Senior Manager, Quality Assurance​/Qualified Person

Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated 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.

Rhythm is seeking an experienced Clinical and Commercial Qualified Person (QP) who will play a key role in ensuring quality and regulatory compliance across the product lifecycle, including the manufacture, testing, certification, release, importation, distribution, and ongoing quality oversight of Investigational Medicinal Products (IMPs) used in global clinical trials and of commercial medicinal products supplied to patients.

The QP will serve as a key member of the Technical Operations GMP & GDP QA team and act as the QP named on Rhythm’s Manufacturer’s/Importer’s Authorization (MIA) responsible for certification and release of clinical trial materials and commercial medicinal products in accordance with Regulation (EU) No 536/2014, EU Directive 2001/83/EC, EU GMP Annex 16, applicable Marketing Authorizations and Clinical Trial Applications, and other applicable GMP and GDP requirements.

The role will provide quality oversight across clinical and commercial supply chains, including contract manufacturers, packaging and labeling organizations, testing laboratories, depots, warehouses, and distribution partners.

The QP will report to the Senior Director, Head of Quality Assurance GMP, GDP, RP & DP and collaborate closely with Clinical Operations, Commercial, Regulatory Affairs, CMC, Supply Chain, Pharmacovigilance, Medical Affairs, and external partners globally.

• Serve as the designated Qualified Person for certification of Investigational Medicinal Products (IMPs) for use in EU and UK clinical trials and commercial medicinal products for supply to authorized markets, as applicable, exercising statutory independence in product release decisions.
• Prepare, review, and sign QP Declarations (QPDs) for IMPs in support of Clinical Trial Applications and substantial modifications across global trial sites.
• Ensure each IMP batch has been manufactured, tested, packaged, labeled, stored, and distributed in accordance with EU GMP, applicable Clinical Trial Regulations, and approved Clinical Trial Applications.
• Ensure each commercial batch has been manufactured and tested in accordance with EU GMP, EU GMP Annex 16, the applicable Marketing Authorization, product specifications, and approved manufacturing and testing arrangements.
• Perform QP certification of clinical batches, placebo materials, and commercial finished product batches, as applicable.
• Maintain oversight of clinical and commercial supply chains from drug substance through manufacture, packaging, labeling, storage, distribution, return, recall, and destruction activities.
• Provide Quality and QP oversight for clinical development, commercialization, product launch, and routine commercial supply activities, and provide GMP and GDP guidance to cross‑functional stakeholders.
• Participate in investigations of deviations, complaints, temperature excursions, protocol‑related quality events, out‑of‑specification results, and CAPAs associated with clinical trial materials and commercial products.
• Assess product quality defects, market complaints, recalls, and other reportable quality events, supporting timely…