Breadth of knowledge across various functional disciplines to include small molecule/biologic drug substances and sterile drug products
  • Fundamental knowledge of US and EU GMP Regulations and relevant guidance documents (including ICH)
  • Proven ability to collaborate effectively with internal and external teams and able to function with minimal day to day oversight
  • Strong analytical and organization skills; attention to detail required
  • Strong Word and Excel skills a must; experience working with Sharepoint preferred
  • Ability to travel within the US and internationally up to 10-15%.

Successful leaders and contributors within Magenta are:
  • Driven. You will be focused on the achievement of Magenta's 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
  • Intuitive. You will enjoy learning and being involved in the content of our whole business, thriving on a very fast-paced and growing business
  • Collaborative. You will have demonstrated the ability to achieve objectives across complex projects and organizational structures
  • Process-oriented, yet flexible. You will appreciate and be able to create and drive process, while also recognizing when flexibility is needed.
  • 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

At Magenta, we celebrate our differences. We value the power of a diverse array of folks who bring all of themselves to their work. We embrace cultural, cognitive, social, and professional diversity because we know the only way we're going to make new cures possible is by working together.