Aseptic Product Quality Manager
AbbVie
6 months ago
On-site
North Chicago, IL
Operations
Responsibilities:
- Act as quality SME for aseptic manufacturing; support aseptic events for Eye Care Quality Assurance Third Party Manufactures (TPM) via hands-on assessments and investigation support.
- Drive implementation of aseptic best practices at TPM based on AbbVie standards and technological advancements.
- Promote improvements to proactively identify, quantify, prioritize, and mitigate aseptic risks; build collaborative relationships with internal sites, the aseptic global team, and cross-functional teams.
- Maintain primary quality leadership with management oversight to achieve on-time quality deliverables, high customer value, and profitable results (including quality/compliance aspects of product transfers and organization optimization).
- Perform final quality release of manufactured product lots prepared by Third Party Manufacturers.
- Recommend key decisions on product quality, compliance, and regulatory conformance for sterile/biological/liquid/solids/device products; elevate medium/high risk events to AbbVie management; ensure Quality/Technical Agreements commitments are fulfilled and facilitate resolution when not.
- Establish and maintain relationships and open communication with TPMs, AbbVie plants/affiliates, and functional groups to define roles/responsibilities, identify projects/issues, understand site quality/compliance/resource needs, and provide guidance on quality concerns.
- Communicate/negotiate with external quality organizations to maintain consistent quality and expectations while balancing compliance risk and agreed service costs; prioritize initiatives considering timelines, resources, and conflicting priorities.
- Interface with Quality Assurance audit team to develop audit/due diligence/inspection readiness plans; review observations/responses and maintain corrective action timelines; support quality audits, initial site approvals, and due diligence; lead pre-approval inspection readiness to ensure regulatory approvals without market-entry delays.
- Support QA elements for new product launches (including TPM products to distribution centers or to AbbVie domestic/international plants for packaging/testing); coordinate follow-up on compliant trend investigations (including adverse events); manage exception documents and CAPAs.
- Conduct management reviews with TPMs to address quality, operational, and organizational issues; review Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) for accuracy/completeness/timeliness and ensure trends are addressed.
Qualifications:
- Bachelor’s Degree in relevant Life Science or other technical discipline (or equivalent job experience).
- 7+ years combined experience: at least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development, or Consulting.
- Comprehensive knowledge of aseptic manufacturing and some biological and/or pharmaceutical technologies (e.g., sterile/biological products, liquids, ointments, devices, solids, suspensions, granulations, capsules/gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
- Strong analytical and problem-solving skills; urgency-driven, able to manage multiple complex tasks; positive interpersonal skills; ability to perform as leaders, team members, and individuals.
- Act as quality SME for aseptic manufacturing; support aseptic events for Eye Care Quality Assurance Third Party Manufactures (TPM) via hands-on assessments and investigation support.
- Drive implementation of aseptic best practices at TPM based on AbbVie standards and technological advancements.
- Promote improvements to proactively identify, quantify, prioritize, and mitigate aseptic risks; build collaborative relationships with internal sites, the aseptic global team, and cross-functional teams.
- Maintain primary quality leadership with management oversight to achieve on-time quality deliverables, high customer value, and profitable results (including quality/compliance aspects of product transfers and organization optimization).
- Perform final quality release of manufactured product lots prepared by Third Party Manufacturers.
- Recommend key decisions on product quality, compliance, and regulatory conformance for sterile/biological/liquid/solids/device products; elevate medium/high risk events to AbbVie management; ensure Quality/Technical Agreements commitments are fulfilled and facilitate resolution when not.
- Establish and maintain relationships and open communication with TPMs, AbbVie plants/affiliates, and functional groups to define roles/responsibilities, identify projects/issues, understand site quality/compliance/resource needs, and provide guidance on quality concerns.
- Communicate/negotiate with external quality organizations to maintain consistent quality and expectations while balancing compliance risk and agreed service costs; prioritize initiatives considering timelines, resources, and conflicting priorities.
- Interface with Quality Assurance audit team to develop audit/due diligence/inspection readiness plans; review observations/responses and maintain corrective action timelines; support quality audits, initial site approvals, and due diligence; lead pre-approval inspection readiness to ensure regulatory approvals without market-entry delays.
- Support QA elements for new product launches (including TPM products to distribution centers or to AbbVie domestic/international plants for packaging/testing); coordinate follow-up on compliant trend investigations (including adverse events); manage exception documents and CAPAs.
- Conduct management reviews with TPMs to address quality, operational, and organizational issues; review Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) for accuracy/completeness/timeliness and ensure trends are addressed.
Qualifications:
- Bachelor’s Degree in relevant Life Science or other technical discipline (or equivalent job experience).
- 7+ years combined experience: at least 5 years in Quality Assurance/Aseptic Manufacturing Operations Management; 3 years in Operations, Research and Development, or Consulting.
- Comprehensive knowledge of aseptic manufacturing and some biological and/or pharmaceutical technologies (e.g., sterile/biological products, liquids, ointments, devices, solids, suspensions, granulations, capsules/gel caps, extended release products, coating solutions, and/or active pharmaceutical ingredients).
- Strong analytical and problem-solving skills; urgency-driven, able to manage multiple complex tasks; positive interpersonal skills; ability to perform as leaders, team members, and individuals.