The Role
Manage day-to-day administration of Veeva QDocs/eQMS, support GxP document lifecycle and end-user troubleshooting, implement QMS improvements, assist complaint intake, coordinate training, participate in GxP IT system validation, perform supplier audits, and support inspection readiness to ensure GMP/GDP compliance for clinical and commercial products.
Summary Generated by Built In
Company Overview
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with rare genetic disorders of obesity. 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 biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. Working at Rhythm means that you are part of a team that’s passionate about transforming the lives of people living with rare genetic disorders of obesity. 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
Skills Required
- Bachelor's degree in Life Sciences, engineering, or related field
- Minimum of five (5) years relevant experience in the pharmaceutical industry with Quality and Compliance in manufacturing/distributing clinical and commercial products
- Working knowledge of electronic quality management systems, document management systems, and learning management systems
- Proficiency with Veeva eQMS / Veeva QualityDocs; experience with Veeva Vault
- Strong working knowledge of FDA, EU, and ICH GMP regulations and ability to interpret and implement GMPs
- Experience participating in validation efforts for GxP IT systems, including test script execution and change control support
- Experience performing supplier/vendor audits and managing vendor relationships
- Effective cross-functional communication and ability to collaborate across multiple functions and time zones
- Willingness and ability to travel domestically or internationally ~10-15%
- Willingness and ability to work from the Netherlands corporate office in coordination with department (hybrid model)
- Ability to independently learn new digital tools and support system administration and end-user troubleshooting
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The Company
What We Do
Rhythm is a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity. The company is leveraging the Rhythm Engine -- comprised of its TEMPO Registry, GO-ID genotyping study and Uncovering Rare Obesity program -- to improve the understanding, diagnosis and potentially the treatment of these disorders. For healthcare professionals, visit www.RareObesity.com for more information. For patients and caregivers, visit www.LEADforRareObesity.com for more information.
