Sr Manager, Quality DPCS

Baxter Pharmaceutical Solutions, LLC; Indiana, Bloomington (PA, IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Join a forward-thinking organization dedicated to excellence in quality assurance within the pharmaceutical sector. As a Sr Quality Manager, you will lead efforts to implement robust quality systems, ensuring compliance with industry standards while fostering a culture of teamwork and innovation. Your expertise will directly impact the development of life-changing medicines, providing quality oversight throughout the manufacturing process. This dynamic role offers the chance to collaborate with cross-functional teams, driving continuous improvement and ensuring the highest standards of safety and quality are met. If you are passionate about making a difference in patient health, this opportunity is for you.

Benefits

Medical & Dental Coverage

Flexible Spending Accounts

401(k) Retirement Savings Plan with Company Match

Paid Time Off

Education Assistance Program

Employee Assistance Program

Community and Volunteer Service Program

Onsite Workout Facility

Cafeteria

Credit Union

Qualifications

• 7+ years in pharmaceutical or biotech industry required.
• Expertise in quality assurance and compliance with FDA standards.

Responsibilities

• Design and implement quality systems for development and pre-commercial services.
• Ensure quality oversight of pre-commercial manufacturing.
• Develop data management strategies and ensure data integrity.

Skills

Quality Assurance

FDA CFR Guidelines

ICH Guidelines

Data Integrity

Risk Management

Team Collaboration

Education

Bachelor's Degree in Scientific Discipline

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

JDE

BPLM

Pilgrim

Trackwise

Job description

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 Quality Manager is a member of the Quality Assurance Team reporting directly to the Site Quality Director. The Sr Quality Manager of Development and Pre-Commercial Services (DPCS) is responsible for designing and implementing quality systems and resourcing required to support the DPCS program, ensuring quality oversight of development work and GMP products produced within the clinical suite. In addition, the Sr Quality Manager is expected to be able to partner with leadership and external customers within the DPCS program and provide quality guidance on project decisions. The Sr Quality Manager is expected to contribute to an environment where teamwork and productivity are encouraged, and safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

The responsibilities:

• Build a phase-based approach to adapt Simtra quality systems to DP clinical manufacturing through life cycle of a biological product or API


• Integrate FDA CFR and ICH guidelines at a minimum


• Accountable for integration of quality by Design approach to process development and process controls


• Adapt qualification and validation studies to pre-commercial phases requirements


• Develop a data management strategy adapted to development and pre-commercial services


• Ensure high level of data integrity and traceability


• Accountable to establish adequate risks management levels from pre-clinical to late clinical phase manufacturing


• Ensure good practices in the process and analytical development laboratories


• Represents point of contact between DPCS and QC for prioritization, risk management and escalation as needed


• Ensure quality oversight of pre-commercial manufacturing on the shop floor


• Responsible for the quality oversight of all GMP documentation & training for DPCS


• Develop strong partnership with the Head of Development & Pre-commercial Services on site


• Support customer's visits and meetings as appropriate

Desired qualifications:

• Bachelor's Degree in scientific or related discipline required


• Minimum 7 years of experience in a pharmaceutical or biotech industry required


• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

• Must be able to sit and stand for extended periods of time.


• Must wear appropriate personal protective equipment as applicable.


• Duties may require overtime work, including nights, holidays and weekends.


• Use of hands and fingers to manipulate office equipment is required.

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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