Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns ...
New
Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns ...
New
Field Quality & Risk Management * Perform regular field walks to assess workmanship, materials, and compliance with QA/QC plans and manufacturer requirements. * Identify, document, and track quality ...
Field Quality & Risk Management * Perform regular field walks to assess workmanship, materials, and compliance with QA/QC plans and manufacturer requirements. * Identify, document, and track quality ...
... enterprise risk management, strengthen quality culture, and deliver sustained competitive advantage. What You Will Do: Develop and execute the quality vision and strategy for the Life Sciences ...
... enterprise risk management, strengthen quality culture, and deliver sustained competitive advantage. What You Will Do: Develop and execute the quality vision and strategy for the Life Sciences ...
Create initial redlines of compliance, quality, risk management, safety and contracts policies at direction of VP and managers in the department. * Assist with coordinating Enterprise Risk Management ...
Create initial redlines of compliance, quality, risk management, safety and contracts policies at direction of VP and managers in the department. * Assist with coordinating Enterprise Risk Management ...
Create initial redlines of compliance, quality, risk management, safety and contracts policies at direction of VP and managers in the department. * Assist with coordinating Enterprise Risk Management ...
Create initial redlines of compliance, quality, risk management, safety and contracts policies at direction of VP and managers in the department. * Assist with coordinating Enterprise Risk Management ...
Experience with batch disposition, release governance, quality risk escalation, and quality decision-making within regulated manufacturing operations Preferred Qualifications: * Demonstrated success ...
Experience with batch disposition, release governance, quality risk escalation, and quality decision-making within regulated manufacturing operations Preferred Qualifications: * Demonstrated success ...
Experience with batch disposition, release governance, quality risk escalation, and quality decision-making within regulated manufacturing operations Preferred Qualifications: * Demonstrated success ...
Experience with batch disposition, release governance, quality risk escalation, and quality decision-making within regulated manufacturing operations Preferred Qualifications: * Demonstrated success ...
This role serves as a the last line of defense to prevent errors, drive value, and mitigate risk ... Conducts marketing control and quality reviews throughout the marketing lifecycle. Extracts and ...
This role serves as a the last line of defense to prevent errors, drive value, and mitigate risk ... Conducts marketing control and quality reviews throughout the marketing lifecycle. Extracts and ...
Experience with batch disposition, release governance, quality risk escalation, and quality decision-making within regulated manufacturing operations Preferred Qualifications: * Demonstrated success ...
Experience with batch disposition, release governance, quality risk escalation, and quality decision-making within regulated manufacturing operations Preferred Qualifications: * Demonstrated success ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Director, Quality - New Product Development Lead
Conshohocken, PA · On-site
$211K - $240K/yr
Partners with CMC and clinical supply leaders to embed quality risk management early, align readiness milestones, and enable efficient progression toward commercialization. Sets partner / vendor ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Quick apply
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Senior Quality Engineer
Yocumtown, PA · On-site
$84K - $115K/yr
Own quality risk visibility and provide fact-based go, conditional-go, or no-go recommendations at program and production readiness reviews * Define quality deliverables, qualification tasks ...
Risk Management Quality Engineer, QA Engineer Risk Management
Murrysville, PA · On-site
$67K - $86K/yr
Risk Management Quality Engineer, QA Engineer Risk Management Duration: 12 months contract to start Location: Murrysville, PA Contract type: W2 contract Quality & Regulatory In this role, you have ...
Risk Management Quality Engineer, QA Engineer Risk Management
Murrysville, PA · On-site
$67K - $86K/yr
Risk Management Quality Engineer, QA Engineer Risk Management Duration: 12 months contract to start Location: Murrysville, PA Contract type: W2 contract Quality & Regulatory In this role, you have ...
Supplier Quality Engineer
Murrysville, PA · On-site
Accountable for Supplier quality risk assessment and mitigation. Assess and coordinate Supplier Change Requests.,Hiring for the Process validation remediation project for a period of 2 years ...
