Remote Senior Manager, Quality Operations

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

Job summary

Achieve Life Sciences, Inc. is seeking a Senior Manager, Quality Operations to lead batch review and release activities and manage quality events as we move from clinical development to commercialization.

You will partner with CDMOs and 3PLs on serialization, DSCSA compliance, and end-to-end product traceability, while maintaining inspection readiness and contributing to the Annual Product Review. This is a remote role for candidates across the continental United States.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 7+ years of GMP quality experience in biotech/pharma.
• Experience reviewing batch records, release docs, analyses and stability data.
• Experience with deviations, investigations, CAPAs and regulatory impact.
• Familiarity with CDMOs and external manufacturing partners.
• Understanding DSCSA serialization and EPCIS data exchange.
• Knowledge of FDA/EMA/ICH GMP guidance; GCP/GDP beneficial.

Responsibilities

• Execute Batch Review & Release Support: review batch records, CoAs/CoCs, data, and release documentation; coordinate with CDMOs.
• Review Quality Events & Investigations: intake, triage, and review deviations, CAPAs, and OOS events.
• Support Product Complaints & Quality Risk Management: participate in investigations and risk-based evaluations.
• Support the Transition to Commercial Quality Operations: implement processes for commercial launch with stakeholders and vendors.
• Support Serialization & End-to-End Product Traceability: work with CDMOs and 3PL on DSCSA serialization and data exchange.
• Manage External Quality Partnerships: monitor vendor performance and oversee documentation, events, and distribution issues.
• Maintain Inspection Readiness & Quality Reporting: ensure documentation quality and contribute to Annual Product Review.

Skills

GMP Quality Experience

Batch Records Review

Quality Events Investigations

CDMO Collaboration

DSCSA Serialization Knowledge

Regulatory Knowledge (FDA/EMA/ICH)

Documentation Discipline

Education

Bachelor’s degree in life sciences or related field

Job description

Achieve Life Sciences, Inc. is seeking a Senior Manager, Quality Operations to lead batch review and release activities and manage quality events as we move from clinical development to commercialization.

You will partner with CDMOs and 3PLs on serialization, DSCSA compliance, and end-to-end product traceability, while maintaining inspection readiness and contributing to the Annual Product Review. This is a remote role for candidates across the continental United States.