Location: GB_GreatBritain_WFH
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.
Additional Locations: Northern Ireland, United Kingdom
Job description provided by Flowserve.
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