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Senior Quality Assurance Manager, Global Compliance
2 months ago
We are seeking a highly experienced and skilled Director of Global Quality and Compliance Excellence to join our team at Allergan. As a key member of our organization, you will be responsible for leading our global quality and compliance efforts, ensuring that our products and services meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Lead Global Quality and Compliance Efforts: Develop and implement global quality and compliance strategies to ensure that our products and services meet regulatory requirements and industry standards.
- Conduct Regulatory Inspections and Audits: Lead preparedness for regulatory inspections and audits, ensuring that our sites are compliant with global standards and regulations.
- Provide Technical and Regulatory Guidance: Provide technical and regulatory guidance to compliance-related events across the network, including observations and significant events.
- Collaborate with Cross-Functional Teams: Collaborate with cross-functional teams to ensure that we achieve on-time compliance and quality deliverables, high customer value, and profitable results.
- Develop and Maintain Quality Culture: Develop and maintain a quality culture by closely collaborating with AbbVie Manufacturing Site leadership, Quality Lab leadership, global functional groups, and Third Party Manufacturers.
- Education: Bachelor's Degree in a relevant Life Science or other technical area required. Graduate degree desired.
- Experience: 10+ years of experience in Quality Assurance, Regulatory, Operations, or Technical Support in a pharmaceutical or medical device setting required. Experience working in a regulatory agency preferred; direct interaction with regulatory inspectors required.
- Leadership Background: Strong leadership background with an ability to make agile and decisive decisions.
- Technical Expertise: Comprehensive understanding of biological and/or pharmaceutical (sterile, biological, liquid, ointments, devices, solid tablets and caplets, suspensions, granulations, soft elastic capsules, gel caps, extended-release products, coating solutions, and/or active pharmaceutical ingredients), medical devices or combination products technologies.
- Communication Skills: Strong influential skills and ability to effectively operate in a fast-paced, complex organization, apply strong analytical problem-solving skills, and demonstrate strong interpersonal skills.
- Competitive Compensation: We offer a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.
- Opportunities for Growth: We offer opportunities for growth and development, including training and professional development programs.
- Diverse and Inclusive Work Environment: We are committed to creating a diverse and inclusive work environment that values and respects all employees.
