Director of QA
QABC.GEN.P5
Develop and implement QA policies, oversee all QA activities, lead major interactions with regulators, and allocate budget and resources for quality programs.
Develop and implement QA policies, oversee all QA activities, lead major interactions with regulators, and allocate budget and resources for quality programs.
The story of this role
Who does this work
A Quality Assurance professional in a biotechnology CDMO who seeks to ensure patient safety and product efficacy through rigorous standards and compliance monitoring.
The problem this role solves
- The external problem: Regulatory complexities and ensuring compliance with FDA/EMA standards in the biotechnology industry.
- The internal problem: The pressure to maintain high-quality standards while managing fast-paced development and manufacturing processes.
- Why it matters: The belief that every patient deserves safe and effective products, and that quality assurance is critical in fulfilling this responsibility.
The plan
- Implement comprehensive quality systems into product development activities.
- Monitor operations continuously to ensure adherence to quality standards.
- Conduct regular training sessions for personnel on compliance and best practices.
- Perform audits and inspections to verify compliance with regulatory requirements.
- Collaborate with cross-functional teams to identify and mitigate quality risks.
What's at stake
Facing regulatory penalties due to lapses in quality assurance processes. Experiencing product recalls that jeopardize patient safety and company reputation. Creating a disjointed approach to quality that leads to inefficiencies and compliance failures.
Success looks like
Achieving full compliance with FDA/EMA regulations with minimal non-conformities. Ensuring product launches are timely with zero recalls due to quality failures. Building a culture of quality that empowers all employees to prioritize safety and efficacy.
Summary
Develop and implement QA policies, oversee all QA activities, lead major interactions with regulators, and allocate budget and resources for quality programs.
Level — P5 — Expert Professional
Expert in field; key problem solver and project leader, authority in multiple areas
- Scope
- Multiple systems or a technical domain
- Autonomy
- Sets direction within the domain
- Complexity
- Novel, high-ambiguity problems; establishes the approach
- Impact
- Org / multi-team outcomes
- Decision rights
- Authority over a technical domain
- Leadership
- Leads cross-team technical initiatives
- Typical experience
- 8–12 yrs
Core outputs
No core outputs recorded yet.
Adjacent roles
Nearest roles by structural coordinates (level + taxonomy). Distance 0 → 1; each carries its 3-state match band. How coordinates work → · Compare side-by-side →
Componentsshow ▾
Responsibilities5
- Develop and implement QA policies, standards and strategic goals across multiple projects or sites.commonlevel
- Oversee all QA activities (including R&D and manufacturing QA sub-teams).commonlevel
- Lead major interactions with regulators (e.g. FDA meetings, inspection responses).commonlevel
- Allocate budget and resources for quality programs; champion a quality culture.commonlevel
- Integrate quality strategy with corporate objectives and business priorities.commonlevel
Tasks3
- Develop QA policies.commonlevel
- Oversee QA activities.commonlevel
- Lead regulatory interactions.commonlevel
Skills5
- Policy developmentcommonlevel
- QA oversightcommonlevel
- Regulatory interactioncommonlevel
- Resource allocationcommonlevel
- Strategic integrationcommonlevel
Knowledge5
- QA policy developmentcommonlevel
- Comprehensive QA oversightcommonlevel
- Regulatory engagementcommonlevel
- Budget managementcommonlevel
- Strategic quality integrationcommonlevel
competency4
- Visionary Thinkingcommonlevel
- Business acumencommonlevel
- Mentorshipcommonlevel
- Empowermentcommonlevel
qualification2
- ~12–15 years of broad quality assurance experiencecommonlevel
- Has led multiple teams or functions, managed large-scale compliance programscommonlevel
Title aliasesshow ▾
| Alias | Type | Confidence | Approved |
|---|---|---|---|
| Director of QA | common | medium0.50 | — |
Classification mappingsshow ▾
O*NET / SOC
- code=51-0000title=Production Occupationssource=inferred_from_superfunctionreviewStatus=needs_review