Digital Validation Product Analyst - Digital Quality Operations

$83,100 - $130,900/Yr

Merck KGaA Darmstadt Germany - West Point, PA

Full-time - Mid Level

Onsite - West Point, PA

Chemical Manufacturing

About the position

The position available is in the Digital Manufacturing Division organization, specifically in Digital Quality and Labs, Digital Quality Operations, Content Management Product Line Team. This team is responsible for designing, implementing, and maintaining Digital Operations of critical Quality Management System (QMS) processes, including Content Management and Digital Validation. The Digital Validation Product Analyst will provide close support for the Digital Validation Product. In this role, you will ensure that released products meet business needs and compliance requirements and help the team achieve its goals. You will define and prioritize requirements (stories) in the backlog and accept requirements (stories) as completed. Additionally, you will work with stakeholders to understand and communicate user needs and assist in Digital Product discovery activities. You will play a critical role in planning, designing, and testing activities and engaging support teams for Good Automated Manufacturing Practice (GxP) products. You will also work closely with the Production Support (AMS) team to help sustain the production system. The role requires collaboration with global stakeholders in our Manufacturing Division, Digital Manufacturing Division, Digital Quality Operations, and IT.

Responsibilities

• Partner with the Content Management Product Owner to understand, prioritize, and develop product roadmaps and strategically aligned IT solutions that deliver maximum business value.
• Ensure that Digital Solutions are true enablers to standard processes and ensure that all enhancements are consistent with this global design.
• Experience in defining requirements, translating them between the development and business-facing teams, and documenting them for GxP systems.
• Drives continuous product discovery to understand user needs and translate that to solutions and product backlog.
• Creates, maintains, and continuously prioritizes the product backlog to maximize value delivery and long-term sustainability.
• Develop and convey accurate and realistic project plans, resource estimates and timelines in alignment with prioritized business requirements.
• Ensure all IT systems are designed, built, and operated in an SDLC-compliant manner and promote the effective use of IT standards and tools.
• Establish strong working relationships with business and technology leaders.
• Monitors and optimizes product's total cost of ownership (TCO).
• Develops and monitors metrics of the Digital Product.
• Drives release and support planning and execution.
• Connects delivery squad(s) with the customers and facilitates direct communication.
• Self-motivated, value-oriented with a mindset of continuous learning.

Requirements

• High school diploma required; B.A./B.S. in a scientific or technical discipline (such as computer science, engineering, biology, chemistry, etc.) preferred.
• Four (4) + years of demonstrated hands-on experience designing and implementing Digital solutions in complex enterprise environments.
• Ability to partner with business stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs.
• Ability to effectively collaborate and communicate with a variety of audiences and stakeholders, including, but not limited to, business leaders, IT peers, and colleagues worldwide.
• Comfortable challenging the status quo and possessing the ability to influence and manage stakeholders.
• Ability to be flexible and handle multiple tasks well, under pressure.
• Ability to lead and influence others outside of a direct reporting relationship.

Nice-to-haves

• Pharmaceutical experience preferred.
• Knowledge of Kneat or similar paperless validation management software.
• Quality/Regulatory and Digital Enablement experience.
• Demonstrated leadership in achieving shared objectives in a matrix organization, managing cross-divisional initiatives, and cross-functional teams in an extremely dynamic environment.
• Experience with digital technologies such as artificial intelligence, IoT, data analytics, and automation, as well as cross-discipline in Application Development and Business Intelligence, analytics, integration, support, engineering, and architecture.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days