Quality Operations Lead: Batch Release (Remote)

Achieve Life Sciences, Inc.; Oregon; Hybrid; USD 175,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan

Employee Stock Purchase Plan

Life insurance

Short- and long-term disability

Paid time off and holidays

Job summary

Achieve Life Sciences, Inc. is seeking a seasoned Quality Operations professional to lead batch review and release, verify analytical data, and ensure compliance across late-stage development and commercial readiness.

You will coordinate with CDMOs, manage investigations, and support DSCSA serialization and end-to-end traceability. The role emphasizes risk-based decision making, collaboration with external partners, and maintaining inspection readiness for a commercial manufacturing environment.

Qualifications

• Bachelor's degree in life sciences or equivalent industry experience.
• 7+ years of GMP Quality Operations experience in biotech/pharma, including late-stage development to commercial readiness.
• Experience reviewing batch records, release documentation, analytical results, and stability data.

Responsibilities

• Perform batch review & release support, identify discrepancies, and coordinate with CDMOs for timely disposition.
• Review quality events, deviations, CAPAs, and investigations for product quality and compliance risk.
• Participate in product complaint investigations and support risk management processes in a commercial environment.
• Assist transitions to commercial quality operations, translating clinical quality practices for manufacturing release and distribution.
• Support DSCSA serialization and EPCIS data exchange for end-to-end traceability.
• Maintain inspection readiness and quality reporting, contributing to Annual Product Review.

Skills

GMP Quality Operations

Batch record review

Deviation investigations

CDMOs collaboration

DSCSA serialization knowledge

EPCIS data exchange

Risk assessment & quality systems

Education

Bachelor's degree in life sciences

Job description

Achieve Life Sciences, Inc. is seeking a seasoned Quality Operations professional to lead batch review and release, verify analytical data, and ensure compliance across late-stage development and commercial readiness.

You will coordinate with CDMOs, manage investigations, and support DSCSA serialization and end-to-end traceability. The role emphasizes risk-based decision making, collaboration with external partners, and maintaining inspection readiness for a commercial manufacturing environment.