Supplier Quality Engineer
Murrysville, PA · On-site
Accountable for Supplier quality risk assessment and mitigation. Assess and coordinate Supplier Change Requests.,Hiring for the Process validation remediation project for a period of 2 years ...
Risk/Quality Specialist (RN) - Risk Management
Johnstown, PA · On-site
$90K/yr
Risk/Quality Specialist (RN) - Risk Management Job Type: Full-time | generally flexible to 7:30- 1600 or 0900-1730. No weekend shifts and no on call. Your experience matters Conemaugh Memorial ...
Risk/Quality Specialist (RN) - Risk Management
Johnstown, PA · On-site
$90K/yr
Risk/Quality Specialist (RN) - Risk Management Job Type: Full-time | generally flexible to 7:30- 1600 or 0900-1730. No weekend shifts and no on call. Your experience matters Conemaugh Memorial ...
Quality Risk information
What is the difference between Quality Risk vs Quality Assurance?
| Aspect | Quality Risk | Quality Assurance |
|---|---|---|
| Focus | Identifying and mitigating potential quality issues and risks in processes or products | Establishing and maintaining quality systems and procedures to ensure product quality |
| Activities | Risk assessments, risk mitigation plans, process controls | Audits, process validation, documentation, compliance checks |
| Credentials | Risk management certifications, quality management training | Quality assurance certifications, GMP training |
| Work Environment | Cross-functional teams, risk analysis meetings | Quality departments, compliance offices |
While Quality Risk focuses on proactively identifying and mitigating potential quality issues, Quality Assurance emphasizes establishing systems and procedures to ensure ongoing product quality. Both roles are essential in maintaining high standards but differ in their primary objectives and activities.
What cities in Pennsylvania are hiring for Quality Risk jobs?
Cities in Pennsylvania with the most Quality Risk job openings:
Associate Director, Development Quality - OSD
Conshohocken, PA • On-site
Scorpion Therapeutics •
51 - 200 employees51 - 200 employees
Other
Medical, Dental, Vision, Life, Retirement, PTO
Posted 2 days ago
New
Job description
Provides modality-focused development QA leadership for oral programs, ensuring phase-appropriate oversight, risk management, and compliant execution across internal teams and external partners. Owns program-level quality strategy, governance cadence, and readiness milestones; ensures development documentation is traceable and inspection-ready. Partners with CMC and clinical supply stakeholders on control strategy evolution, tech transfer readiness, and issue management.
Key Responsibilities- Program QA Leadership (Oral)
- Own quality strategy, governance cadence, and risk register for assigned oral programs; define and track readiness milestones
- Guide application of QMS processes (deviations/CAPA/change control) in development context and ensure timely closure
- Produce deliverables such as program quality plans, readiness trackers, and decision/action logs
- Partner Oversight & Inspection Readiness
- Oversee external vendors/CMOs supporting oral development activities; ensure governance and escalation pathways
- Maintain inspection-ready documentation, narratives, and evidence packages for program scope
- Produce deliverables such as vendor governance packs, audit readiness checklists, and inspection evidence indexes
- BS+ Life Sciences / Engineering (or related)
- 10-12 years QA experience with development-stage oversight
- Demonstrated cross-functional leadership and risk-based judgment
- Experience in pharmaceutical/biotech oral product development and clinical supply interfaces
- Experience with external development networks and inspection support
- Development QA governance, phase-appropriate oversight, and readiness milestone management
- Change management (impact assessment, stakeholder mapping, communications, training/SOP readiness, adoption measurement)
- Partner governance/performance management across CMOs/vendors; inspection readiness evidence discipline
- Cross-functional leadership, escalation, and executive-ready risk/decision communication
- Quality risk management, issue triage, and timely action closure
- Veeva Vault Quality (eQMS) proficiency
- Flexible paid time off, medical/dental/vision, life/disability insurance, and 401(k) offerings; supplemental voluntary benefits; mental health benefits via Employee Assistance Program.
About Scorpion Therapeutics
Sourced by ZipRecruiter
Company size
51 - 200 Employees
Headquarters location
Boston, MA, US
Year founded
2020