Senior Manager, Quality Assurance

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.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Netherlands      Manufacturing and Logistics      Quality Assurance      Rhythm Pharmaceuticals     

© EuroJobsites 2024