Principal Quality Auditor

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.

This role:

The Principal Quality Auditor is a member of the Quality Assurance Team reporting directly to the Sr Manager, Quality Auditing. They conduct internal audits ensuring compliance with all applicable cGMP regulations, processes, systems and provisions of the Quality System. They host and manage regulatory authority and client inspections. They serve as a technical expert within the Quality Auditing department. They are responsible for results in terms of quality system conformance to regulations and Simtra quality policies.

The responsibilities:

• Perform internal audits by collecting and analyzing objective evidence regarding issues and risks. Report findings to management team.
• Host and manage regulatory inspections and corporate audits, including the response process and corrective action tracking.
• Host and manage audits conducted by the company's contract manufacturing clients.
• Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Communicate issues to management team.
• Manage the tracking, reporting, positioning, adequacy of actions, verification, closeout, and trending of audit-related corrective and preventive actions.
• Manage the assessment file through the process to closure.
• Perform follow-up audits to confirm corrective and preventive action is effective.
• Remain current in regulatory knowledge through attendance at related conferences, seminars, meetings, and other training methods such as independent study of periodicals, industry sources, Internet or other literature.
• Prepare management reports depicting trends for management review purposes.
• Manage and maintain the risk-based internal audit schedule. Act as a leader for the internal audit program.
• Lead continuous improvement initiatives for the Quality department.
• Act as а mentor/coach to other auditors, subject matter experts, and new hires.
• Serve as designee for Sr Manager, Quality Auditing.
• Conduct and report on gap assessments against regulations, guidances, regulatory findings, and Corporate procedures.
• Perform Compliance/Standards Impact Analyses for Change Control
• Perform Quality approval and Periodic Review for Standard Operating Procedure revisions that impact Quality Compliance.

Qualifications:

• Bachelor’s degree required (Science or Engineering preferred)
• Minimum 5-8 years of Quality, Compliance, Manufacturing, Engineering or Technical Services experience.
• Quality auditing experience in cGMP environments with experience in aseptic manufacturing environments.
• Independent auditor certification required (e.g., ASQ CQA, RAPS RAC, or ISO lead auditor).
• Extensive working knowledge of applicable quality and regulatory standards and regulations. Expertise in global GMP regulations.
• Excellent communication skills – both written and oral.
• Work effectively independently and in team environment.
• Must demonstrate sound judgment, problem-solving, and analytical skills to enable assessment of risk. Experience with risk management and root cause analysis preferred.
• Strong courage of conviction, conflict resolution, interpersonal and influencing skills.
• Ability to build relationships across functional boundaries at multiple levels internally/externally.
• Ability to demonstrate strong organizational and project management skills.
• Good working knowledge of Windows based applications.
• Resourceful, self-reliant, self-motivated and confident.
• Working knowledge of quality software systems (e.g. Veeva Vault).
• General knowledge of Lean Six Sigma and other continuous improvement tools.

Physical / Safety Requirements

• Must be able to gown qualify and don gowning materials for Grade B/A and Grade C areas on a routine basis.
• Duties will require overtime work as needed.
• Position requires sitting, standing, and walking for long periods of time, and navigating mechanical spaces within the facility.

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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