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 products. This is an individual contributor management-level role within a CDMO dependent Quality organization. It requires solid technical expertise in sterile pharmaceutical manufacturing, strong CDMO relationship management skills, and fluency in the regulatory expectations for clinical-stage parenteral products. The successful candidate will operate with a high degree of autonomy and will partner closely with CMC development, Regulatory Affairs, Clinical Supply Chain, and CDMO Quality and manufacturing teams. The Manager QA will report to the Director, CMC QA, based in The United States, while supporting and liaising with global functions at Rhythm.
Responsibilities and Duties- Serve as the quality contact for external manufacturing partners producing sterile drug products, establishing and maintaining quality oversight of clinical manufacturing activities.
- Manages clinical lot disposition for sterile drug product, including review of batch records, analytical results, and compliance with Regulatory Dossiers.
- 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).
- Provides QA oversight during technology transfer activities for new clinical products moving into CDMO sites.
- Monitors contract manufacturer performance through routine reviews, meetings, and quality metrics.
- 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.
- Provides QA support during CDMO audits, including participating in audit execution.
- Supports regulatory filings (e.g., Investigational New Drugs (INDs), Annual Reports, Stability Reports) by reviewing data, ensuring compliance with regulatory procedures.
Qualifications and SkillsRequired
- Bachelor's degree in a scientific discipline (Chemistry, Biology, Engineering, or related field)
- A minimum of 5 years of relevant experience in the pharmaceutical industry, with established Quality and Compliance knowledge in supporting manufacturing of sterile products.
- Demonstrated experience providing sponsor-side quality oversight of CDMOs for sterile drug products, including batch record review, batch disposition, deviation management, and quality governance.
- Working knowledge of aseptic processing, media fills, environmental monitoring, and sterility as applied in a CDMO model.
- Strong understanding of cGMP regulations including FDA CFR Parts 210/211, EU Annex 1, ICH Q7, Q8, Q9, and Q10.
- Detail oriented with strong organizational skills and the ability to manage multiple clinical programs and CDMO relationships simultaneously.
- Self-directed and comfortable with a high degree of autonomy in a small-time, high-accountability environment.
Preferred
- Experience with technology transfer of sterile Drug Products into new CDMO sites.
- Experience with lyophilized products, pre-filled syringes, or other complex sterile dosage forms; experience in peptides is a plus.
- ASQ Certified Quality Auditor (CQA) or similar.
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.
The expected salary range for this position is $110,000 - $165,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and company performance. This role may be eligible for benefits and other compensation such as restricted stock units.
