Remote Senior Manager, Quality Operations (Commercial)

Achieve Life Sciences, Inc.; United States; Remote; USD 175,000 - 190,000; Full time

Benefits offered by this job

Medical/dental/vision insurance

401(k) retirement plan

Stock purchase plan

Job summary

Achieve Life Sciences, Inc. seeks a Senior Manager, Quality Operations to lead batch review, release support, and quality event management as the company transitions from clinical development to commercialization.

You will partner with CDMOs and 3PLs to implement commercial quality systems, including serialization, traceability, and end-to-end product flow. Strong attention to detail and risk-based judgment are essential, with a focus on patient safety and regulatory compliance.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 7+ years of GMP quality experience in biotech/pharma, spanning late-stage development to commercial readiness.
• Hands-on experience reviewing batch records, release documentation, analytical results, and stability data.
• Experience evaluating deviations, investigations, CAPAs, or other quality events for impact on product quality and patient safety.

Responsibilities

• Execute batch review and release support with CDMO coordination.
• Review quality events, investigations, CAPAs, and OOS with external partners.
• Support product complaints investigations and risk-based escalation.
• Assist transition to commercial quality operations and scale-up processes.
• Support DSCSA serialization and EPCIS data exchange for traceability.
• Maintain inspection-ready documentation and contribute to Annual Product Review.

Skills

Batch review

Quality events

Product release

Serialization

External partnerships

Risk-based judgment

Inspection readiness

Attention to detail

Communication & collaboration

Education

Bachelor’s degree in life sciences

Job description

Achieve Life Sciences, Inc. seeks a Senior Manager, Quality Operations to lead batch review, release support, and quality event management as the company transitions from clinical development to commercialization.

You will partner with CDMOs and 3PLs to implement commercial quality systems, including serialization, traceability, and end-to-end product flow. Strong attention to detail and risk-based judgment are essential, with a focus on patient safety and regulatory compliance.