Document Control and Training Specialist

Join our team in a dynamic hybrid role, offering flexibility to work remotely and from our headquarters in Watertown, MA.

COMPANY OVERVIEW:

Disc Medicine is a clinical-stage biopharmaceutical company committed to discovering, developing, and commercializing novel treatments for patients who suffer from serious hematologic diseases. We are building a portfolio of innovative, first-in-class therapeutic candidates that aim to address a wide spectrum of hematologic diseases by targeting fundamental biological pathways of red blood cell biology, specifically heme biosynthesis and iron homeostasis. Disc Medicine values collaboration, professional development, and scientific integrity and promotes an inclusive company culture that empowers and inspires.

POSITION OVERVIEW:

Disc Medicine is hiring a new GxP Document Control & Training Specialist due to the fast growth of the company's portfolio. The successful candidate will be responsible for the GxP Document Management System and Training Program at Disc Medicine. This candidate should have great attention to detail and a Quality mindset. This candidate will work cross-functionally, therefore should have great interpersonal skills. The role requires both independent and collaborative work.

RESPONSIBILITIES:

• Manage GxP Documents and ensure training is assigned appropriately.
• Foster a Quality mindset around Good Documentation Practices.
• Lead routine activities for Document Change Requests and Training.
• Track, trend and present metrics to Leadership team.
• Assist with GxP electronic system validation efforts as appropriate.
• Assist with QMS and process improvements as appropriate.
• Foster a positive workplace culture that prioritizes collaboration, ensures accountability, and a commitment to continuous improvement

REQUIREMENTS:

• Bachelor's degree in a scientific discipline or equivalent experience.
• Minimum of 3 years of pharmaceutical industry experience in Quality Assurance or other relevant roles.
• Ability to build relationships and work collaboratively with individuals within the company.
• A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs.
• Strong attention to detail and proper use of tools for information processing and electronic systems.
• Knowledge in Microsoft Word, Adobe, Excel, Smartsheet and Starting Point.
• Knowledge of applicable GxP regulations strongly preferred (e.g., CFRs and ICH).
• Deep experience working with EDMS and EQMS preferred.

Disc Medicine is an equal-opportunity employer committed to providing all qualified candidates and employees equal opportunities. We offer comprehensive benefits and competitive compensation packages. The Company headquarters are in Watertown, MA, and we provide a flexible work environment.

Disc Medicine actively recruits individuals with an entrepreneurial spirit and a drive for excellence. Interested candidates should submit a cover letter and resume to be considered for current and future opportunities.