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 Vice President of Quality will be responsible for the global quality operational management of the GMP facilities in Bloomington, IN & Halle, Germany. This individual will be responsible for managing quality strategy across two GMP facilities providing Quality oversight of clinical/commercial manufacturing operations. The VP of Quality will also be responsible for the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of operations to global GMP regulations. The VP of Quality is also responsible for assisting with the strategic alignment of sites, groups or team goals with projects and activities to global and corporate standards proactively. The primary objective is to ensure manufacturing processes are capable, compliant, in control, and continuously improved.

Key responsibilities:

  • Maintaining the company aware of all global regulations that may impact the Simtra BioPharma Solutions Operations Worldwide
  • Establishing a surveillance process for all deficiencies & observational themes surging in the global regulatory environment.
  • Managing the Regulatory Affairs teams in both Bloomington and Halle.
  • Maintaining up to date all Drug Master Files of the company and collaborating with clients to keep their submissions up to date.
  • Establish & Manage all communications with regulatory agencies like FDA (ESG & CDER Direct), EMA, Japan, Korea, Australia and others.
  • Perform Quality & Compliance Internal corporate Audits.
  • Interact with the Product Development groups to manage and submit all regulatory filings for customer as well as internal needs.
  • Help redact and review responses to Regulatory bodies that had conducted audits at our sites.

Key requirements:

  • Minimum of 12+ years pharmaceutical manufacturing, packaging, or laboratory experience including at least 10 years in clinical and or commercial quality operations.
  • Expert knowledge of GMP, FDA and EMA regulatory requirements applicable to parenteral drug products.
  • Strong knowledge of current industry trends and ability to use the latest technologies.
  • Working knowledge of Aseptic practices and clean room design/operations, auditing techniques.
  • Strong leadership skills with the ability to thrive in a high throughput environment.
  • Ability to lead and manage projects/teams within corporate objectives and project timelines.
  • Appreciation and desire to operate within a completely digital GMP environment.
  • Geneal knowledge of Quality Systems and compliance
  • Greater than 10 years experience in the field

Education:

  • B.S. degree required in Science or Engineering with an advance degree preferred.

In return, you’ll be eligible for:

  • 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
  • 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

Current benefit offerings are in effect through 12/31/24


 

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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To learn more about Simtra's approach to data privacy, please review the Simtra Recruitment Platform Global Privacy Policy:

https://biopharmasolutions.baxter.com/simtra-recruitment-platform-privacy-policy

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