Senior Specialist, Training Coordination & Compliance Operations

Job Description

The Biologics Process Research & Development organization within our Company Research Labs is responsible for developing the drug substance manufacturing processes for our Companys biologics pipeline. We work closely with colleagues in Discovery Pre-clinical and Early Development to rapidly develop processes for diverse biotherapeutics and efficiently produce material to supply clinical trials. We are also responsible for commercial process development and development and implementation of new technologies. We work with our partners in our Company Manufacturing Division to commercialize and launch new products.

This role will support the Next Generation Biologics (NGB) facility which will be a premier state-of-the-art facility that is a key part of our Chemistry Manufacturing and Controls (CMC) hub at our site headquarters in Rahway NJ. This facility will be fully online in the next few years both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites which can adjust as the clinical pipeline demands change. It can meet all historic currently existing and cutting-edge biologics program demands from supporting development to pilot scale small and large scale potent material handling and the ability to integrate new technologies and cell-line platforms.

The Sr. Specialist Training Coordination Compliance Operations is responsible for coordinating GMP training and qualification programs that support personnel qualification and compliance within the NGB facility. The role manages qualification programs training curricula; administers Learning Management System (LMS) activities training records and qualification documentation; coordinates SOP training requirements; and monitors training compliance partnership with Operations Quality and Subject Matter Experts (SMEs) this position maintains GMP training documentation and ensures personnel are appropriately trained and qualified to perform GMP activities.

Job Responsibilities:

• Coordinate GMP training and qualification programs supporting NGB Operations

• Partner with Operations leadership SMEs and process owners to establish role-based training and qualification requirements

• Monitor training compliance and qualification status identify gaps and drive remediation activities

• Manage training records and controlled documents in compliance with cGMP Data Integrity and Records Management requirements

• Administer and maintain LMS activities including curriculum management training assignments qualification tracking compliance monitoring and reporting

• Lead instructor-led training sessions and coordinate onboarding qualification and cross-training programs

• Coordinate and deliver training on GMP and process-related procedures as applicable

• Prepare and communicate qualification status reports compliance metrics dashboards and training documentation

• Evaluate training effectiveness and drive continuous improvement through metrics performance indicators and employee feedback

• Support implementation of digital learning technologies and tools that enhance manufacturing operations

• Serve as a resource for GMP training compliance qualification programs documentation practices and learning systems

Required Education Experience and Skills:

Education:

• Bachelors degree in Biological Sciences Engineering or a related discipline with a minimum of 5 years of relevant experience;

• Masters degree with a minimum of 3 years of relevant experience

Experience & Skills:

• Supporting GMP training and qualification programs within pharmaceutical biotechnology biologics or other regulated environments

• Developing training curricula qualification programs and role-based training requirements

• Coordinating GMP training programs qualification management and curriculum administration

• Managing training records qualification tracking and compliance reporting within an LMS

• Coordinating and leading instructor-led virtual self-paced and on-the-job training programs

• Monitoring training compliance and qualification status and implementing remediation actions

• Utilizing training metrics and analytics to monitor compliance and drive continuous improvement

• Managing controlled training documentation and supporting SOP implementation within GMP quality systems

• Leading training-related projects and initiatives from planning through execution

• Supporting digital learning technologies electronic work instructions and training management systems

• Strong written verbal facilitation and presentation skills

• Strong organizational planning and problem-solving skills

• Ability to manage multiple projects priorities and deadlines in a fast-paced GMP environment

• Ability to collaborate across functions and influence stakeholders to achieve business objectives

• Proficiency in LMS administration reporting and compliance tracking

• Knowledge of cGMP regulations training compliance requirements and documentation practices

Preferred Experience and Skills:

• Developing dashboards and training metrics to monitor compliance qualification status and training effectiveness

• Implementing or supporting digital learning technologies electronic work instructions and training management systems

• Supporting start-up commissioning qualification technology transfer or facility expansion activities in a GMP environment

• Supporting regulatory inspections and internal audits through training documentation compliance tracking and qualification record management

• Advanced data analytics and reporting capabilities

• Learning design and curriculum development capabilities

• Change management and organizational effectiveness skills

• Continuous improvement and process optimization methodologies

• Ability to leverage digital learning technologies to improve training effectiveness

#PRD

Required Skills:

Analytical Testing Analytical Testing Competency Management Dashboard Reporting Data Analysis Data Reporting Deviation Management Document Management Enterprise Leadership Equipment Qualification Good Manufacturing Practices (GMP) Implement Training Programs Management Development Metrics Development Organizational Change Management Process Design Process Hazard Analysis (PHA) Process Improvements Process Optimization Process Training Program Administration Progress Monitoring Root Cause Analysis (RCA) Technical Writing Training Coordination 1 more

Preferred Skills:

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The salary range for this role is

$117000.00 - $184200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

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Job Posting End Date:

10/3/2026

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