Job Description:
We are seeking an experienced Organizational Change Management Lead to support a portfolio of Quality transformation initiatives in a regulated pharmaceutical / biotechnology environment.
The ideal candidate is not simply a communications or training resource. This person must be able to design and execute integrated OCM strategies that connect process changes, controlled document updates, role impacts, training needs, stakeholder readiness, sponsor engagement, go-live support, and sustainment.
The role requires a senior, hands-on change leader who can work directly with Quality leaders, process owners, SMEs, project teams, technical teams, and cross-functional business partners to ensure that changes are adopted, sustained, and inspection-ready across multiple initiatives.
This role is responsible for the people-side adoption strategy and execution support for Quality (supported) transformation initiatives. The OCM Lead will partner closely with project managers, process owners, Quality system owners, training owners, and technical teams, but does not replace those roles.
The OCM Lead is expected to:
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Own the OCM strategy, adoption plan, stakeholder engagement approach, readiness planning, and sustainment approach.
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Partner with process owners and SMEs to understand process impacts and future-state behaviors.
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Partner with Training to ensure learning activities are role-based and aligned to future-state execution.
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Partner with PMO/project leads to integrate OCM milestones into the overall project plan.
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Partner with Quality and system owners to ensure adoption planning supports GxP readiness and inspection confidence.
The OCM Lead is not expected to configure systems, own formal GMP change control, author all SOP content, or act as the primary project manager.
The organization is implementing multiple Quality transformation initiatives that affect how teams execute, review, approve, escalate, and sustain Quality processes. These initiatives may include changes to procedures, work instructions, systems, data flows, review models, roles, decision rights, training expectations, governance forums, and ways of working across Quality and cross-functional partner teams.
These programs require more than training and communication. They require clear adoption planning, stakeholder alignment, role-based impact assessment, readiness management, leadership reinforcement, and post-go-live sustainment to ensure that new ways of working are embedded into day-to-day execution.
The OCM Lead will support a portfolio of Quality transformation efforts by helping teams identify what is changing, who is impacted, what behaviors or capabilities need to shift, what readiness risks exist, and what actions are needed to ensure reliable, inspection-ready adoption.
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Develop and maintain an integrated OCM plan for Quality transformation programs.
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Develop and maintain a portfolio-level view of OCM demand, priorities, risks, and resource needs across multiple Quality transformation initiatives.
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Translate project scope, timeline, document changes, system releases, and process changes into a clear adoption roadmap.
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Define OCM activities by change impact level: low, medium, high, and transformational.
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Integrate OCM milestones into the broader project plan and phase gate process.
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Identify adoption risks early and recommend mitigation actions.
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Build stakeholder maps across Quality, Manufacturing, Labs, MSAT/ASAT, Regulatory, Technical Operations, Data, IT, Training, and external partner teams as applicable.
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Conduct role-based change impact assessments.
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Identify changes to responsibilities, decision rights, review behaviors, escalation paths, data usage, system interactions, and governance.
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Group impacted populations by level of change and required OCM support.
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Identify where new or updated SOPs/WIs require additional behavior change, training, communications, or manager reinforcement.
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Support sponsors and senior leaders in articulating the case for change.
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Develop sponsor talking points, leadership messages, and reinforcement actions.
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Help leaders understand where visible sponsorship is required to reduce resistance and drive adoption.
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Prepare leadership updates for program governance and Steering Committee forums.
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Develop targeted communication plans for impacted stakeholder groups.
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Create practical messaging that explains what is changing, why it matters, who is impacted, what actions are required, and when.
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Support SME briefings, roadshows, office hours, FAQ development, manager toolkits, and readiness sessions.
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Ensure communications are aligned with the project timeline, document effective dates, training deployment, and go-live waves.
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Partner with Training, Quality Systems, process owners, and SMEs to ensure training is role-based and tied to actual future-state execution.
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Identify where training alone is insufficient and where coaching, walkthroughs, job aids, or readiness checks are needed.
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Support go-live readiness assessments across people, process, technology, data, documents, and support model.
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Define readiness criteria for each go-live wave.
