Senior Manager, Combination Products

Hybrid Working

College Park, Dublin

Full time

JR000016092

Job Title

Senior Manager, Combination Products

Requisition

JR000016092 Senior Manager, Combination Products (Open)

Location

College Park, Dublin

Additional Locations

Job Description Summary

Summary

The Senior Manager, Combination Products serves as the principal technical expert for combination-product assets and provides technical leadership across design controls, product quality, engineering, risk management, and lifecycle support activities. The role applies deep combination-product expertise to complex technical, quality, regulatory, and manufacturing issues, ensuring that decisions remain compliant, scientifically sound, and aligned with business objectives.

Working in association with partner functions, the Senior Manager influences technical strategy and decision-making through expertise rather than direct authority. The position serves as a key knowledge resource for combination-product assets, supporting product stewardship, investigations, lifecycle changes, regulatory compliance, and the technical assessment of future combination-product opportunities

Job Description

Essential Functions

• Serve as the principal technical expert for combination-product assets and provide technical leadership for design controls, engineering, product quality, risk management, and lifecycle support activities.

• Maintain technical oversight of design history documentation, design control processes, risk management activities, and associated compliance requirements for combination-product assets.

• Lead technical evaluations supporting product, component, supplier, manufacturing, and lifecycle changes, providing guidance and recommendations on complex technical decisions.

• Provide technical leadership for verification and validation activities, design-risk assessments, engineering evaluations, and product performance assessments supporting product quality and regulatory compliance.

• Lead and support investigations related to product complaints, quality events, manufacturing deviations, supplier issues, and CAPAs, including assessment of technical and product impact.

• Support regulatory submissions, inspections, audits, and agency interactions through the preparation and review of technical assessments, justification documents, and regulatory responses.

• Provide technical due diligence and assessment support for future combination-product opportunities, including evaluation of product design, manufacturability, technical risks, and lifecycle requirements.

• Act as a key knowledge resource within the Combination Products function, influencing technical strategy and decision-making through expertise, mentoring, and cross-functional collaboration.

• Support development of resource plans, project cost estimates, business cases, and investment proposals for combination-product programs by providing technical assessments, execution assumptions, risk evaluations, and subject matter expertise.

• • Minimum Requirements Education / Experience / Skills:

• Bachelor's degree in engineering, pharmaceutical sciences, life sciences, quality, or a related technical discipline required; advanced degree preferred.Minimum 8 years of experience supporting medical devices, combination products, pharmaceutical products, or other regulated healthcare products.Demonstrated experience in design controls, risk management, product quality, engineering, technical investigations, product lifecycle management, and regulatory support activities.Strong 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.Experience leading technical assessments supporting product, supplier, manufacturing, quality, and lifecycle decisions in a regulated environment.Demonstrated ability to influence technical strategy and decision-making across cross-functional teams and external partners without direct authority.Strong written and verbal communication skills, including the preparation and review of technical assessments, investigation reports, risk analyses, regulatory documentation, and presentations to senior stakeholders.Demonstrated ability to evaluate complex technical issues, apply sound scientific and engineering judgement, assess product and compliance risks, and provide technically robust recommendations.

Organizational Relationship/Scope: The Senior Manager, Combination Products reports to the Associate Director, Combination Products and operates as a senior individual contributor within the Combination Products team, which forms part of the broader Technical Operations organization. The position has no direct reports and serves as a principal technical resource for combination-product assets. The role works closely with Quality, Regulatory Affairs, Supply Chain, Manufacturing, and external partners, providing technical leadership and influencing product, quality, regulatory, and lifecycle decisions through deep combination-product expertise.

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 €75,000 - €125,000

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. Learn more at www.keenova.com .

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.

Additional information on Keenova’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)