Principal Auditor, Supplier Quality

Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines - which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN - We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER - We work as one, respecting each voice and tapping into our unique strengths across teams-so we can solve problems in new ways.

Make it RIGHT - We hold ourselves to a high standard of excellence,fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT - We take pride in our day-to-day work, knowing the impact we make - taking on challenges big and small to improve patient health.

The role:

The Principal Auditor, Quality Supplier, is a member of the Quality Auditing Team reporting directly to the Sr Manager, Quality Supplier. He or she executes supplier qualification activities.

The responsibilities:

• Executes the supplier qualification process and leads requirement review completion initiatives, including supplier on-site audits (vendors of API, raw materials, components, and services which support pharmaceutical manufacturing).
• Responsible for ensuring Supplier Quality requirements are performed and processed in a timely manner (e.g., audits, supplier re-evaluations, quality agreement negotiation and implementation, risk assessment/mitigation, SCAR (supplier corrective action report), part/service approvals, supplier notices of change).
• Plans and develops audit assessment strategies and logistics. Reports on weaknesses, ineffective procedures, policy exceptions and discrepancies and recommends appropriate corrective actions.
• Evaluates supplier corrective and preventive action responses to audit findings for adequacy and effectiveness, including root cause and timeliness.
• Owns and manages new supplier requests.
• Leads periodic supplier requirement reviews by confirming and/or obtaining quality requirements. Obtains resolutions for areas identified as compliance issues.
• Interpret and execute policies and procedures that affect the organizational unit.
• Utilizes electronic systems for maintaining supplier quality records and the Approved Supplier List.
• Collaborates with Purchasing and Incoming Quality Control teams as needed to ensure supplier requirements are met.
• Interact with senior management and, as needed, serve as Supplier Quality subject matter expert during Client Audits, Internal Audits, and/or Regulatory Inspections.
• Collects, trends and reports supplier quality performance metrics to ensure supplier monitoring requirements are met.
• Delivers training to other team members, or Simtra associates, as required.

Desired qualifications:

• Bachelor's degree required; with preference for a Science or Engineering field.
• Minimum ten (10) years experience in Quality, Manufacturing, or Engineering (Supplier Quality functions preferred).
• Pharmaceutical, medical device, combination devices, and/or biologics industry experience highly preferred.
• Experience auditing manufacturing facilities, laboratories, and computerized system vendors.
• Experience in root cause analysis with quality tools, corrective and preventive action methods, data analysis and reporting.
• Experience with Quality Agreement negotiations is a plus.
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise and eQMS software (examples include: TrackWise, JDE, Veeva, etc.)
• Responsibilities require an estimated 35%-75% travel, including internationally. Flexibility for remote work while not performing supplier audits.
• Travel requirements could include routine on-site visits to Bloomington, IN or Halle, Germany to collaborate with Simtra team members.
• ASQ, ISO and/or RAB auditor accreditation.
• Knowledge of pharmaceutical regulations and international standards, e.g., ISO 13485, ISO 9001, FDA cGMP, Eudralex, other global aseptic manufacturing regulations.
• Business Acumen; knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her industry, business, and organization.
• Collaboration and Teamwork: Good communications, facilitation, coordination, and team skills.
• Project management skills managing multiple issues of moderate to high complexity relatively independently with minimal supervision/instructions. Multi-tasking skills in a demanding fast paced environment.
• Ability to manage the Quality relationship with assigned key suppliers/stakeholders - Competence in supporting on-site / off-site supplier quality development including coordination / management of resources.
• Superior written and oral communications skill sets.

Physical / Safety Requirements

• Duties require the ability to don Grade C gowning in order to enter classified areas.
• Duties may require overtime work, including nights and weekends.
• Use of hands and fingers to manipulate office equipment is required.
• Position requires sitting for long hours but may involve walking or standing for long periods of time.

In return, you'll be eligible for[1]:

• Day One Benefits
  
  
  
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    
    
    
    • Spouse Life Insurance
    • Child Life Insurance
    
    
    
    
  • Short and Long-Term Disability Insurance
  • 401(k) Retirement Savings Plan with Company Match
  • Time Off Program
    
    
    
    • Paid Holidays
    • Paid Time Off
    • Paid Parental Leave and more
    
    
    
    
  • Adoption Reimbursement Program
  • Education Assistance Program
  • Employee Assistance Program
  • Community and Volunteer Service Program
  • Employee Ownership Plan
  
  
  
  
• Additional Benefits
  
  
  
  • Voluntary Insurance Benefits
    
    
    
    • Vision Coverage
    • Accident
    • Critical Illness
    • Hospital Indemnity Insurance
    • Identity Theft Protection
    • Legal and more
    
    
    
    
  • Onsite Campus Amenities
    
    
    
    • Workout Facility
    • Cafeteria
    • Credit Union
    
    
    
    
  
  
  
  

[1] Current benefit offerings are in effect through 12/31/25

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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