Senior Manager, Quality Assurance

Rhythm Pharmaceuticals

Amsterdam, Netherlands

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.

Responsibilities and Duties

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.

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