Senior Manager, GxP Compliance Training

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 teamsso we can solve problems in new ways.

Make it RIGHT We hold ourselves to a high standard of excellencefulfilling 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.

The role:

The Sr. Manager Global GxP Training Compliance is responsible for the GxP training compliance framework globally. Sitting with HRs Global Learning & Development organization this role ensures consistent standards governance and execution of training compliance across all GxP sites.

This role partners closely with Quality to ensure alignment with regulatory expectations and Quality governance. Quality retains final accountability and approval authority for all GxP compliance decisions regulatory interactions investigations deviations and CAPA outcomes.

Key Responsibilities

• Global Framework & Operating Model
  • Define maintain and evolve the global GxP training compliance framework including standards controls documentation expectations and training evidence requirements.
  • Establish a consistent operating model across all sites ensuring aligned interpretation and application of GxP training standards.
  • Provide clear guidance and tools to harmonize execution across the enterprise
• Inspection Readiness & Monitoring
  • Maintain an inspection-ready training compliance system through ongoing monitoring trend analysis and oversight.
  • Provide guidance to site GxP Training Administrators on documentation traceability and inspection preparedness.
  • Support regulatory inspections and internal audits as an SME while not acting as the primary regulatory contact or owner of site audit responses (Quality retains this role).
• Risk Identification & Escalation
  • Identify and analyze systemic training compliance risks and trends.
  • Align systemic risk assessments with Qualitys risk management processes.
  • Recommend mitigation strategies consistent with Quality frameworks.
  • Escalate risks that may have regulatory impact to senior Quality and HR stakeholders.
• Investigations Deviations & CAPAs (Oversight & Consistency)
  • Provide global oversight for training-related investigations to ensure consistent root cause approaches aligned with Quality expectations.
  • Define global expectations for training-related CAPAs and review for consistency and effectiveness.
  • Facilitate cross-site learning and harmonization.
  • Quality retains final ownership approval and closure authority for all investigations deviations and CAPAs.
• Governance & Quality Partnership
  • Act as the primary point of contact to Quality leadership for training compliance.
  • Ensure all GxP training standards and processes align with Quality governance and messaging.
  • Represent the GxP training function in Quality forums management reviews and CAPA/Deviation governance providing enterprise-level insights and systemic trends.
• People Leadership & Functional Management
  • Lead and develop the global network of site GxP training professionals.
  • Set clear priorities role expectations and performance standards aligned with the global framework.
  • Ensure appropriate capability coverage and succession planning.
  • Drive consistent ways of working decision-making and escalation practices across sites.

Required Qualifications

• Bachelors degree in Life Sciences Education Human Resources Quality or a related discipline.
• 810 years of experience in GxP-regulated environments (e.g. pharmaceutical biotech medical devices) with direct exposure to GxP training compliance.
• Demonstrated experience establishing and managing global GxP training compliance frameworks standards or operating models across multiple sites.
• Strong working knowledge of applicable regulations and guidance related to training compliance (e.g. FDA EMA ICH EU Annex 11 GDP/GMP training expectations).
• Proven experience preparing for and supporting regulatory inspections and audits related to training compliance including inspection readiness activities.
• Experience identifying and trending systemic training compliance risks and partnering with Quality to escalate and address regulatory risk.
• Demonstrated people leadership experience including leading site-based or geographically dispersed teams.
• Ability to provide clear authoritative guidance while operating effectively in a matrixed highly regulated environment.
• Strong written and verbal communication skills with the ability to engage effectively with Quality site leadership and senior stakeholders.

Leadership Competencies

• Attracts Top Talent: Attracts and selects the best talent to meet current and future business needs
• Builds Effective Teams: Builds strong teams that apply their diverse skills and perspectives to achieve common goals.
• Demonstrates Self Awareness: Uses a combination of feedback and reflection to gain productive insight into personal strengths and weaknesses.
• Drives Engagement: Creates a climate where people are motivated to do their best to help the organization achieve its objectives.
• Drives Vision and Purpose: Paints a compelling picture of the vision and strategy that motivates others to action.
• Financial Acumen: Interprets and applies understanding of key financial indicators to make better business decisions.
• Manages Ambiguity: Operates effectively even when things are not certain or the way forward is not clear.

Governance Clarification

This Role (HR Global Learning)

Owns:

• The global GxP training compliance framework standards and operating model
• Enterprise-level oversight monitoring and systemic risk visibility
• Consistency of execution and cross-site harmonization

Does Not Own:

• Regulatory authority
• Final compliance decisions
• Approval/closure of investigations deviations or CAPAs
• Primary regulatory inspection interactions Quality

Retains Ownership & Final Authority For:

• GxP compliance decisions and regulatory interpretations
• All regulatory interactions and inspection responses
• Approval and closure of investigations deviations and CAPAs
• Overall Quality oversight and governance of GxP activities

In return youll be eligible for1:

• Day One Benefits
  • Medical & Dental Coverage
  • Flexible Spending Accounts
  • Life and AD&D Insurance
  • Supplemental Life Insurance
    • Spouse Life Insurance
    • Child Life 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
  • Short and Long-Term Disability Insurance
  • 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 12/31/26

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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Senior Manager