Senior Manager, GxP Compliance Training

Simtra BioPharma Solutions•Bloomington, IN

About The Position

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. The role: The Sr. Manager, Global GxP Training Compliance is responsible for the GxP training compliance framework globally. Sitting with HR’s 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.

Requirements

Bachelor’s degree in Life Sciences, Education, Human Resources, Quality, or a related discipline.
8–10+ 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.

Responsibilities

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
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).
Identify and analyze systemic training compliance risks and trends.
Align systemic risk assessments with Quality’s risk management processes.
Recommend mitigation strategies consistent with Quality frameworks.
Escalate risks that may have regulatory impact to senior Quality and HR stakeholders.
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.
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.
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.