Digital Validation Product Analyst - Digital Quality Operations

Job Description

The position available is in the Digital Manufacturing Divisionorganization, 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 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 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.

Primary Tasks/Key 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.

Education:

• High school diploma required.
• B.A./B.S. in a scientific or technical discipline (such as computer science, engineering, biology, chemistry, etc.) preferred.

Required Experience:

• 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.

Preferred Experience:

• 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.

MSJR

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Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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Expected salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listedhere.

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Relocation:No relocation

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