- Establish and maintain corporate quality systems, supportive policies and procedures that enable Disc Medicine to comply with GxP regulatory requirements and current regulatory expectations.
- Establish and maintain the electronic Quality Management System (eQMS), including documentation and training for all GXP areas.
- Establish and maintain GxP training for the company.
- Establish and maintain the GxP vendor management program, including auditing, performance monitoring, and inspection readiness (as applicable) for GxP vendors.
- Interface directly with Disc Medicine Leadership to assure cross-functional alignment of goals and objectives, ensuring GXP compliance and realization of systems-related best practices.
- Partner with IT to develop an E-Systems roadmap that allows for the growth and scaling of systems to ensure continued compliance and growth of our business.
- Partner with IT to establish and maintain the computer system validation program at Disc Medicine including computer system assessments, validation, and change management.
- Ensure that Disc Medicine is inspection-ready and serves as the host/co-host of regulatory inspections.
- Lead, manage, and develop a support staff of quality professionals.
- Support and foster an environment conducive to innovation, high productivity, and high quality.
- A bachelors degree or higher in Life Sciences/Chemistry or engineering, 10+ years of experience in the pharmaceutical/ biotech industry, at least 5 years in a Quality Systems role.
- Previous experience in GxP auditing and vendor management.
- Strong knowledge of cGMPs, FDA, EU GxP, and ICH regulations.
- Strong technology aptitude with hands-on experience in E-Systems- previous e-system administration experience is preferred.
- Exceptional organizational, interpersonal, and communication skills, both verbal and written, with the ability to facilitate meetings, conduct training, and present information in an advisory capacity.
- Attention to detail, excellent review skills, and the ability to organize and manage multiple tasks in a fast-paced environment.
- Able to travel (some international) up to 30%.
- Ability to work both independently and collaboratively with project teams and cross-functionally to build productive relationships with internal and external partners, influence decision-making, and engage in conflict resolution.
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Director of Quality Systems and Compliance - Watertown, United States - Disc Medicine
1 week ago
Description
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:
Reporting to the SVP of Quality, Disc Medicine is seeking an energetic and highly motivated Director of Quality Systems and Compliance who will be responsible for establishing and maintaining corporate quality systems, supportive policies, and procedures that enable the company to comply with GxP regulatory requirements and evolving regulatory expectations, while also helping enable a Quality Culture internal to the company.
This role will directly be responsible for ensuring that Disc Medicines Quality systems enable and facilitate compliance across all GxP areas of the company: GLP, GMP, GCP, and GVP. Systems will be established and scaled to support Disc Medicines pipeline needs, in a phase-appropriate manner (pre-clinical through commercial). Quality Systems within the scope of this role include but are not limited to, documentation management (Development and GxP scope), GxP training program, GxP vendor management (auditing and performance monitoring), and inspection readiness (internal and vendor). This person must be capable of formally/informally influencing, leading, and guiding both internal departments and external vendors through collaborative relationship building.
RESPONSIBILITIES:
REQUIREMENTS:
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 may apply through LinkedIn or via email by submitting a cover letter and resume to our Human Resources Department at and include the title of the position you are applying for in the subject line.
Please note that agency phone calls or submissions will not be accepted.
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