Manager, Device Quality Assurance
About the position
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 products. This role ensures quality oversight of contract manufacturers involved in the production of combination products and sterile drug products and that all external manufacturing activities meet regulatory requirements, quality standards, and internal expectations. They will be a key team member of the Technical Operations GMP QA group. The individual will manage quality systems, review documentation from contract partners, and support issue resolution across the supply chain. This role reports into the Director, CMC Quality Assurance, based in The United States, while supporting and liaising with global functions at Rhythm.
Responsibilities
• Serve as the Quality contact for external manufacturing partners producing combination products and sterile drug products.
• Review and approve batch records, device history records, test results, and other quality documents from contract sites.
• Monitor contract manufacturer performance through routine reviews, meetings, and quality metrics.
• 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.
• 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.
Requirements
• Bachelor’s degree in engineering, science, or a related field.
• A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in supporting medical device development activities and manufacturing of sterile products; experience in peptides is a plus.
• Experience working with medical devices, including detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
• Strong Working knowledge of Risk Management (ISO 14971, FMEA), Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities.
• Experience working with contract manufacturers or development partners
• Ability to manage multiple priorities and work independently.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• 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.
Nice-to-haves
• experience in peptides is a plus.
Apply Now
Apply Now
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 products. This role ensures quality oversight of contract manufacturers involved in the production of combination products and sterile drug products and that all external manufacturing activities meet regulatory requirements, quality standards, and internal expectations. They will be a key team member of the Technical Operations GMP QA group. The individual will manage quality systems, review documentation from contract partners, and support issue resolution across the supply chain. This role reports into the Director, CMC Quality Assurance, based in The United States, while supporting and liaising with global functions at Rhythm.
Responsibilities
• Serve as the Quality contact for external manufacturing partners producing combination products and sterile drug products.
• Review and approve batch records, device history records, test results, and other quality documents from contract sites.
• Monitor contract manufacturer performance through routine reviews, meetings, and quality metrics.
• 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.
• 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.
Requirements
• Bachelor’s degree in engineering, science, or a related field.
• A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in supporting medical device development activities and manufacturing of sterile products; experience in peptides is a plus.
• Experience working with medical devices, including detailed knowledge of appropriate global medical device regulations, requirements and standards including 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, European Medical Device Directive (93/42/EEC), EU Medical Device Regulation, Canadian Medical Devices Regulation (SOR/98-282), etc.
• Strong Working knowledge of Risk Management (ISO 14971, FMEA), Acceptance activities, Non-Conformance, Production and Process Controls, and Process Validation activities.
• Experience working with contract manufacturers or development partners
• Ability to manage multiple priorities and work independently.
• Ability to collaborate effectively in a dynamic, cross-functional matrix environment.
• 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.
Nice-to-haves
• experience in peptides is a plus.
Apply Now
Apply Now