Senior Specialist, Quality Assurance - Hybrid

Job Description

This position reports to the Associate Director, Global Clinical Supplies Quality and is critical to maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. 

Responsibilities may include, but are not limited to: 

• Evaluation and disposition of clinical supply materials with the assurance that the materials were produced in conformance to all applicable policies/procedures of our Company and compliance with all governing regulations. 

• Coordinate and/or support the preparation of procedures, processes and quality improvements. 

• Assists in the coordination of significant quality events including fact finding, investigation, coordination of clinical quarantine and recovery actions. 

• Collaboration across cross-functional and business areas to ensure robust processing, continuous improvement and cross-functional team building.

• Completing projects to improve the performance of our processes, including continuous process improvements, investigation Corrective/Preventative Actions (CAPAs), and value capture projects that seek to improve outcomes, reduce cost, or lower our processing cycle times.

• Managing investigation, change request and project timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible.

• Actively using and championing the use of Lean Six Sigma (LSS) and our Company's Production System (PS) tools, both in problem-solving and day-to-day operational activities. 

Education: 

• Bachelor's degree with an appropriate scientific or engineering field.

Required Experience and Skills: 

• Minimum of 5 years experience in the pharmaceutical or equivalent industry Good Manufacturing Practice (GMP) related field including Technical, Engineering, Quality or Operations.

• Familiarity with batch disposition (release) activities.

• Background in quality control, quality assurance, auditing or regulatory affairs. 

• Effectiveness and creativity in approaching and solving technical problems.

• In-depth working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area. 

• Basic understanding of the use and maintenance for Microsoft applications (such as Excel, Outlook, Access).

• Evidence of leadership skills coupled with highly developed oral and written communication skills, i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. 

• Demonstrated teamwork skills.

• Attention to detail, flexibility and an awareness of production and quality control problems.

Preferred Skills:

• Ability to independently manage multiple priorities and projects.

• Ability to lead and support teams of a cross-functional and multi-level nature, including senior management representatives. 

• Demonstrated analytical and problem-solving skills.

• Knowledge of Lean Six Sigma and Project Management.

• Knowledge and competency in SAP (ERP/MES), Veeva, PowerPoint, Excel and Word.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Op