Training Specialist

GxP Training Specialist and Quality Systems

The Training Specialist supports Product Development and Manufacturing (PDM) and Quality organizations by assessing training impact, designing risk-based and compliant training solutions, and optimizing training curricula aligned to job roles and Quality System expectations. This role partners cross-functionally to translate learning strategy into effective, inspection-ready training deliverables that balance regulatory compliance with operational efficiency.

Responsibilities

* Partner with Subject Matter Experts, Business Process Owners, and functional leaders to assess training impact for new or revised governance procedures.

* Apply a risk-based approach to determine training requirements, target audiences, and appropriate delivery methods for diverse learner groups.

* Assess and optimize training curricula and role-based assignments to ensure alignment with functional responsibilities and Quality System expectations.

* Translate learning strategy into compliant, inspection-ready training deliverables in collaboration with project managers and key stakeholders.

* Serve as a Training Subject Matter Expert and advise cross-functional partners on effective, compliant, and modern training approaches.

* Independently analyze complex, cross-functional training impacts and propose practical, defensible training solutions that support compliance and efficiency.

* Support the design and execution of site or functional training programs that meet compliance goals and promote operational excellence.

* Assist in the development, maintenance, and governance of training content, training records, and training metrics in accordance with internal policies, procedures, and applicable regulations.

* Support administration and ongoing maintenance of the Learning Management System, including using training data and metrics to inform decisions and drive continuous improvement.

* Coordinate training-related activities and projects within defined objectives, timelines, and quality expectations.

* Proactively identify opportunities to improve training efficiency, enhance learner experience, and increase overall training effectiveness.

* Partner with department heads and stakeholders to evaluate and refine training plans based on business needs and quality requirements.

* Provide additional training and quality support as directed by leadership.

Essential Skills

* 6-8+ years of experience in a regulated pharmaceutical, biotechnology, or medical device environment.

* Direct experience in GxP training, Quality Systems, or compliance-driven training activities.

* Strong working knowledge of pharmaceutical Quality Systems and GxP training requirements.

* Demonstrated ability to exercise independent judgment on training impact and compliance-driven learning decisions.

* Proven experience applying risk-based thinking to training requirements while balancing regulatory expectations and operational needs.

* High attention to detail with the ability to anticipate downstream impacts to curricula, learners, and compliance.

* Effective communication skills with the ability to influence and constructively challenge stakeholders using data-driven rationale.

* Working knowledge of Learning Management System functionality, training data, and metrics.

* Experience in training development and training delivery or instruction.

* Quality-minded approach with strong risk-based decision-making skills.

* Ability to multitask and manage multiple training projects or initiatives simultaneously.

* Customer-service focus with the ability to build strong relationships and demonstrate genuine support for learners and stakeholders.

* Openness to innovative training methods beyond traditional read-and-understand approaches.

Additional

Skills & Qualifications

* Experience partnering with department heads and functional stakeholders to evaluate and optimize training plans.

* Ability to collaborate effectively in cross-functional teams within PDM and Quality organizations.

* Strong analytical skills to interpret training data and metrics and translate them into actionable improvements.

* Eagerness to learn and adapt to evolving training strategies, technologies, and regulatory expectations.

* Ability to serve as a trusted advisor on training and quality topics across different functions.

* Long-term commitment to a multi-year assignment, with the opportunity to contribute to sustained training excellence through April 1, 2028.

Work Environment

This role operates in a hybrid work environment, with on-site presence expected on Tuesday, Wednesday, and Thursday and remote work flexibility on other days as business needs allow. The position supports PDM and Quality functions in a regulated life sciences setting, working extensively with a Learning Management System and other digital tools to manage training content, records, and metrics. The environment emphasizes collaboration with cross-functional teams, data-driven decision making, and continuous…