PDM Program Specialist

Johnson & Johnson

. Lead and contribute to ARR (Adopting Regulatory Requirements) and Quality Framework Integration initiatives .

Posted 9/24/2026full-timeUnited StatesJunior💰 $79,000 - $127,650 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management System processes, regulatory compliance, and process design within the life sciences industry. Proficient in developing training materials and managing change initiatives while effectively communicating with stakeholders.

Highest-signal resume keywords

Quality Management System ProcessesRegulatory ComplianceProcess DesignTraining DesignChange Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Process ImprovementQualification ManagementRegulatory RequirementsClinical Compliance RegulationsDigital TechnologiesData-Related CapabilitiesProject ManagementAI ConceptsFirst-Time-Right PrinciplesContent Management

Soft Skills

Strong Communication SkillsAbility to Influence StakeholdersBusiness AcumenAdaptability to Changing PrioritiesCollaboration in Matrix Environment

Tools & Technologies

Microsoft OfficeProject Management ToolsAris CCL

Industry Keywords

PharmaceuticalMedical DeviceHealthcareGxP Quality Management FrameworkComplianceR&D EnvironmentTherapeutic AreasClinical DevelopmentRegulatory AffairsCAPAs

About the role

Key responsibilities & impact

Lead and contribute to ARR (Adopting Regulatory Requirements) and Quality Framework Integration initiatives
Assess, analyze, develop, implement, and integrate compliant end-to-end processes
Develop and maintain training and qualification materials within the GxP Quality Management Framework
Perform requirement comparison, assessment, and integration activities across the Quality Management System
Participate in content management and qualification transformation initiatives, including Aris CCL
Align business requirements, regulatory expectations, and Quality Management System processes
Contribute to activities associated with changes, CAPAs, inspections, investigations, and regulatory requests
Drive project activities related to timelines, deliverables, process design, training strategies, implementation, and maintenance
Manage assigned change management, risk management, issue resolution, and process analysis activities
Apply First-Time-Right principles to deliverables and program outputs
Provide project updates and communicate progress, risks, and resolutions to business owners and management
Advance data-centric content and qualification management initiatives
Work closely with Therapeutic Areas, Clinical Development, Medical Safety, Regulatory Affairs, and R&D Quality functions

Requirements

What you’ll need

Bachelor’s degree in Science, Business, or a related field
Minimum 1–3 years of experience in a medium-to-large matrix organization
Minimum 1 year of experience in a pharmaceutical, medical device, healthcare, compliance, or related R&D environment
Minimum 1 year of experience in process design, training design, qualification management, or a related field
Knowledge of global pre-clinical and clinical compliance regulations and guidelines
Awareness of regulatory and legal requirements within the life sciences industry
Experience contributing to process improvement, procedural integration, and qualification activities
Ability to work effectively within tight timelines and changing priorities
Ability to operate effectively in a matrix and virtual environment
Business acumen and understanding of organizational priorities
Basic understanding of digital technologies and data-related capabilities
Strong written and verbal communication skills
Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
Experience using project management tools
Understanding of AI concepts and frameworks, including responsible and ethical AI practices and effective prompting techniques
Ability to influence and align stakeholders within a matrix organization

Benefits

Comp & perks

Pension plan
401(k) savings plan
Long-term incentive program
Vacation – 120 hours per calendar year
Sick time – 40 hours per calendar year (with specified higher allowances for Colorado and Washington employees)
Holiday pay, including Floating Holidays – 13 days per calendar year
Work, Personal and Family Time – up to 40 hours per calendar year
Parental Leave – 480 hours within one year of birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Professional development opportunities
Hybrid work arrangement