Associate Director, Quality Assurance
AbbVie
5 hours ago
Remote friendly (Irvine, CA)
United States
Operations
Job Purpose
- Support global toxin quality strategy across Therapeutics and Aesthetics through compliance strategy, design, implementation, and continuous improvement.
- Develop, implement, and continuously enhance toxin quality strategy; partner with global and site stakeholders; advance quality standards for toxin-related activities.
Key Responsibilities
- Build relationships with toxin stakeholders to support strategic projects, operational improvements, and best-practice implementation in toxin quality, standards, and compliance.
- Define, advance, and communicate toxin quality standards aligned to organizational objectives and evolving regulatory requirements; integrate global quality systems across the toxin network.
- Support risk mitigation for inventory controls, biosafety, biosecurity, and regulatory compliance; address emerging risks proactively.
- Independently identify potential quality risks for inventory controls, biosafety, biosecurity, and regulatory compliance; drive continued process improvement.
- Implement a “Quality Beyond Compliance” approach by recommending and designing forward-looking toxin quality policies and procedures.
- Lead toxin quality governance, including development of process and procedure documents for the global toxin network and enterprise toxin policy requirements.
- Use critical thinking and negotiation to ensure enterprise-wide quality compliance and implement tailored solutions.
- Coordinate and support preparations for inspections and regulatory reviews; advocate for quality requirements and standards.
- Support CDC inspections of AbbVie’s SAT program, as needed.
Qualifications
- Bachelor’s degree (or equivalent) in a related science field.
- 8+ years pharmaceutical industry experience, including preferably 3+ years working with Select Agents and Toxins (SAT) and understanding of toxin processes/systems (preferably in quality/compliance roles).
- Sound knowledge of toxin research regulations and compliance requirements.
- Ability to build collaborative relationships and communicate across cultures.
- Demonstrated critical thinking; independently develop and implement strategic quality solutions for toxin research compliance.
- Leadership experience managing projects and/or teams; cross-functional execution.
- Experience supporting external regulatory inspections.
- Excellent written/oral communication, project management, influencing/persuasion, matrix management without authority, and collaboration/negotiation.
- Willingness to travel up to 20%.
- Support global toxin quality strategy across Therapeutics and Aesthetics through compliance strategy, design, implementation, and continuous improvement.
- Develop, implement, and continuously enhance toxin quality strategy; partner with global and site stakeholders; advance quality standards for toxin-related activities.
Key Responsibilities
- Build relationships with toxin stakeholders to support strategic projects, operational improvements, and best-practice implementation in toxin quality, standards, and compliance.
- Define, advance, and communicate toxin quality standards aligned to organizational objectives and evolving regulatory requirements; integrate global quality systems across the toxin network.
- Support risk mitigation for inventory controls, biosafety, biosecurity, and regulatory compliance; address emerging risks proactively.
- Independently identify potential quality risks for inventory controls, biosafety, biosecurity, and regulatory compliance; drive continued process improvement.
- Implement a “Quality Beyond Compliance” approach by recommending and designing forward-looking toxin quality policies and procedures.
- Lead toxin quality governance, including development of process and procedure documents for the global toxin network and enterprise toxin policy requirements.
- Use critical thinking and negotiation to ensure enterprise-wide quality compliance and implement tailored solutions.
- Coordinate and support preparations for inspections and regulatory reviews; advocate for quality requirements and standards.
- Support CDC inspections of AbbVie’s SAT program, as needed.
Qualifications
- Bachelor’s degree (or equivalent) in a related science field.
- 8+ years pharmaceutical industry experience, including preferably 3+ years working with Select Agents and Toxins (SAT) and understanding of toxin processes/systems (preferably in quality/compliance roles).
- Sound knowledge of toxin research regulations and compliance requirements.
- Ability to build collaborative relationships and communicate across cultures.
- Demonstrated critical thinking; independently develop and implement strategic quality solutions for toxin research compliance.
- Leadership experience managing projects and/or teams; cross-functional execution.
- Experience supporting external regulatory inspections.
- Excellent written/oral communication, project management, influencing/persuasion, matrix management without authority, and collaboration/negotiation.
- Willingness to travel up to 20%.