Manager, Quality Assurance, Global QMS
Rhythm Pharmaceuticals · Amsterdam, Amsterdam ·
- Category
- QA
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 Manager, QA, Global QMS to play a key role in ensuring quality and regulation-based 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 Manager, QA, Global QMS will report to the Associate Director, QA who is based in the United States, while supporting and liaising with global functions at Rhythm.
Responsibilities and Duties
Qualifications and Skills
Additional Information
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 neuroendocrine 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.
At Rhythm our core values are:
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 Manager, QA, Global QMS to play a key role in ensuring quality and regulation-based 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 Manager, QA, Global QMS will report to the Associate Director, QA who is based in the United States, while supporting and liaising with global functions at Rhythm.
Responsibilities and Duties
- Serve as Business Administrator for Veeva QualityDocs (Veeva QDocs), supporting day-to-day administration of document workflows, metadata, user access, and document lifecycle activities.
- Support GxP document lifecycle activities from a document control perspective in Veeva QDocs, ensuring documents meet procedural and regulatory requirements.
- Serve as a shared point of contact for Veeva eQMS and Veeva QualityDocs (Veeva QDocs), providing end-user support and troubleshooting issues in coordination with the broader QA systems and documentation team to ensure seamless system utilization.
- Support the implementation of Quality System improvements, including process enhancements, system updates, and preparation of quality metrics to support oversight, trending, and continuous improvement.
- Support the QA Complaints lead in the intake and triage of product complaints, helping distinguish between patient inquiries, patient experiences, and potential technical product quality issues, as needed.
- Provide ancillary support for the coordination of training associated with procedural updates and onboarding requirements as required.
- Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed.
- Perform supplier audits, including scheduling, vendor management, report generation, etc.
- Support inspection readiness activities, as needed.
Qualifications and Skills
- Bachelor’s degree in Life Sciences, engineering, or related field.
- A minimum of five (5) years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in manufacturing and distributing Clinical and Commercial products.
- The candidate should have a good understanding of electronic quality management systems, document management systems, and learning management systems.
- Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and implementing GMPs in a practical manner.
- Effective communicator with the ability to collaborate across multiple functions and time zones.
- Proficient in the electronic Quality Management System and electronic Document Management Systems, experience in Veeva Vault is a plus.
- Proactive, decisive, and determined approach and ability to independently manage initiatives.
- Demonstrated ability to learn new digital tools and quality systems within minimal in-person support.
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.
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 neuroendocrine 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.
At Rhythm 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
- We value the unique contribution each individual brings to furthering our mission