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Company Overview

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families. 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 in our Boston or Amsterdam office 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 Boston office, while supporting and liaising with global functions at Rhythm.

Responsibilities and Duties

+ Oversee daily execution of quality records in Rhythm’s electronic Quality Management System (Veeva eQMS), including change controls, deviations, CAPAs, complaints, audit records, and vendor management activities.

+ Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Rhythm’s eQMS (Veeva eQMS).

+ Serve as a point of contact for Veeva eQMS and Veeva Quality Docs (Veeva QDocs), providing end-user support and troubleshooting issues to ensure seamless system utilization in partnership with IT/Veeva system administrator(s).

+ Intake product complaints, triaging submissions to differentiate between patient inquiries, patient experiences, and technical product quality issues.

+ Ensure accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments.

+ Assign and manage GxP training via Rhythm’s Learning Management System, monitor compliance, and generate training completion reports, as needed.

+ Coordinate training linked to procedural updates and onboarding requirements.

+ Support GxP document lifecycle activities from a document control perspective in Veeva QDocs, ensuring documents meet procedural and regulatory requirements.

+ 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.

+ 5+ years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in manufacturing and distributing Clinical and Commercial products.

+ Demonstrated 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.

+ Proficient in the electronic Quality Management System and electronic Document Management Systems, experience in Veeva Vault is a plus.

+ Demonstrated ability and eagerness to learn new digital tools and quality systems within minimal in-person support.

+ Proactive, decisive, and determined approach and ability to independently manage initiatives.

+ Effective communicator with the ability to collaborate across multiple functions and time zones.

+ Able to travel approximately 10-15% domestic and/or international to support audits, supplier visits or corporate initiatives.

+ Able and willing to adjust working hours occasionally/as needed to support global teams and cross functional projects

This role is based in either our corporate office in Boston, Massachusetts or our international office in Amsterdam, Netherlands. Rhythm operates in a hybrid-work model. Candidates applying must be willing and able to be in the Boston or Amsterdam 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 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

Rhythm is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

Headquartered in Boston, Rhythm is proud to have been named one of the Top Places to Work (https://www.bostonglobe.com/magazine/top-places-work/2023/) in Massachusetts.

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