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Define 30/60/90-day sustainment plans after go-live.
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Establish adoption metrics, feedback loops, issue escalation paths, and business-as-usual ownership.
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Monitor adoption risks, behavior drift, workarounds, and inconsistent execution.
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Ensure lessons learned are captured and fed into future phases and programs.
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Ensure OCM deliverables support implementation in a regulated GxP environment.
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Understand the difference between Organizational Change Management and formal GMP change control.
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Ensure OCM activities align with controlled document updates, training requirements, inspection readiness, and quality risk management expectations.
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Support adoption evidence that demonstrates the organization is ready to execute the new process reliably.
The contractor should be able to create and maintain the following:
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OCM strategy and roadmap
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Portfolio OCM intake / prioritization view
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Change impact assessment
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Stakeholder map
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Sponsor and change champion plan
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Communication and engagement plan
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Training and readiness integration plan
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Go-live readiness checklist
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Adoption risk register
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30/60/90-day sustainment plan
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Leadership / Steering Committee updates
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SME workshop materials
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FAQs, manager talking points, and change story materials
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Adoption metrics and status dashboard
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Lessons learned and continuous improvement recommendations
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10+ years of experience in Organizational Change Management, business transformation, Quality transformation, or related discipline.
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Prior experience leading OCM for complex, cross-functional programs.
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Experience operating at Associate Director / Director level or equivalent.
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Demonstrated ability to work with senior leaders, sponsors, process owners, SMEs, and project teams.
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Strong experience with stakeholder analysis, change impact assessment, sponsor activation, communication planning, readiness planning, and sustainment.
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Experience supporting phased deployments with multiple go-live waves.
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Strong facilitation skills, including ability to lead workshops with SMEs and leaders.
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Ability to translate complex process and system changes into simple, actionable messages for impacted users.
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Strong PowerPoint and executive communication skills.
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Comfortable creating practical working materials using PowerPoint, Excel, SharePoint/Teams, project plans, trackers, dashboards, and workshop outputs without relying on a separate analyst or designer.
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Ability to operate independently with limited direction.
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Experience in pharmaceutical, biotech, medical device, or other regulated life sciences environment.
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Understanding of GxP / GMP expectations and how process, document, training, and system changes are implemented in a regulated environment.
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Familiarity with Quality Management System processes such as controlled documents, training, deviations, CAPA, change control, batch disposition, quality review, lab systems, manufacturing systems, or inspection readiness.
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Ability to work within a Quality organization where compliance, data integrity, training evidence, and inspection readiness matter.
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Experience supporting Quality transformation initiatives involving controlled documents, training, process redesign, digital systems, data flows, governance changes, or new operating models.
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Experience supporting Quality transformation initiatives involving enterprise Quality systems such as document management, LMS, QMS, LIMS, MES, data/reporting platforms, or similar systems. The candidate does not need to configure these systems, but must understand how system-enabled changes affect roles, procedures, training, data flows, readiness, and sustained adoption.
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Experience supporting phased deployments with multiple sites, functions, systems, or go-live waves.
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Experience supporting digital Quality transformation, automation, AI-enabled processes, risk-based review models, or data-driven oversight models.
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Experience with small molecule, biologics, cell and gene therapy, and/or device-related Quality processes.
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Experience creating OCM playbooks, toolkits, templates, or reusable change-management frameworks.
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Certification in Prosci, ACMP, Kotter, or equivalent change-management methodology preferred, but practical experience is more important than certification.
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Strategic enough to design the approach; hands-on enough to build the materials.
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Comfortable challenging program teams when training is being treated as the only adoption activity.
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Able to simplify complexity without losing Quality or compliance nuance.
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Strong executive presence with the ability to influence without formal authority.
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Able to connect people, process, technology, data, documents, and training into one adoption plan.
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Comfortable working in ambiguity and building structure where it does not yet exist.
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Pragmatic and risk-based; does not over-engineer low-impact changes but does not under-manage high-impact transformation.
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Strong written and verbal communication skills.
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High attention to detail and strong follow-through.
Pay Range:
$90-$100/hr
Requisition Disclaimer:
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements
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