Manager, Quality Assurance (QA), Global QMS

Boston, MA
Full Time
Technical Operations
Manager/Supervisor
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 in Massachusetts.

 
Share

Apply for this position

Required*
Apply with Indeed
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

To comply with government Equal Employment Opportunity and/or Affirmative Action reporting regulations, we are requesting (but NOT requiring) that you enter this personal data. This information will not be used in connection with any employment decisions, and will be used solely as permitted by state and federal law. Your voluntary cooperation would be appreciated. Learn more.
Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 04/30/2026
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*