Sr. Manager, Quality Operations

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 Sr. Manager, Quality Assurance Line Operation (QALO) is a member of the Quality Assurance Leadership Team reporting directly to the Associate Director of Quality Assurance. He or she is a member of the Cell Leadership Team for one of the operations cells at the Bloomington site, providing leadership and direction for Aseptic Filling Quality Line Operations and indirect responsibility for all Quality functions interacting with the operations cell. The Sr. Manager, QALO, provides decision making and oversight to ensure compliance to all standard operating procedures for areas of responsibility. He or she must fully support and drive quality operations, communicate effectively with production team members, multiple levels of management, and other customer support departments. The Sr. Manager, QALO creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

* Plan, organize, direct, and evaluate applicable activities to ensure the safety and quality of manufactured products
* Demonstrates outstanding customer service to both internal and external clients.
* Develops and delivers solutions on time that meet customer expectations
* Demonstrates excellent leadership skills thru guidance, support, direction and through interactions with all personnel during daily operations. Must be a regular presence on the manufacturing floor.
* Interviews, hires, coaches, and develops staff. Conducts annual performance reviews for all direct reports. Assist in setting performance objectives and development plans.
* Creates/Develops a strong team by setting clear direction and empowering members to obtain results that support strategic objectives.
* Facilitate an environment of teamwork and communication between Quality Assurance, Production and other support functions as necessary to meet plant and department goals/objectives.
* Develops department annual budget and ensures spending within expected quarterly forecasts.
* Ensure Quality review of batch records in order to achieve internal targets and contractual commitments for batch release.
* Responsible for ensuring compliance to plant procedures, corporate quality policies, Federal and European regulations and guidance.
* Ensures training compliance for QA Line Operations.
* Responsible for establishing & trending quality metrics, taking action as required to meet regulatory requirements and customer expectations.
* Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
* Represent Quality Operations during client audits and regulatory inspections as needed. Provide information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs.
* Review and Approve Non-Conformance Reports for deviations and or non-compliance issues that occur during production activities and ensures thorough investigation, root cause analysis, and corrective and preventative action.

Required qualifications:

• Bachelor's degree required, preference in a Life Science field
• Minimum 7 years experience pharmaceutical industry experience.
• Minimum 3 years in a management role.
• Computer proficiency in Microsoft Office Suite and the ability to use ERP, E Quality & enterprise software

Physical / safety requirements:

• Must be able to qualify for entry into Class A/B aseptic facilities.
• Must wear appropriate personal protective equipment as applicable.
• 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 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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