Manager - Quality Management

PwC; Bern; Vor Ort; CHF 220.000 - 320.000; Vollzeit

Zusammenfassung

CSL is seeking an Associate Director of Device Engineering in Bern, Switzerland, to lead the Device Engineering team for drug–device combination product development from concept through commercialization and sustaining. The role requires strong cross-functional leadership, external partner collaboration, and strategic oversight across CMC and product strategy.

You will own the Design History File, translate user needs into requirements, drive risk management and development plans, and coordinate

Qualifikationen

• 10+ years in pharma/medical device industry.
• Subject matter expert in medical device development, drug-device combination products.
• Excellent communication in a matrix environment.

Aufgaben

• Lead the Device Engineering team across assets with cross-functional inputs.
• Mentor Device Engineering team members and develop leadership skills.
• Own and coordinate device development activities, DHF maintenance, and regulatory submission support.
• Translate user needs and strategy into product requirements and aligned CMC plans.
• Lead risk management activities, hazard analyses, and mitigation planning.
• Represent device engineering on cross-functional program teams and manage integrated workplans.
• Establish relationships with suppliers and external partners to enable development and submissions.
• Drive end-to-end capabilities for drug–device development and foster innovation.
• Travel internationally up to 20%.

Jobbeschreibung

The Associate Director of Device Engineering is a leadership position in the Drug Delivery Systems & Packaging (DDSP) department within CSL’s Technical Operations. This role will report to the Director of Design Assurance.

The ideal candidate has a solid track record in the development of drug delivery devices, from concept development through commercialization and product maintenance, i.e., sustaining. The Associate Director of Device Engineering provides combination-product leadership and ensures that device-related development plans and evidence packages are integrated into the overall CMC and product strategy. The role requires strong cross-functional and external partner leadership, engineering team management, and stakeholder management.

Responsibilities

• Lead the Device Engineering team for drug–device combination product development across assigned assets, coordinating cross-functional inputs from Device Engineering, Human Factors, Quality, Regulatory, Clinical/Medical, Procurement, Manufacturing/Technical Operations, Supply Chain, Commercial, and external partners.
• Support and mentor Device Engineering team members, developing technical and leadership skills.
• Lead and coordinate device selection and development activities appropriate to the development stage, including inputs, outputs, verification and validation planning, supplier qualification, test strategy, documentation readiness, and regulatory submission support. Own and maintain the Design History File (DHF), ensuring documentation is complete, accurate, inspection-ready, and compliant with the CSL quality system and applicable regulatory frameworks for combination products.
• Translate user needs and program strategy into product requirements, development plans, milestones, risks, and deliverables. Ensure alignment between device design, Primary Packaging, Secondary Packaging, Human Factors, and overall CMC/product strategy.
• Lead risk management activities, including hazard analysis, risk assessments, and mitigation planning. Plan and implement combination product control strategy across supply in alignment with CMC. Support human factors and usability activities to ensure the user interface, instructional materials, and intended-use considerations align with patient needs and regulatory expectations. Set and drive best practices within DDSP for Device Engineering, including standardized approaches for design risk assessment, biological evaluation, and other key deliverables.
• Represent the device engineering team on cross-functional program teams and ensure combination product deliverables are aligned with program needs. Create, manage, and execute integrated workplans, timelines, decision logs, meeting cadences, risk registers, and escalation pathways. Partner with project leads and development teams to ensure clear priorities, timely execution, and effective resolution of risks and dependencies.
• Establish and maintain strong working relationships with suppliers, vendors, OEMs, testing labs, CMOs, and other external partners to enable development, qualification, and submission-supporting activities. Support sourcing strategy, due diligence, and business development assessments related to combination products within the scope of technical expertise.
• Implement and approve end-to-end capabilities for drug–device combination development within Drug Product Development, including playbooks, templates, best practices, and knowledge-sharing approaches. Drive innovation through technology scouting and evaluation, identifying opportunities to improve patient experience, manufacturability, robustness, and lifecycle flexibility. Represent CSL interests in industry forums such as ISO TCs and BioPhorum as well as sharing information from industry forums back to CSL colleagues.
• Own program-level tracking of timelines, risks, decisions, and deliverables to communicate progress clearly. Mentor Device Engineers, promote consistency across programs, monitor industry trends, standards, and regulatory guidance.

Education Requirements

Relevant academic qualification in an appropriate field, e.g., a suitable Science or Engineering degree.

Experience Requirements

• At least 10 years of related experience in the pharmaceutical or medical device industry.
• Subject Matter Expertise on medical device development with a preference for drug-device combination product development and sustaining.
• Excellent communication skills and a track record working in a matrix environment.
• Ability to influence and promote a culture of continuous improvement.

The role requires an ability to travel internationally up to 20%.