Manager, Combination Productions

002 ST Shared Services LLC; Dublin; Hybrid; EUR 56,000 - 94,000; Full time

Job summary

Keenova Therapeutics plc is seeking a Manager, Combination Products to oversee technical stewardship, lifecycle management, supplier oversight and long-term support of combination-product assets. The role requires coordination across Quality, Regulatory Affairs, Supply Chain, Manufacturing and external partners to ensure product continuity and regulatory compliance.

The position emphasizes lifecycle execution, product continuity planning and risk assessment, with a hybrid Dublin-based work

Qualifications

• Bachelor-level degree required in a technical field.
• Minimum 5 years of experience with medical devices or combination products.
• Knowledge of design controls, risk management, supplier controls, CAPA, change management, and relevant regulatory requirements.
• Experience working in cross-functional teams and strong communication skills.

Responsibilities

• Provide technical stewardship and lifecycle management for combination-product assets.
• Lead changes to product, component, supplier, manufacturing, and lifecycle processes.
• Maintain technical strategies, risk assessments, and continuity plans for products.
• Collaborate with Quality, Regulatory Affairs, Supply Chain, Manufacturing and Technical Operations to ensure compliance and continuity.

Skills

Strong written and verbal comms

Cross-functional collaboration

Independent technical issue evaluation

Lifecycle management experience

Regulatory knowledge awareness

Education

Bachelor's degree in engineering, pharmaceutical sciences, life sciences, or related technical discipline

Job description

Job Title

Manager, Combination Productions Requisition JR000016091 Manager, Combination Products (Open) Location College Park, Dublin Additional Locations

Summary

Summary Summary The Manager, Combination Products, is responsible for technical stewardship, lifecycle management, supplier oversight, and long-term support of combination-product assets. The role provides technical support for product continuity, lifecycle planning, change management, and supplier performance, ensuring that products remain compliant, reliable, and effectively supported throughout the commercial lifecycle. Working across Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external partners, the Manager integrates technical, quality, and business requirements to support product performance, continuity of supply, and lifecycle execution. The position serves as a key technical resource for combination-product assets and contributes to the ongoing development of the Combination Products capability

Essential Functions

• Provide technical support for stewardship, lifecycle management, and long-term support of combination-product assets.
• Maintain product technical strategies, lifecycle roadmaps, technical risk assessments, and product continuity plans supporting commercial combination-product assets.
• Lead technical assessment and implementation of product, component, supplier, manufacturing, packaging, and lifecycle changes.
• Establish and maintain effective technical relationships with external manufacturers, component suppliers, and development partners, supporting supplier governance and product performance.
• Support supplier qualification, technical due diligence, performance reviews, technical agreements, and ongoing oversight of critical suppliers and manufacturing partners.
• Assess and mitigate product, supplier, manufacturing, continuity-of-supply, and obsolescence risks, escalating significant issues as appropriate.
• Support technical investigations, product impact assessments, quality events, corrective actions, manufacturing transfers, alternate sourcing initiatives, and supplier-related changes affecting combination-product assets.
• Partner with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and Technical Operations to ensure successful lifecycle execution, product continuity, regulatory compliance, and maintenance of critical product knowledge.

Minimum Requirements Education / Experience / Skills:

• Bachelor's degree in engineering, pharmaceutical sciences, life sciences, or a related technical discipline required.
• Minimum 5 years of experience supporting medical devices, combination products, pharmaceutical products, or other regulated healthcare products.
• Working knowledge of combination-product regulatory requirements, including design controls, risk management, supplier controls, complaint handling, CAPA, change management, and applicable FDA, EU, Part 4, and ISO 13485 requirements.
• Understanding of product lifecycle management, manufacturing change assessment, supplier governance, technical risk assessment, and continuity-of-supply principles.
• Experience working effectively in cross functional teams.
• Strong written and verbal communication skills.
• Demonstrated ability to independently evaluate technical issues, assess risks, prioritize activities, and support compliant product and lifecycle decisions.

Organizational Relationship/Scope

The Manager, Combination Products reports to the Associate Director, Combination Products and operates as an individual contributor within the Combination Products team, which forms part of the broader Technical Operations organization. The position has no direct reports. The role works closely with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and other Technical Operations functions to support the stewardship and lifecycle management of combination-product assets. The position also interfaces with external manufacturers, suppliers, and development partners to support product continuity, lifecycle execution, and supplier oversight activities.

Working Conditions

This position is a hybrid role based in Dublin, Ireland and requires a minimum on-site presence of three (3) days per week. Work is performed in both office and pharmaceutical manufacturing environments, including cleanrooms, laboratories, packaging, warehousing, and other GMP-regulated areas. Travel is required to Internal and External manufacturing organizations (CMOs) and partner sites, and other domestic or international locations as business needs dictate

Disclaimer

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Salary Range €56,400 - €94,000

At Keenova, we believe that no one should be alone in their pursuit of better health. This purpose drives us as we pair quality therapeutics with human support—showing up in big moments and small to help patients find comfort and confidence. We bring deep expertise and resolve to every therapeutic area we serve, including immunology, urology, men’s health, orthopedics, critical care, and pediatric endocrinology. We work with patients, care partners, and physicians to help them navigate healthcare system complexity and access therapies that make a meaningful difference. We are Keenova—keen to solve, keen to serve. At Keenova, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Keenova and let’s do something dynamic together.

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.