company_site
Senior Manager, Quality Operations
Achieve Life Sciences
USA
Full-time
Senior · 7+ years experience
Onsite
USD 175000-190000 / year
Discovered 3 days ago
gcp
Key Skills for This Role
gcp
Full Job Posting
What You’ll Do
- Execute Batch Review & Release Support: Perform detailed technical reviews of executed batch records, Certificates of Analysis (CoAs), Certificates of Compliance (CoCs), laboratory data, stability results, and supporting release documentation. Identify discrepancies, missing information, and potential compliance concerns, and coordinate resolution with contract development and manufacturing organizations (CDMOs) to support timely batch disposition and release.
- Review Quality Events & Investigations: Conduct initial intake, triage, and review of deviations, investigations, corrective and preventive actions (CAPAs), and out-of-specification (OOS) events initiated by external manufacturing partners. Evaluate investigation documentation, assess potential product quality and compliance risks, monitor resolution timelines, and partner with CDMOs to support appropriate root cause analysis and corrective actions.
- Support Product Complaints & Quality Risk Management: Participate in product complaint investigations and help implement the processes, responsibilities, documentation, and workflows needed to manage complaints in a commercial environment. Apply risk-based judgment to evaluate potential impacts to product quality and patient safety, identify emerging concerns, and escalate issues appropriately.
- Support the Transition to Commercial Quality Operations: Partner with the Senior Director, Quality Systems, cross-functional stakeholders, and external vendors to implement the additional processes and controls required for commercial launch. Help translate clinical-stage quality practices into processes that support commercial manufacturing, product release, ongoing distribution, and post-approval requirements.
- Support Serialization & End-to-End Product Traceability: Partner with CDMOs and third-party logistics (3PL) providers to support Drug Supply Chain Security Act (DSCSA) serialization requirements and Electronic Product Code Information Services (EPCIS) data exchange. Help verify the accuracy and completeness of traceability data as product moves from manufacturer to distributor, supporting compliant distribution and the integrity of the pharmaceutical supply chain.
- Manage External Quality Partnerships: Serve as a day-to-day Quality Operations contact for CDMOs and the 3PL, following up on documentation, quality events, release requirements, and distribution issues. Monitor operational quality trends, support vendor performance reviews and qualification activities, and participate in Person-in-Plant oversight as needed.
- Maintain Inspection Readiness & Quality Reporting: Maintain complete, accurate, and inspection-ready documentation for activities within the role’s scope. Support Quality Operations metrics and continuous improvement initiatives and contribute to preparation of the Annual Product Review.
What You’ll Bring
- Bachelor’s degree in life sciences or a related field, or equivalent relevant industry experience.
- At least 7 years of GMP Quality Operations experience in the biotechnology or pharmaceutical industry, ideally spanning late-stage clinical development and commercial readiness.
- Hands-on experience reviewing batch records, release documentation, analytical results, and stability data, with a strong track record of identifying discrepancies and ensuring documentation accuracy.
- Experience reviewing deviations, investigations, CAPAs, or other quality events and evaluating their potential impact on product quality, regulatory compliance, and patient safety.
- Experience working with CDMOs or other external manufacturing partners and 3PLs in an outsourced pharmaceutical or biologics environment.
- Understanding of the additional quality and distribution requirements involved in transitioning from clinical supply to commercial product, including DSCSA serialization, EPCIS data exchange, and end-to-end product traceability.
- Knowledge of applicable GMP regulations and guidance, including FDA, EMA, and ICH requirements. Working knowledge of GCP and GDP is beneficial.
- Strong attention to detail and documentation discipline, with the ability to recognize inconsistencies, assess risk, and follow issues through resolution.
- A proactive, hands-on approach and the ability to work effectively in a lean organization, balancing routine execution with evolving commercial launch priorities.
- Clear communication and collaboration skills, including the ability to work productively with external partners, raise concerns constructively, and escalate issues when appropriate.
About Achieve Life Sciences
Biotechnology28 employeesFounded 1991
Public specialty pharmaceutical company developing cytisinicline for adults seeking treatment for nicotine dependence and smoking cessation.
Visit company websiteJobs and hiring trendsApply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at Achieve Life Sciences
Senior Director, Scientific Affairs & Medical Education
, USA
SeniorFull-time
Discovered 3 days agoView →
Senior Director, Scientific Affairs & Medical Education
, USA
Discovered 3 days agoFull-time
Executive Director, Area Sales
, USA
Discovered 3 days agoFull-time
Director, Field Analytics & Operations
, USA
Discovered 3 days agoFull-time
Senior Manager, Cost Accounting
, USA
Discovered 3 days agoFull-time
Director, HCP Marketing
, USA
Discovered 3 days agoFull-time
Director, Brand & Consumer Marketing
, USA
Discovered 3 days agoFull-time
Senior Director, Field Medical
, USA
Discovered 3 days agoFull-time
Director, Data Strategy and Operations
, USA
Discovered 1 months agoFull-time