The Biologics Drug Substance Quality Assurance Specialist is Responsible for performing key Quality tasks in respect of Company products. Work in the External Manufacturing Quality Group within the Technical Operations department, which oversees contract manufacturing operations, as well as Internal Quality Systems. Reporting directly to the Associate Director of External Manufacturing Quality Assurance

Essential Functions/Responsibilities

The position is responsible for monitoring and supporting the quality performance of contract manufacturing organizations and material suppliers to all applicable GXP standards. Responsible for, but not limited to:

• Monitoring the daily operations at the Contract Manufacturer, performing batch review and disposition, reviewing and approving product complaints, deviations, Validation protocols, change controls and leading product related investigations.

• CMO Batch file review and associated lot Disposition activity.

• Ensuring compliance of all respective contract manufacturers to both internal Jazz requirements and country specific regulations

• Collaboration with all contract manufacturers, packagers and testing laboratories to resolve any quality issues.

• Contributing to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers, as required.

• Highlighting any risks associated with maintaining supply of commercial drug products to all markets.

• Conducting vendor audits and vendor site visits as required.

• Assisting in internal audits and regulatory agency inspections.

• Summarizing CMO Annual Product Quality Reviews and supporting regulatory submissions

• Assist with the generation of Jazz APQR (Annual Product Quality Review). 

• Maintaining product related Quality Technical Agreements (QTAs).

• Understanding new regulations and guidelines, as they apply to the company business and implement systems and procedures to incorporate these new regulations as appropriate.

• Review and approve moderated complexity deviations and associated corrective actions.

• Review and approve less complex validation documents.

• Support the generation of new, as well as improvement of, existing department SOPs. 

• Support delivery of projects. 

• Work with management to resolve project issues and resource constraints within the team. 

• Liaise with the internal and external stakeholders to resolve and clarify any point of issue. 

• Review and approve executed batch records and product testing records.

• Disposition lots.

• Review and approve moderated complexity deviations and associated corrective actions.

• Review and approve less complex validation documents.

• Partner with other departments/groups to problem-solve and address moderately complex issues.

• Collaborate in the continuous improvement of the QA processes, identifying opportunities and leading them up to the implementation.

• Represent QA in cross-functional project teams for moderately difficult projects.

• Participate in and facilitate regulatory inspection readiness.

• Coordinates and collaborates with other teams to meet organizational goals and work requirements.

• Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals.

• Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.

• Follows processes and operational policies in selecting methods and techniques for obtaining solutions; solves moderately complex problems and can identify viable and often innovative options.

• Uses analytical skills and judgment to recommend the "best" solution.

• Demonstrates success using compliance knowledge, creativity, and regulatory perspectives to solve problems, especially those associated with major and critical deviations.

• Maintain quality from cell banking through to production and post-release events (e.g., stability, product complaints).

Required Knowledge, Skills, and Abilities

• Strong knowledge of GMP and Regulatory Compliance as applicable to the Pharmaceutical/ Biotechnology Industry.

• Ability to understand and apply GMP regulations as they relate to manufacturing, QC analytical testing, and facility operations, deep knowledge of biologics drug substance manufacturing.

• Substantial experience working in or directly supporting manufacturing within a biologics drug substance manufacturing site.

• Experience with contract manufacturing is desirable.

• Significant experience (>5years) of commercial and/or late state clinical phase GMP manufacturing of biologics drug substance products

• Highly organized, with exceptional time management and prioritization.

• Excellent verbal and written communication skills.

Required/Preferred Education and Licenses

• Bachelor’s degree in pharmacy, chemistry, biotechnology, biochemistry, microbiology or a related discipline