For over 65 years, pharmaceutical and biotech companies have partnered with Simtra BioPharma Solutions (Simtra) to bring their sterile injectable products to market.
Simtra is a world-class Contract Development Manufacturing Organization with facilities in Indiana, US and Halle/Westfalen, Germany. We offer a wide-range of delivery systems including prefilled-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, at Simtra, there is a strong emphasis on quality and continuous improvement. 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.
In addition to unmatched expertise and experience, we offer a uniquely collaborative approach. Clients look to Simtra as an extension of their own companies.
It is very rewarding industry to work in. Our teams are driven to help clients scale, innovate, and bring-life changing medicines to patients worldwide.
Your Role At Simtra BioPharma Solutions
The Sr 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.
What You’ll Do
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.
What You’ll Bring
Bachelor's degree required; with preference for a Science or Engineering field.
Minimum five (5) 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 is desired.
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.
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