Director, CSV - Quality & Compliance

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 Computer Systems Validation Director leads both the Corporate CSV Team and Contract Partners in the delivery of compliant GXP IT Solutions globally. The role leads the culture, technical competency and improvement initiatives and works in partnership with senior IT leaders for the implementation and maintenance of applications and infrastructure in all Simtra global workstreams. These include ERP, Lab, QMS, GXP Reporting, Validation and Qualification Policies, SOPs and tools. The outcome of the role is to ensure that both Simtra Corporate and Simtra sites are ready at the point of inspection and the compliance status of GXP Computer Systems is known at all times. The position is 100% remote.

The responsibilities:

• Lead and develop the existing global validation practices for applications
• Lead and develop the existing global qualification practices for infrastructure
• Lead and develop the CSV QMS policies, SOPs and tools assuring alignment with sites, global regulations and industry best practice
• Lead the global CSV Centre of Excellence and Community of Practice. (CSV Opinion and thought leader globally)
• Build the corporate CSV Team assuring SME skills, development and cover for both EU and US regions
• Assure compliance mechanisms are established to monitor computer systems compliance both at the corporate and site levels
• Assure that compliance dashboards are in place for both site and corporate computer systems compliance
• Drive both internal inspection program and external inspection responses for CSV compliance including infrastructure
• Provide senior SME technical CSV guidance for best practice regarding specific project approaches in partnership with CIO and IT Technology leaders

Required qualifications:

• BS degree in science or computer related field, preferred
• 10 years quality system validation experience required
• Experience with computer system databases (SQL or Oracle preferred)
• Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, Training and Documentation System, Maximo, Trackwise, etc.)
• Working experience with SAAS and infrastructure preferred
• Strong SME knowledge of SDLC, CSV, CSA, infrastructure technology both new and emerging
• Willing to travel to support both site and corporate functions
• Willing to work multiple time zones and flexible work hours to support both EU and US

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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

Data Privacy

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