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Rhythm Pharmaceuticals Senior Manager, Quality Assurance in Amsterdam, Netherlands

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with hyperphagia (pathological, insatiable hunger) and severe obesity caused by rare MC4R pathway diseases. 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

Rhythm is a global, commercial-stage biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of hyperphagia and severe obesity due to rare melanocortin-4 receptor (MC4R) pathway diseases. This is a key biological pathway that regulates weight and hunger. A central element of Rhythm’s mission is to improve the understanding of these diseases and develop management strategies for patients who have no treatment options available to them. Rhythm was founded in 2008 and is based in Boston, MA. The company’s clinical development program is currently focused on several rare MC4R pathway diseases . For healthcare professionals, visit www.RareObesity.com for more information. For those who may be affected or would like to learn more, visit www.LEADforRareObesity.com for more information.

 

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