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Company Overview
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 a Sr Manager QA to play a key role in ensuring quality and regulation-based compliance during the manufacture and distribution of Rhythm clinical and commercial products. He/she will be a key team member of the Technical Operations GMP and GDP QA group. His/her main activities include managing Rhythm Pharmaceuticals Quality Systems, ensuring appropriate level of oversight within the legal entity; supporting manufacturing and distribution from a quality and compliance perspective, reviewing and releasing clinical and commercial bulk product lots and finished product lots; and generally enhancing and strengthening good manufacturing and distribution quality culture across the board.
The Sr Mgr QA will report to the Senior Director GMP & GDP QA, based in The Netherlands, while supporting and liaising with global functions at Rhythm.
Responsibilities and Duties
Quality Systems Lead
Establish and maintain the Quality Systems of Rhythm Pharmaceuticals Netherlands BV for manufacturing, distribution and commercialization related activities
Creation, review and approval of relevant SOPs and work instructions relevant to GMP and GDP activities
Lead and coordinate personnel training, documentation management, records management of deviations, complaints and product events, CAPAs, change controls, qualification of suppliers and customers, etc. including trending and continuous improvement initiatives
Ensure day to day Quality operations, internal and external (i.e. 3PL, CMO) are executed in line with Rhythm Quality Management System
Establish and monitor Quality Systems KPIs for measuring and improving Quality Performance Indicators
Support the creation and revision of Artwork and material master data and safeguarding GMP/GDP information
Represent the company during health authority inspections, as applicable
QP/RP responsibilities - this role has the opportunity to be registered as a secondary QP/RP on the Rhythm Netherlands licenses and will have ad hoc responsibilities to support final batch certification and post-certification market release.
Qualifications and Skills
Master’s degree in pharmaceutical life sciences i.e. Pharmacy, Industrial Pharmacy, Biotechnology, Biopharmaceutics, and equivalent.
A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in manufacturing and distributing Clinical and Commercial products; experience in peptides is a plus
Up-to-date knowledge of current FDA and European Guidelines on Good Manufacturing and Distribution Practices, as related to the Pharmaceutical Industry
Eligibility to become a Qualified/Responsible Person in the European Union is preferred
Experience in managing external partners and customers remotely
Proactive, decisive and determined approach and ability to independently manage initiatives
Interpersonal communication and collaborative skills in dealing with a broad variety of cultures and teams
Fluency in English is a must and another European language is a plus
This role is based Amsterdam. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Amsterdam 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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