Quality Assurance Specialist

Rhythm Pharmaceuticals, Inc; Amsterdam; Hybrid; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Rhythm Pharmaceuticals, Inc. is seeking a QA Specialist to ensure quality and regulatory compliance during manufacture and distribution of clinical and commercial products in the Netherlands.

You will be part of the Technical Operations, GMP and GDP QA Group, supporting batch release documentation and quality records. The role reports to the Senior Manager Quality Assurance / QP and collaborates with QPs, cross-functional teams, and external GMP partners to maintain inspection readiness and

Qualifikationen

• Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry or related field.
• Minimum 3 years in pharmaceutical QA, manufacturing, document control or GMP/GDP environment (or 2+ years with Master’s).
• Strong knowledge of GMP and GDP principles and batch documentation.

Aufgaben

• Coordinate batch release readiness and documentation for IMPs and commercial products.
• Compile batch records, ensure documentation availability and timely disposition.
• Perform initial quality checks of batch documentation for accuracy and traceability.
• Manage routing, review and filing of GMP/GDP docs in electronic systems.
• Serve as main contact for external partner requests and internal stakeholders.
• Track deviations, CAPAs, change controls, temperature excursions and other quality records.
• Maintain supplier qualification docs and records for vendor lifecycle.
• Support quality metrics and routine data summaries for batch release and QA processes.
• Assist with audit and regulatory inspection readiness; retrieve documents and maintain records.
• Identify gaps in documentation and escalate to QA or QP as needed.
• Contribute to continuous QA process improvements.

Kenntnisse

GMP compliance

GDP compliance

Documentation control

QA batch release support

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Pharmacy or Life Sciences

Tools

eQMS

EDMS

ERP systems

Microsoft Office

Jobbeschreibung

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.

Opportunity Overview

Rhythm is looking for a QA Specialist to play an important role in ensuring quality and regulatory compliance during the manufacture and distribution of Rhythm clinical and commercial products. They will be a key team member of the Technical Operations, GMP and GDP QA Group. Their main activities include managing the day-to-day administration of quality processes and records, ensuring operational excellence in GxP compliance, and maintaining a state of inspection readiness.

The QA Specialist will report to the Senior Manager Quality Assurance / Qualified Person (QP) and will work closely with all QPs and other colleagues across Technical Operations, Supply Chain, Regulatory Affairs, and external GMP and GDP partners.

Responsibilities and Duties

• Support QPs and RPs in coordinating batch release readiness, including preparing batch release documentation for Investigational Medicinal Products (IMPs) and commercial medicinal products.
• Compile batch-related records and supporting documents, verify that required documentation is available, and follow up on missing or incomplete information to ensure timely batch disposition.
• Perform administrative and initial quality checks of batch documentation for completeness, consistency, accuracy, traceability, and compliance with approved procedures.
• Coordinate the routing, review, approval workflow and filing of GMP and GDP documentation within electronic quality and document management systems.
• Serve as the main point of contact for coordinating day-to-day documentation requests from external partners and ensure effective distribution of the requests to the internal stakeholders in a timely manner.
• Coordinate the preparation, processing and tracking of deviations, CAPAs, change controls, temperature excursions and other quality records including follow-up on outstanding information, actions and due dates, with escalation to the responsible QA colleague or QP as appropriate.
• Assist with maintaining supplier and service-provider qualification documentation and records related to vendor qualification lifecycle.
• Support quality metrics, and routine data summaries for batch release, quality systems, and management review activities.
• Support audit and regulatory inspection readiness by retrieving documents and maintaining accurate and accessible records.
• Identify documentation gaps, inconsistencies, or potential compliance concerns and elevate them promptly to the responsible QA colleague or QP.
• Contribute to continuous improvement of QA processes and procedures.
• Perform other GMP and GDP quality support activities as assigned, in accordance with approved procedures and role-specific training.

Qualifications and Skills

• Bachelor’s degree or equivalent qualification in Pharmacy, Pharmaceutical Sciences, Life Sciences, Biotechnology, Chemistry, or a related discipline.
• A minimum of three (3) years relevant experience in pharmaceutical Quality Assurance, manufacturing, document control, or another regulated GMP or GDP environment or 2+ years with a Master’s/advanced degree.
• Good working knowledge of GMP and GDP principles; familiarity with pharmaceutical quality systems and batch documentation.
• Experience supporting document review, batch record administration, quality events, or batch release activities is an advantage.
• Strong attention to detail, with the ability to identify missing, inconsistent, or inaccurate information in controlled documentation.
• Good organizational and prioritization skills, with the ability to manage multiple records, deadlines, and follow-up actions.
• Ability to follow approved procedures, maintain data integrity and confidentiality, and escalated issues appropriately.
• Comfortable using Microsoft Office applications and electronic documents, quality, or enterprise systems; experience with eQMS, EDMS, or ERP systems is desirable.
• Clear written and verbal communication skills and the ability to collaborate effectively with QPs, RPs, cross-functional colleagues, and external partners.
• Fluency in English is required; additional European languages are advantageous.
• Must be legally authorized to work in the Netherlands without the need for current or future employer visa sponsorship.

Additional Information

• This position may require 10-15% domestic or international travel to support audits, supplier visits, or corporate initiatives.
• Candidates must be willing to adjust working hours occasionally to support global teams and cross-functional project needs.

This role is based out of our corporate office in the Netherlands. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Netherlands office in coordination with their department and business needs.

More About Rhythm

We are a dynamic and growing global team spanning more than a dozen countries. At Rhythm we are dedicated to transforming the lives of patients living with rare melanocortin-4 receptor (MC4R) pathway diseases by rapidly advancing care and precision medicines that address the root cause. Our team is passionate about expanding access to reach more patients and developing novel therapies for other rare neuroendocrine diseases, including congenital hyperinsulinism.

Our Core Values Are

• We are committed to advancing scientific understanding to improve patients’ lives
• We are inspired to tackle tough challenges and have the courage to ask bold questions
• We are eager to learn and adapt
• We believe collaboration and ownership are foundational for our success