全球制药专家
Global Pharmaceutical SME
制药制造与监管专家将提供行业洞察和监管机构的专业知识、市场见解、制造期望以及客户可信度，以支持Flowserve的制药业务增长计划。
该职位将领导制药市场战略，培育与全球制药制造商和生物工艺OEM的战略关系，并将严格的制药市场需求转化为商业和产品优先事项。
作为生命科学制造、就地清洁/就地灭菌（CIP/SIP）应用及cGMP合规性的关键专业技术权威，该专家推动Flowserve全球客户群的市场准备、监管对齐和技术采纳。
理想的候选人应具备监管机构、卫生当局、认证机构或高级监管质量领导职位的经验，涉及制药制造、检查准备、质量体系、验证、供应商期望和监管参与等方面。
职责
- 客户之声：作为客户的首要代表，将制药应用、质量、监管和运营需求转化为可执行的业务和产品开发优先事项。
- 监管指导：为跨职能的工程、销售和运营团队提供关于制药和监管机构期望的建议，包括cGMP、验证、供应商资质、文件、可追溯性、质量体系成熟度、监管风险考量和变更控制。
- 商业化与产品策略：根据客户反馈、市场趋势和上市准备要求，为产品开发路线图和商业化计划提供关键输入。
- 市场执行：为制药、生物制药和生物工艺应用制定并实施针对性的市场策略。
- 利益相关者参与：识别并培养与制药制造商、药物研发实验室、生物工艺OEM、模块集成商、大学和行业合作伙伴的战略关系。
- 技术评估：支持客户试验、技术评估、参考安装、行业会议和全球路演。
- 跨职能上市计划：与销售、产品管理、工程、运营、供应链和市场营销合作，制定上市计划、销售赋能材料和客户支持方案。
查看英文原文
The Pharmaceutical Manufacturing and Regulatory Expert will provide industry-informed and regulatory-body expertise, market insight, manufacturing expectations, and customer credibility to support Flowserve’s pharmaceutical growth initiative.
This role will lead pharmaceutical market strategy, cultivate strategic relationships across global pharmaceutical manufacturers and bioprocess 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 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.
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.
EDUCATION
· Bachelor’s degree in Engineering, Life Sciences, Business, or a related field required. Advanced degree (Master's, MS, PhD) or equivalent relevant experience preferred.
The pay range for this role is $172,930.93 - $259,518.35 per year.Originally posted on Himalayas