Senior Specialist, Operations (Project Management)

1000 Merck Sharp & Dohme LLC; North Carolina; Sur place; USD 96 000 - 151 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision health plans

401(k) retirement plan

Paid holidays & vacation

Sick days

Résumé du poste

MSD is seeking a Senior Specialist, Operations (Project Management) to lead complex projects at the Durham site. You will partner across Operations, Quality, Engineering, and Regulatory to advance filing readiness, change control, and incident investigations, while driving schedule performance and governance excellence.

The role emphasizes independent leadership, risk anticipation, and the ability to deliver high-visibility initiatives in a regulated manufacturing environment.

Qualifications

• Bachelor’s degree in Engineering, Science, Business, Project Management or related field.
• Minimum five years of relevant experience in manufacturing, operations, quality, engineering or project management (three years with a master’s).
• Experience coordinating cross-functional projects, workstreams or governance processes.

Responsabilités

• Coordinate cross-functional PAI and filing-readiness plans with owners, due dates, evidence and escalation paths.
• Maintain readiness trackers and dashboards providing visibility to milestones, risks and decisions.
• Lead portfolio intake, prioritization, sequencing, and governance aligned with site strategy.
• Lead Change Review Board activities and document decisions, actions, and owners.
• Author incident records and support problem solving with clear narratives and CAPAs.
• Develop integrated project schedules and report progress to governance forums.

Connaissances

Project leadership

Cross-functional coordination

GxP/regulatory awareness

Technical writing

Formation

Bachelor’s degree in Engineering, Science, Business, Project Management

Five years manufacturing or regulatory experience

Outils

MS Project

Description du poste

Job Description

Our Manufacturing Operations teams make and supply products with a “Safety First, Quality Always, Inclusion for All” mindset and a focus on continuous improvement. Team members work within the local plant and across the global manufacturing network to support reliable, compliant delivery of high-quality materials and finished products. The Senior Specialist, Operations (Project Management) supports the Durham manufacturing site as a project leader and governance partner. The role independently leads complex, high-visibility initiatives; advises functional leaders; anticipates execution risks; and establishes the governance, reporting, and decision‑making practices needed to achieve site and business objectives. This position works across Operations, Quality, Engineering, Technical Operations, Automation, Regulatory, and other functional areas to advance inspection readiness, filing deliverables, portfolio priorities, change control, incident writing, and schedule performance.

Key Responsibilities

PAI and Filing Readiness

Coordinate cross‑functional Pre‑Approval Inspection (PAI) and filing‑readiness plans, including deliverables, owners, dependencies, due dates, evidence, and escalation paths. Maintain integrated readiness trackers and dashboards that provide accurate visibility to critical milestones, risks, gaps, decisions, and recovery actions. Facilitate readiness reviews, working sessions, and governance updates; document decisions and drive action closure with accountable owners. Partner with subject matter experts to support preparation and quality review of filing‑related documents, inspection evidence, procedures, training records, and supporting materials. Identify schedule or compliance risks early and coordinate mitigation plans that protect filing and inspection‑readiness objectives.

Project Portfolio Management

Manage the functional project portfolio by maintaining a current inventory of projects, priorities, resource needs, interdependencies, benefits, risks, and status. Lead portfolio intake, prioritization, sequencing, and review processes using consistent criteria aligned with site strategy, capacity, compliance, and business value. Develop portfolio summaries and dashboards that enable timely decisions, resource alignment, and escalation of constraints. Coach project leads on project charters, scope, milestones, governance, risk management, action tracking, and closeout expectations. Promote disciplined project controls, data accuracy, and a single source of truth across portfolio tools and reporting routines.

Change Review Board Leadership

Lead the Change Review Board (CRB) operating rhythm, including agenda development, intake review, meeting facilitation, decision documentation, and follow‑up. Coordinate cross‑functional assessment of proposed changes for scope, quality, regulatory, technical, operational, validation, supply, schedule, and resource impacts. Ensure change proposals are sufficiently defined for review and that decisions, conditions, owners, and required actions are clearly captured and communicated. Monitor the change portfolio through implementation and closure, escalating aging actions, unresolved dependencies, and risks to the appropriate governance forum. Continuously improve CRB standards, templates, metrics, and workflows to strengthen decision quality, speed, and accountability.

