Director PMO

Project Director — Operational Readiness, Biosurgery

Role Summary

The Project Director will lead in the establishment of new capabilities within Johnson & Johnson MedTech Surgery, Biosurgery and drive operational readiness for commercial operations of new products. This role is responsible for activities such as end-to-end planning and execution to bring the site(s)from construction completion through commissioning, validation, regulatory readiness, initial commercial production and subsequent successful ramp to full-scale high-volume manufacturing. The Project Director will shape and lead an operational readiness program for transitioning new products to large‑volume commercial supply and build the technical, operational, and organizational capabilities required for process development and commercialization of the product pipeline. The role aligns cross‑functional teams (R&D, Quality, Regulatory, Manufacturing, Facilities, Supply Chain, EHS) and external partners to deliver a compliant, safe, and efficient production capability on schedule and within budget.

Main Duties & Responsibilities

· Lead program governance and execution for commercial supply operational readiness across the supply chain.

· Project‑lead the creation and operationalization of capability within Biosurgery.

· Be accountable for site(s) startup, operational readiness, and new product launches.

· Develop and maintain the Master Project Plan with clear milestones for construction completion, equipment installation, commissioning, qualification (IQ/OQ/PQ), process validation, and transfer to production.

· Own project budget, reporting, risk register, change control, and contingency planning; drive timely decisions to meet schedule and financial targets.

· Define and implement the Validation Master Plan and oversee IQ/OQ/PQ execution across systems, equipment, utilities, and cleanrooms.

· Coordinate design transfer / technology transfer from R&D to manufacturing: develop transfer plans, define acceptance criteria, and lead pre‑production runs.

· Ensure compliance with medical device regulatory and quality requirements (e.g., 21 CFR 820 / FDA QSR, ISO 13485, ISO 14971) and support regulatory submission readiness as needed.

· Build and lead cross‑functional operational readiness teams including Manufacturing Engineering, Quality, Production, Supply Chain, Maintenance, Facilities, and EHS.

· Recruit, onboard, and train site leadership and core operations staff; develop competency matrices and launch staffing plans.

· Manage relationships with contractors, equipment vendors, CMOs, and consultants; negotiate contracts and ensure vendor deliverables meet specifications and timelines.

· Define KPIs for operational readiness and new product launch, report progress to executive leadership and stakeholders.

· Lead continuous improvement and lesson-learned activities to refine future site startups and product introductions.

Required Experiences, Competencies & Qualifications

· Bachelor’s degree in engineering, Life Sciences, or a related field; advanced degree preferred.

· Minimum 10 years of experience in medical device manufacturing with demonstrated leadership in site startup, technology transfer, capital projects, or operational readiness.

· Proven experience leading multidisciplinary teams and complex capital programs.

· Deep working knowledge of medical device quality and regulatory requirements (21 CFR 820 / FDA QSR, ISO 13485) and experience delivering compliant manufacturing facilities.

· Direct experience with commissioning, IQ/OQ/PQ, Validation Master Plans, and process validation for device manufacturing.

· Strong program and project management skills including risk management, schedule control, budgeting, and stakeholder reporting.

· Excellent communication and influencing skills, with experience working with senior leadership and external partners.

• Ability to travel >50% of your time as required between sites, vendors, and stakeholders.
• Experience launching multiple products into commercial production.

Preferred Qualifications

· PMP, PRINCE2, or equivalent project management certification.

· Lean / Six Sigma training or certification.

Competencies & Leadership Attributes

· Strategic thinker with strong operational execution focus.

· Decisive, pragmatic problem‑solver who escalates appropriately and remains calm under pressure.

· Strong collaborator who aligns cross‑functional priorities and creates accountability.

· Demonstrated ability to develop individuals and build high‑performing teams.

· Customer‑ and quality‑focused with a strong commitment to patient safety and compliance.

Additional Requirements

· This position is not eligible for remote work and may require 50%–75% international travel.

· Responsible for following all company Health, Safety and Environmental practices and ensuring subordinates do the same.

· Responsible for ensuring compliance with all applicable Federal, State, local and Company regulations, policies, and procedures.

Location: Nijmegen, onsi