Your Role and Impact
The Pharmaceutical Manufacturing and Regulatory Subject Matter Expert (SME) will provide industry-informed and regulatory-body expertise, market insight, manufacturing expectations, and customer credibility to support Flowserve’s pharmaceutical growth initiative.
This role is a remote role and will lead pharmaceutical market strategy, cultivate strategic relationships across global pharmaceutical manufacturers and bioprocess Original Equipment Manufacturers (OEMs), and translate rigorous pharmaceutical-market requirements into commercial and product priorities.
Serving as a key technical authority across life sciences manufacturing, clean-in-place/steam-in-place (CIP/SIP) applications, and current Good Manufacturing Practice (cGMP) compliance , this subject matter expert drives market readiness, regulatory alignment, and technology adoption across Flowserve’s global customer base.
Ideal candidates bring extensive experience with a regulatory body, health authority, notified body, or senior regulatory-quality leadership role involving pharmaceutical manufacturing, inspection readiness, quality systems, validation, supplier expectations, and regulatory engagement and are located in Ireland.
Key Responsibilities
- Voice of the Customer: Serve as the primary voice of the customer, translating pharmaceutical application, quality, regulatory, and operational requirements into actionable business and product development priorities.
- Regulatory Guidance: Advise cross-functional engineering, sales, and operations teams on pharmaceutical and regulatory-body expectations, including cGMP, validation, supplier qualification, documentation, traceability, quality-system maturity, regulatory risk considerations, and change control.
- Commercialization & Product Strategy: Provide critical input to product-development roadmaps and commercialization plans based on customer feedback, market trends, and launch-readiness requirements.
- Market Execution: Develop and implement targeted market strategies for pharmaceutical, biopharmaceutical, and bioprocess applications.
- Stakeholder Engagement: Identify and nurture strategic relationships with pharmaceutical manufacturers, drug-development laboratories, bioprocess OEMs, skid integrators, universities, and industry partners.
- Technical Evaluations: Support customer trials, technical evaluations, reference installations, industry conferences, and global roadshows.
- Cross-Functional Go-to-Market: Partner with Sales, Product Management, Engineering, Operations, Supply Chain, and Marketing to develop go-to-market plans, sales enablement materials, and customer-value propositions.
- Market & Competitive Intelligence: Conduct competitive benchmarking and market analyses to identify emerging growth opportunities, target segments, priority accounts, and strategic partners.
- Channel & OEM Development: Support OEM and channel partner development, focusing on early design-in opportunities and partner qualification.
- Executive Alignment: Communicate strategic priorities, progress, risks, and recommendations directly to executive leadership and cross-functional stakeholders.
Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Business, or a related field required. Advanced degree (Master's, MS, PhD) or equivalent relevant experience preferred.
- Several years of experience in the pharmaceutical, biopharmaceutical, biotech, bioprocess, or regulated life-sciences industry.
- Knowledge of FDA/EMA expectations and global pharmaceutical regulations.
- Strong understanding of pharmaceutical manufacturing requirements and regulatory expectations
- Demonstrated experience translating customer and market needs into product, commercial, or operational requirements.
- Experience working cross-functionally.
- Proven ability to engage credibly with technical and commercial stakeholders at pharmaceutical manufacturers, OEMs, system integrators, and other industry partners.
- Strong knowledge of the pharmaceutical / biopharmaceutical market, including customer decision drivers, operational challenges, and application requirements.
- Ability to develop and communicate market strategies, value propositions, and go-to-market recommendations.
- Fluent English and willingness to travel internationally.
Preferred Qualifications
- Existing network in pharma, biotech, Contract Development and Manufacturing Organization (CDMO), or bioprocess markets
What We Can Offer You
At Flowserve, you'll find a range of options to fit your, and your family's, needs. We want to provide our team with the right resources to invest in your physical, mental and financial well-being no matter where you sit or what stage of life you're in.
