Senior QA Manager
Senior QA Manager
Job Summary
Essential Duties and Responsibilities
Plan and deliver
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Build and maintain the detailed workstream plan, including milestones, dependencies, owners and critical path.
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Track progress against the plan and raise schedule risks early, with options.
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Maintain the deliverables register and a readiness view for the workstream.
Manage risks, decisions and actions
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Own the workstream risk, assumption, issue and dependency log. Drive mitigation and escalate to the Program Manager when needed.
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Maintain the action register, decision log and responsibility matrix for major activities and deliverables.
Run governance
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Lead the weekly workstream review and prepare escalations for the Core Team.
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Produce status reports, dashboards and steering committee material.
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Provide inputs for program-level reporting.
Bridge technical and program leadership
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Understand the scientific content well enough to judge whether risk assessments, testing and technical reports are on track and realistic.
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Raise concerns early and communicate trade-offs clearly to scientific and leadership audiences.
Coordinate across functions
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Work with MSAT, Quality, Regulatory, laboratories and manufacturing sites to keep work aligned and moving.
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Direct any project support or technical writing resources assigned to the workstream.
Sustain the work
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In the later phase of the term, prepare handoff and closeout so that ownership, process changes and run-state responsibilities are clear.Purpose of the Role
The Technical Workstream Project Manager partners with the Technical Workstream Lead to deliver the technical workstream of the Nitrosamine Control Program over a two-year term. The role connects MSAT's technical teams with the Program Manager, so that technical work stays on plan, risks surface early, and decisions are well informed. It requires a strong scientific foundation and proven project management discipline.
Key Responsibilities
Minimum Qualifications
• Degree in chemistry, pharmacy, pharmaceutical sciences or a related scientific discipline.
• 8+ years in pharmaceuticals or another regulated industry, including 5+ years managing
technical projects.
• Project management certification is required: PMP or PRINCE2 Practitioner.
• Working knowledge of quality and compliance expectations in a regulated environment.
• Proven ability to drive accountability across functions without direct authority.
• Excellent written and spoken English, and strong Excel and MS Office reporting skills.
• Ability to work EU business hours with regular US overlap.