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Associate Director, Quality Assurance
2 months ago
Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. We recognize the courage it takes for patients and their caregivers to begin their journey of advocacy to find the answers they need. Their courage inspires us to challenge convention, ask bold questions and seek answers for them. Every day, we strive for excellence through our willingness to adapt, learn, and our tenacity to overcome barriers, together.
Opportunity Overview
Rhythm is looking for an Associate Director QA to play a leadership role in strengthening Rhythm’s Global Quality Management System being the subject matter expert for the learning and training management, documentation life cycle, Rhythm’s validated electronic system that houses all of Rhythm’s GxP records. The Associate Director QA will lead the Quality and Compliance governance and ensures that Rhythm and all its affiliates worldwide are working with a well connected and streamlined quality management systems. He/she works and liaises with the global team in establishing key metrices to define areas for continuous improvement and maintain a steadfast growth in Rhythm’s quality culture and compliance stance.
The Associate Director QA will report to the Head of QA GMP/GDP, based in The Netherlands, while working across global functions at Rhythm.
Responsibilities and Duties
- Manage Rhythm’s initial and continuous training and personnel qualification systems and processes
- Establish key Quality Performance metrices to identify areas for improvements in Rhythm’s Quality Management System (QMS) and report the state of Good Practice (GxP) compliance to management.
- Establish and maintain GxP procedures, policies, forms, and other controlled documents in Rhythm’s Quality Docs system
- Lead and Manage the Electronic Document Management System (EDMS) for all GxP controlled documentation.
- Be the primary contact for the Learning Management System (Absorb LMS) for all GxP related trainings.
- Oversee GMP/GDP/GxP internal and external audit program; develop a routine audit plan and communicate and follow up its status with relevant stakeholders.
- Point Person for Rhythm Product Complaint Management Program and ensure proper reconciliation against other relevant product safety and quality reporting systems
- Manage the electronic QMS (Veeva Vault) for Quality Events, Change Management, and Vendor Management modules.
- As needed, support Information Technology initiatives ensuring a compliant roll out and post-deployment maintenance of critical GxP IT systems
- Assist preparations for corporate and health authority inspection-readiness programs
- Serve as a subject matter expert (SME) for areas of responsibility during regulatory inspections, and directly manage inspection readiness activities.
- Support Quality Risk Management programs by overseeing global risk registers and risk mitigation initiatives within the Technical Operations team.
Qualifications and Skills
- Bachelor’s degree in pharmaceutical life sciences
- A minimum of 7 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge and expertise
- Working knowledge of current Good Manufacturing, Distribution, Clinical and Pharmacovigilance Practices, US and European Guidelines as related to the Pharmaceutical Industry
- Direct experience managing GxP systems (LMS, Veeva Vault)
- Experience in Audits, Risk Mitigation and Project management
- Experience in managing and hosting competent authority inspections
- Ability to work with highly diverse team in a remote working environment
This role is based out of our corporate office in Boston, Massachusetts. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston office in coordination with their department and business needs. This role may involve some travel.
More about Rhythm
Our lead asset, IMCIVREE® (setmelanotide), is a precision medicine designed to treat hyperphagia, an insatiable, pathological hunger characterized by abnormal food-seeking behaviors, and early- or rapid-onset severe obesity caused by an impairment of a pathway in the hypothalamus called the melanocortin-4 receptor (MC4R) pathway. IMCIVREE® is the first and only approved therapy for certain rare MC4R pathway diseases in the United States, Europe, Great Britain and several other countries. In collaboration with leading experts across the world, Rhythm is advancing the most comprehensive clinical research program ever initiated in MC4R pathway diseases, including a Phase 3 trial for acquired hypothalamic obesity. In addition, we are leveraging our extensive genetic database, global network of researchers, a track record of regulatory successes and global commercial infrastructure to develop a full portfolio of treatment options to patients struggling with hyperphagia and severe obesity and ensuring they get the treatment that is right for them.
We continue to advance care and precision medicines that address rare diseases. We are focused on expanding access to IMCIVREE® to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.
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