Associate Director, Quality Assurance- Aseptic Fill
- Provides GMP expertise of aseptic drug product filling operations in a biologics facility
Provides direction for complex deviations and complaint investigations; Managing media deviations, CAPAs and Complaint handling and ensuring that quality related deviations, complaints are escalated, investigated and resolved.
Understanding and working knowledge of GMP compliance including knowledge of 21CFR210, 211, 820 and the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary use
- Primary quality lead for project activities and the team members to achieve on-time quality deliverables, high customer value, and profitable results.
- Develops and approves cGMP documents including, but not limited to, SOPs, batch records and specifications. Ensures process is efficient
- Leads or supports regulatory or client audits as Aseptic Media subject matter expert.
- Primary driver for the quality and compliance aspects of product transfers and organization optimization.
- Makes key decisions on product quality, compliance, and regulatory conformance issues for sterile, biological, liquid, solids, and/or device products and medium and high risk events to AbbVie management.
- Participates in the development of the global Product Quality Assurance strategy to support pharmaceutical, biologics, device and combination product: implements strategy.
- Functions as main Quality liaison between third party manufacturers and AbbVie Operations in support of commercial operations, new product introduce product transfers.
- Supports the regulatory filings and marketing authorization dossiers by developing and/or reviewing of chemistry, manufacturing, and controls documen Drug Master Files/Certificate of Suitability of Monographs of the European Pharmacopoeia documents.
- Performs final quality release of manufactured product lots for products and/or product lines prepared by Third Party Manufacturers.
- Medicinal products intended for or manufactured in the European Economic Area additionally require QP release.
- Supports development of the legal supply agreements, contractors,or letters of intent to ensure the appropriate quality,compliance; regulatory aspects a the products; services covered; manage the organizations actions within the legal boundaries of these documents.
- Ensures alignment of Quality & Technical Agreements with the legal contracts that the commitments of the quality technical agreements are being fulfill.
- Helps facilitate resolution in cases where they are not. Interfaces with the Quality Assurance audit team to develop audit plans, due diligence plans, inst readiness plans, review audit observations and responses, and maintain a corrective action plan timetable.
- Provides support for quality audits, initial site approvals and due diligence activities.
- Leads and manages pre-approval inspection readiness as related to the Third Party Manufacturer to ensure regulatory approvals are obtained, with no market entries.
- Leads and manages all Quality Assurance elements needed to facilitate new product launches including Third Party Manufacturer's that provide produc to distribution centers, or to AbbVie domestic and International plants for further packaging and/or testing.
- Ensures product launches are promptly completed after the regulatory filing approval for each country that is targeted to market the product to support s transition to commercial production.
- Coordinate activities to support follow-up on complaint trend investigations for non-medical and medical (adverse events).
- Supports the management of exception documents and Corrective and Preventive Actions.
- Completes management reviews with assigned Third Party Manufacturers that identify and address quality, operational, and organizational issues.
- Obtains and reviews summaries of the Annual Product Reviews (domestic) and Annual Product Quality Reports (EU) from the Third Party Manufacture' accuracy, completeness, timeliness, and trends are identified and addressed in an appropriate manner and maintain relationships and open communici TPM's, AbbVie plants, affiliates and other functional groups to clarify roles and responsibilities, identify potential issues and to obtain an in-depth under: the product to ensure quality and compliance.
- Communicates and negotiates with external quality organizations to maintain a consistent level of quality and expectations that will minimize compliant also balance the cost of operating to provide AbbVie
- Bachelor's Degree in Life Science or other technical discipline with 12+ years of applicable experience [or]
- A Masters/Advanced degree and 10+ years of experience
- At least 7 years of experience in Quality Assurance Operations Management [and] 4 years in Operations, Research and Development or Consulting.
- Knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies (sterile, biological, liquid, ointments, devices, solid tat caplets, suspensions, granulations, soft elastic capsules, gel caps, extended release products, coating solutions and/or active pharmaceutical ingredien
- Possesses knowledge and skill set to operate within an environment that requires a high degree of urgency, strong analytical and problem solving skills interpersonal skills, ability to manage multiple complex tasks simultaneously, and capable of performing as leaders, members, and individuals.
Key AbbVie Competencies:
- Builds strong relationships with peers and cross functionally with partners outside of the team to enable higher
- Learns fast, grasps the "essence" and can change the course quickly where indicated.
- Raises the bar and is never satisfied with the status quo.
- Creates a learning environment, open to suggestions and experimentation for improvement.
Embraces the ideas of others, nurtures innovation and manages innovation to reality.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled