Quality Assurance Manager

Boston, MA
Full Time
Technical Operations
Mid Level
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 Quality Assurance (QA) 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 supporting manufacturing and distribution from a quality and compliance perspective, reviewing and releasing drug substance lots and generally enhancing and strengthening good manufacturing and distribution quality culture across the board.

The Manager QA will report to the Associate Director, QA CMC, based in The United States, while supporting and liaising with global functions at Rhythm.

Responsibilities and Duties
  • Accountable for oversight of the Drug Substance manufacturing process from a Quality perspective.
  • Performs batch disposition of Drug Substance.
  • Responsible for the review and approval of process validation documents, protocols and reports, Master Batch Records and Executed Batch Records at the Contract Development and Manufacturing Organization (CDMO).
  • Assists in the review and verification of process data assuring compliance with data integrity and traceability requirements as appropriate.
  • Supports regulatory filings (e.g., Investigational New Drugs (INDs), Annual Reports, Stability Reports) by reviewing data, ensuring compliance with regulatory procedures.
  • Identifies and implements process improvements to increase efficiency and effectiveness of the drug substance disposition processes.
  • Utilizes GMP-regulated quality management systems, including document control, change control, deviations/complaints, and corrective and preventative actions (CAPAs).
  • Facilitates the creation, review, and approval of relevant SOPs and work instructions relevant to CMC activities.

Qualifications and Skills
  • Bachelor’s degree in pharmaceutical life sciences i.e. Pharmacy, Industrial Pharmacy, Biotechnology, Biopharmaceutics, and equivalent.
  • A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in manufacturing and distributing Clinical and Commercial products; experience in peptides is a plus.
  • The candidate should have a good understanding of drug substance manufacturing and be able to partner effectively with development functions.
  • Strong working knowledge of relevant FDA, EU, ICH GMP regulations and guidelines with proficiency in interpreting and implementing GMPs in a practical manner.
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
  • Proficient in using Veeva eQMS and Veeva Vault Quality strongly preferred.
  • Proactive, decisive, and determined approach and ability to independently manage initiatives.

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


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.
 
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