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SeniorFull-timeAPI
Salary Range
$66,300 - $89,700 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are seeking a Quality Assurance Manager to ensure the quality of pharmaceutical products, including small molecules, biologics, combination products, and medical devices. This role will support AbbVie's business objectives by maintaining compliance with policies and regulations worldwide.
Key Responsibilities
- →Maintain the primary quality lead for project Quality activities and team members to achieve on-time quality deliverables
- →Develop and implement global Product Quality Assurance strategy for pharmaceuticals, biologics, and devices
- →Make key decisions on product quality and compliance issues and elevate medium and high risk events to management
- →Establish and maintain relationships with Third Party Manufacturers, AbbVie plants, and other functional groups
- →Communicate and negotiate with external companies' quality organizations to maintain quality standards
- →Interface with Quality Assurance audit team to develop audit plans and inspection readiness plans
- →Manage Quality Assurance elements for new product launches and facilitate new product transfers
- →Support the management of exception documents and Corrective and Preventive Actions
- →Develop product quality transfer process monitoring metrics and manage quality teams
Requirements
- ✓Experience in Quality Assurance and Regulatory Affairs
- ✓Strong understanding of pharmaceutical and biologic product quality standards
- ✓Knowledge of compliance and regulatory requirements
- ✓Ability to lead and manage quality teams and projects
- ✓Excellent communication and negotiation skills
- ✓Experience with Third Party Manufacturers and supply chain management
- ✓Ability to prioritize programs and initiatives effectively
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