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 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 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

Pay range for this position:  $98,100-$147,100

Our ranges are derived from several sources, and largely reliant on relevant industry market data. Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.