Sr. Investigator

Your Role

This position is responsible for assembling all individuals required for preparing / completing timely and thorough investigations, and actively participating in the preparation/approval of investigations.  Position ensures investigations are compliant with CFR, FDA and ICH Guidance, global regulatory expectations, and international cGMPs. 

Major Position Activities & Responsibilities:

• Supervise and lead site wide effort of designing, conducting, and writing investigations; provide guidance and direction to all departments regarding investigations and appropriate CAPA.
• Assemble individuals required for preparing / completing timely and thorough investigations, and actively participating in preparing investigations.
• Collaborate, in a hands on manner, and provide direction on investigations and technical issues at the Indianapolis facility and at contract manufacturing sites
• Handle/investigate product complaints.
• As needed, compile data and authors reports that are submitted to regulatory agencies in support of product licenses and applications
• Performs special projects and other duties as assigned.
• As a part of the employee’s job requirements, the employee may be required to handle wastes including hazardous wastes.  The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.

Scope:

• Primary responsibility is guiding all STPS investigations, to ensure compliance with regulatory expectations, ensure thoroughness, and ensure effective CAPA are implemented
• Functions as a key technical resource in the Quality Operations organization
• Responsible for notifying management of any quality issue that require notification of regulatory authorities, e.g. NDA Field Alert reports
• Responsible for supporting management during regulatory inspections, e.g. providing details and rationale of STPS investigations
• Responsible, as needed, to interact with Sigma-Tau and CMO Management in Quality Assurance, Regulatory Affairs, Scientific Affairs and Project Management
• Does not have any direct reports

Who You Are

Minimum Qualifications:

• Position requires Bachelor’s degree in biology, chemistry, pharmacy or life sciences with graduate level degree in science preferred
• Minimum 4 years pharmaceutical industry experience required, in a technical or Quality role, with previous experience in investigations and CAPA activities

Preferred Qualifications:

• Experience with sterile drug products and biopharmaceuticals preferred
• Experience with FDA, and EU GMPs, and ICH Guidance
• The position requires proven ability and skill in analyzing, understanding, and presenting technical data
• Experience in technical writing and communicating across organization functions and organizational levels is expected