fme Global Life Sciences specializes in delivering comprehensive business solutions with a focus on data and document migration, enterprise content management (ECM) system implementation, and business consulting services. We serve a diverse client base in the Life Sciences industry, ranging from innovative start-ups to large global pharmaceutical companies. As a recognized leader, we provide expert consulting, tailored data and document migration, and ongoing support to meet critical needs in Regulatory Information Management (RIM), Clinical, and Quality Management System (QMS) domains. Our strategic partnerships with leading ECM vendors like Veeva Vault, OpenText Documentum, Generis CARA, Ephesoft, and Alfresco enable us to offer unparalleled expertise and service to our clients.

At fme, our priority is client satisfaction, assisting them in determining the most effective ways to deploy mission-critical technologies and support their ever-evolving business growth and needs. Our ability to provide business insight as a complement to our clients’ internal expertise, combined with our capacity to execute efficiently and cost-effectively, is a key feature of our services and sets us apart from our competition.

We are seeking a highly skilled and experienced Senior Technical Lead to oversee and drive data and document migration and implementation projects for Veeva Quality for enterprise clients. This role requires deep technical expertise, strong leadership abilities, and a thorough understanding of the life sciences landscape.

As a Senior Technical Lead, you will serve as the subject matter expert, overseeing and managing all technical aspects of the project and leading the technical team. This role requires close collaboration with the Project Manager (PM) and engagement with both internal and external stakeholders, including contractors, to ensure project success. You will work in tandem with the Project Manager, Business Analysts and Technical Consultants to ensure seamless project progression, provide strategic guidance, address technical challenges, and achieve project objectives within the established constraints.

The ideal candidate will have in-depth technical expertise with Veeva Quality and the Life Sciences industry. The successful candidate will be adept at collaborating with both business and IT teams within the Quality domain. As the technical lead, you will be responsible for implementing and migrating Content Management solutions for a diverse range of Life Sciences clients, including small, medium, and large enterprises.

You will work closely with clients to understand their business objectives, translate those objectives into system requirements, and lead the successful implementation and migration of solutions. This role involves coordinating with our offshore team and partners to ensure seamless execution. A strong understanding of pharmaceutical validation, documentation practices, and relevant regulations is essential. This role demands outstanding verbal and written communication skills, with the ability to engage effectively with individuals at all levels of an organization. We seek a creative and committed individual who will thrive in and contribute to our collaborative culture.

Key Responsibilities

Project Planning: Partner with project managers and stakeholders to define project requirements, objectives, timelines, and resource efforts. Break these down into actionable work packages, ensuring they are effectively captured and tracked within development plans.
Communication and Collaboration: Serve as the liaison between the technical project team and stakeholders, including project managers, business contacts, and QA teams. Facilitate clear and effective communication, coordinate dependencies, provide timely updates, address concerns or issues promptly, and promote collaboration and teamwork.

Team Leadership and Management: Lead and manage a global team of technical consultants, including onshore and offshore employees and contractors, by cultivating a positive, collaborative, and results-oriented work environment that encourages productivity and support.
Technical Guidance: Provide technical expertise and guidance to the project team, covering key areas such as architecture and design decisions, code reviews, documentation practices, project execution standards, and best practices. Additionally, ensure the preservation of artifacts and knowledge throughout the project lifecycle.
Stakeholder Management: Engage with technical stakeholders to gather feedback, understand their requirements, and manage expectations. In partnership with the Project Manager, keep them informed about project progress, risks, and any changes in scope by providing or contributing to weekly status reports, using client-specific or standardized fme templates.
Risk Management: Identify and mitigate technical risks, challenges, and potential roadblocks, proactively communicating them to the Project Manager. Collaborate with the technical project team to gather detailed information and explore solution options for addressing these risks.
Change Management: Identify potential change orders and proactively communicate them to the Project Manager. Provide detailed technical scope definitions, estimates, and resource planning for the proposed changes.
Quality Assurance: Ensure the team adheres to quality assurance practices by working closely with QA teams to define test strategies, review test plans, and ensure adequate test coverage. Provide support in identifying and resolving defects and performance issues.
Continuous Improvement: Stay updated with the latest industry trends, technologies, and best practices and identify areas of improvement in internal processes, tools, or implementation and migration practices as well as opportunities for continuous learning and professional development within the technical project team.
Thought Leadership: Stay abreast of industry trends, emerging technologies, and market developments, and share knowledge and insights through whitepapers, blog posts, webinars, or speaking engagements.
Pre-sales Support: Support the business development and account management teams by providing technical expertise during the pre-sales phase. Collaborate with these teams to understand client requirements, develop tailored solutions and estimates, and contribute input to proposals.

Education: Bachelor’s or Master’s degree in Computer Science, Information Technology, Life Sciences, or a related field.
Experience: Minimum of 8 years of experience in data and document migration, ECM implementation, or related fields, with at least 3 years in a leadership role within the life sciences industry. Extensive experience in architecting, installing, designing, implementing, configuring, and troubleshooting ECM systems and applications.
Technical Skills: Advanced experience in Veeva Vault Quality (QMS and QualityDocs), data and document migration tools, SQL, XML, and scripting languages. Experience with cloud-based solutions as well as on-premise solutions.
Regulatory Knowledge: Strong understanding of life sciences regulations and compliance requirements, including experience with validation processes as well as with GxP-validated systems, processes, and documentation requirements.
Leadership Abilities: Proven track record of leading technical teams and managing complex projects, with excellent problem-solving and decision-making skills.
Problem-Solving and Prioritization Skills: Strong critical thinking, analytical, problem-solving, and conflict-resolution skills, with a client-focused approach, along with the ability to multitask and prioritize effectively in a fast-paced environment.
Communication: Strong verbal and written communication skills, with the ability to effectively convey technical concepts to non-technical stakeholders and build strong relationships with both internal and external teams. Proven consultative skills with a track record of effectively guiding clients.
Globalization: Experience working with clients across international markets. Demonstrated success in managing globally distributed technical project teams, including collaboration with offshore resources and external providers.
Must be authorized to work in and live in US, preferable on the east coast due to client scheduling.

Medical, Dental & Vision plans
401k with company match
Life Insurance, Short & Long-term Disability Plans
Paid Time Off (Vacation, Sick/Personal & 10 Paid Holidays)
Employee Referral Program
Training & Development & Company Retreats
Wellness Resources/Employee Assistance Program

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fme US, LLC

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Senior Technical Lead - Veeva Quality