Manager, Quality Assurance
Rezolute, Inc.
2 months ago
Remote friendly (United States)
United States
Operations
Principle Duties And Responsibilities
- Review and approve Master Production Records from Contract Manufacturing Organizations (drug substance, drug product, finished drug product labeling/packaging, and external laboratory oversight).
- Review executed records and provide final product disposition for clinical trials, extended access, and commercial supply.
- Ensure products are manufactured, tested, stored, and distributed according to cGMPs and applicable regulations.
- Ensure timely disposition of drug substance, drug product, and finished drug product (including labeling/packaging); interact with CMOs and Qualified Persons for ex-US territory release.
- Participate in CMC team meetings.
- Review/approve cGMP methods, procedures, master records, executed records, reports, and protocols.
- Author/maintain quality systems SOPs and work instructions.
- Review/approve production batch records, certificates of analysis, client notifications, specifications, qualifications, investigations, deviations, CAPA, certificates of origin, and certificates of conformance.
- Provide quality assessments/approvals for change controls affecting clinical/commercial products, processes, labeling, or distribution.
- Review/approve clinical and commercial labeling & artwork.
- Provide technical and/or strategic quality support for site audits, pre-approval inspections, and routine GMP inspections.
- Support post-approval commitments, variations, and lifecycle management with QA Compliance, Regulatory Affairs, and CMC.
- Support Continuous Process Verification/Validation and commercial process monitoring.
- Support inspection readiness and responses to regulatory agency questions/commitments/post-marketing requirements.
Qualifications/Requirements
- Bachelor’s degree in a scientific discipline and 5–7 years of experience in a cGMP-regulated pharmaceutical/biotech environment.
- Strong knowledge of Quality Systems and cGMPs (FDA, EU, ICH) with ability to assess compliance risks.
- Ability to work independently and remotely; prioritize and problem-solve without daily direction.
- Strong verbal and technical writing skills; collaborative working style.
- Ability to anticipate/mitigate challenges using a risk-based problem-solving approach.
- Microsoft Office experience (preferred).
Preferred Experience, Special Skills And Knowledge
- Hands-on expertise with GMPs.
- Entrepreneurial, innovative, analytical, solution-minded approach.
- Proficiency with SharePoint, MS Word/Excel/PowerPoint, Adobe Acrobat, and Veeva.
Benefits
- Health Insurance (Medical/Dental/Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement
- Review and approve Master Production Records from Contract Manufacturing Organizations (drug substance, drug product, finished drug product labeling/packaging, and external laboratory oversight).
- Review executed records and provide final product disposition for clinical trials, extended access, and commercial supply.
- Ensure products are manufactured, tested, stored, and distributed according to cGMPs and applicable regulations.
- Ensure timely disposition of drug substance, drug product, and finished drug product (including labeling/packaging); interact with CMOs and Qualified Persons for ex-US territory release.
- Participate in CMC team meetings.
- Review/approve cGMP methods, procedures, master records, executed records, reports, and protocols.
- Author/maintain quality systems SOPs and work instructions.
- Review/approve production batch records, certificates of analysis, client notifications, specifications, qualifications, investigations, deviations, CAPA, certificates of origin, and certificates of conformance.
- Provide quality assessments/approvals for change controls affecting clinical/commercial products, processes, labeling, or distribution.
- Review/approve clinical and commercial labeling & artwork.
- Provide technical and/or strategic quality support for site audits, pre-approval inspections, and routine GMP inspections.
- Support post-approval commitments, variations, and lifecycle management with QA Compliance, Regulatory Affairs, and CMC.
- Support Continuous Process Verification/Validation and commercial process monitoring.
- Support inspection readiness and responses to regulatory agency questions/commitments/post-marketing requirements.
Qualifications/Requirements
- Bachelor’s degree in a scientific discipline and 5–7 years of experience in a cGMP-regulated pharmaceutical/biotech environment.
- Strong knowledge of Quality Systems and cGMPs (FDA, EU, ICH) with ability to assess compliance risks.
- Ability to work independently and remotely; prioritize and problem-solve without daily direction.
- Strong verbal and technical writing skills; collaborative working style.
- Ability to anticipate/mitigate challenges using a risk-based problem-solving approach.
- Microsoft Office experience (preferred).
Preferred Experience, Special Skills And Knowledge
- Hands-on expertise with GMPs.
- Entrepreneurial, innovative, analytical, solution-minded approach.
- Proficiency with SharePoint, MS Word/Excel/PowerPoint, Adobe Acrobat, and Veeva.
Benefits
- Health Insurance (Medical/Dental/Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement