Director of Quality and Compliance Excellence
7 days ago
We are seeking a highly experienced and skilled Director of 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 sites are prepared for regulatory inspections and audits.
Key Responsibilities- Lead Preparedness for Regulatory Inspections: Ensure that our sites are compliant with global standards and regulations, conduct mock audits, and coach site leadership on how to address opportunities identified.
- Coach Site Leadership and Employees: Provide guidance and support to site leadership and employees during external regulatory inspections and audits to ensure successful outcomes and regulatory approvals.
- Provide Strategic Input and Guidance: Offer consultation, guidance, and strategic input to site and global leadership teams on initiatives that enable them to set priorities, advance quality culture, and maintain sites in an inspection-ready state while sustaining compliance.
- Ensure Quality Elements for New Product Launches: Ensure the delivery of all quality elements needed to facilitate new product launches, including Third Party Manufacturers that provide products directly to distribution centers, or to Allergan domestic and international plants for further packaging and/or testing.
- Provide Technical and Regulatory Guidance: Provide technical and regulatory guidance to compliance-related events across the network, a key component of Allergan's overall compliance strategy.
- Collaborate with Quality Centers of Excellence: Collaborate with Quality Centers of Excellence in reviewing regulatory intelligence and assessing company vulnerabilities against regulatory agency inspection findings.
- Serve as a Key Stakeholder: Serve as a key stakeholder for cross-functional teams to ensure that we achieve on-time compliance and quality deliverables, high customer value, and profitable results.
- Bachelor's Degree in Relevant Life Science or Technical Area: Bachelor's Degree in relevant Life Science or other technical area required. Graduate degree desired. Advanced technical and analytical expertise required for problem resolution of technical, quality, product, and/or engineering related issues.
- 10+ Years of Experience in Quality Assurance, Regulatory, Operations, or Technical Support: 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.
- Strong Leadership Background: Strong leadership background with an ability to make agile and decisive decisions.
- Comprehensive Understanding of Biological and/or Pharmaceutical Technologies: 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.
- Strong Quality Assurance/Control, Manufacturing, Laboratory, Technical Support, Regulatory, and/or Validation Background: Strong quality assurance/control, manufacturing, laboratory, technical support, regulatory, and/or validation background is required.
- Ability to Navigate Global Structure: Ability to navigate global structure with various ways of working and provide consistent leadership when faced with obstacles to provide solutions that satisfy Corporate, Divisional, regional, and local objectives.
- 50-75% Travel Required: 50-75% travel required
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Hamilton, Ontario, Canada Allergan Full timeAbout the RoleWe 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...
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Hamilton, Ontario, Canada Allergan Full timeAbout the RoleWe 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...
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