GxP Training Specialist
Actalent, San Mateo, CA, United States
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 improvement in training effectiveness and learner experience.
Job Type & Location This is a Contract position based out of Foster City, CA.
Pay and Benefits The pay range for this position is $55.00 – $80.00/hr.
Benefits Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)
Application Deadline This position is anticipated to close on Apr 17, 2026.
Equal Opportunity Employer Actalent is an equal opportunity employer.
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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 improvement in training effectiveness and learner experience.
Job Type & Location This is a Contract position based out of Foster City, CA.
Pay and Benefits The pay range for this position is $55.00 – $80.00/hr.
Benefits Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long‑term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)
Application Deadline This position is anticipated to close on Apr 17, 2026.
Equal Opportunity Employer Actalent is an equal opportunity employer.
#J-18808-Ljbffr