Incident Writing and Investigation Support

Author and coordinate incident and deviation records in partnership with Operations, Quality, Engineering, Technical Operations, and other subject matter experts. Build clear, fact‑based event narratives and support problem definition, impact assessment, root‑cause analysis, corrective and preventive actions, and on‑time record progression. Facilitate investigation working sessions, track information requests and approvals, and maintain visibility to investigation milestones and potential delays. Apply strong technical writing practices to ensure records are concise, accurate, traceable, and aligned with applicable procedures and cGMP expectations.

Project Scheduling and Operational Excellence

Develop and maintain integrated project schedules that include activities, logic, dependencies, milestones, critical paths, constraints, and resource assumptions. Partner with workstream leads to update progress, evaluate schedule impacts, identify recovery options, and communicate forecast changes. Produce routine schedule and milestone reporting for project teams and governance forums, with emphasis on exceptions and decisions required. Support continuous improvement initiatives that strengthen planning, governance, cycle time, right‑first‑time performance, and execution reliability. Participate in site tier processes, gemba walks, readiness reviews, and other operational routines as assigned.

Core Competencies

Project leadership and cross‑functional facilitation. Portfolio governance, prioritization, risk identification, and executive communication. Integrated scheduling, dependency management, and critical‑path thinking. Coaching and capability development. Technical writing, investigation support, and document quality. Ability to influence without direct authority and work effectively in a matrixed environment. High attention to detail, strategic thinking, adaptability, and commitment to data integrity.

Required Education, Experience, and Skills

Bachelor’s degree in Engineering, Science, Business, Project Management, or a related field. Minimum of five years of relevant experience in manufacturing, operations, quality, engineering, project management, or a related regulated environment (or three years with a master’s degree). Demonstrated experience coordinating cross‑functional projects, workstreams, or governance processes. Demonstrated written and verbal communication skills, including the ability to create clear technical or business documentation. Experience maintaining project plans, schedules, action logs, risk registers, dashboards, or portfolio reports. Ability to work independently, manage competing priorities, and escalates issues with clear recommendations.

Preferred Experience and Skills

Experience supporting PAI, general inspection readiness, regulatory filings, licensure, commercialization, or manufacturing start‑up activities. Experience leading or supporting a change control or Change Review Board process. Experience authoring or supporting deviations, incidents, investigations, root‑cause analyses, and CAPAs. Experience with scheduling and portfolio tools such as Microsoft Project or equivalent systems. Knowledge of cGMP requirements and experience working in vaccine, biologics, pharmaceutical, or other regulated manufacturing environments. Familiarity with formal problem‑solving and continuous‑improvement methodologies such as RCA, FMEA, Lean, or Six Sigma. Project Management Professional (PMP), Lean Six Sigma, or comparable training and certification.

Work Expectations

Periodic off‑shift or weekend support may be required based on business needs, inspection‑readiness activities, incident response, or project milestones. Travel: Up to 10% based on business needs.

Required Skills

Adaptability, Analytical Problem Solving, cGMP Compliance, Change Controls, Coaching, Communication Sciences, Data Analysis, Data Integrity, Decision Making, Good Manufacturing Practices (GMP), Inspection Readiness, Inventory Management, Lean Six Sigma Continuous Improvement, Manufacturing, Manufacturing Technologies, Meeting Facilitation, Microsoft Project, Personal Initiative, Pre Approvals, Process Improvements, Process Optimization, Production Planning, Production Scheduling, Project Charters.

Preferred Skills

Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts.

Primary Location

USA - North Carolina - Durham (Old Oxford)

Compensation

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $96,200.00 - $151,400.00. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s 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.

Benefits

• 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 https://jobs.merck.com/us/en/compensation-and-benefits. Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional Location(s) Compensation Information

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 Search Firm Representatives Please Read Carefully 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: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A

Job Posting End Date

11/18/2026

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.