Business Architect

at Merck in Dover, Delaware, United States

The Digital Quality Operations team within DQ&L is tasked with simplifying the current complex QMS technology stack consisting of multiple technologies into an integrated unified quality system in order to improve the workflow, reduce high overhead costs, enhance user experience and unlock the power of data.

The Change Control Business Architect – Associate Director (AD) will ensure that change control capabilities meet the aspirations of the DQO team and provide value to the business community. The incumbent will serve as a liaison between our technology partners and key stakeholders within the business. Additionally, you will be accountable for identifying opportunities to grow and improve the IT technical landscape while simultaneously ensuring consistent performance of existing IT applications. The incumbent is expected to work collaboratively with stakeholders across the global change control landscape and to provide oversight to less senior team members, as needed.

Education:

+ Minimum of a B.A./B.S. in a scientific or technical discipline (such as computer science, engineering, biology, chemistry, etc.). Pharmaceutical experience preferred.

Primary Tasks/Key Responsibilities

+ Partner with Change Control Product Owner in the understanding, prioritization and development of strategically aligned IT solutions which deliver maximum business value.

+ Ensure that Change Control IT platforms are true enablers to standard process and ensure that all enhancements are consistent with this global design.

+ 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.

+ Allies with other process and topics owners across the company globally to align change control, batch disposition and regulatory/ CMC process in an effort to accelerate supply to patients.

+ Lead the end-to-end development of systems and technology blueprints and roadmaps.

+ Establish strong working relationships with business and technology leaders in order to align investment planning, portfolio planning and execution with these roadmaps and architectures.

+ Drive investment decisions with a mindset to optimize total cost of ownership with delivered business value.

+ Promotes a common approach to the delivery of divisional business objectives.

Required Experience and Skills:

+ Min. 5-10 years of Pharmaceutical Industry experience, ideally in Change Control processes. Quality/Regulatory and Digital Enablement experience strongly preferred.

+ Working hands-on knowledge of Change Control processes and technical applications in the pharmaceutical industry

+ Demonstrated ability to partner with business stakeholders and navigate across conflicting priorities to balance critical tactical and strategic needs ?

+ Strategic thinker, with demonstrated ability to work in a broad and top-down manner with a fair amount of ambiguity at the center ?

+ Demonstrated ability to effectively collaborate and communicate with a variety of audiences and stakeholders including, but not limited to executive management, business leaders, IT peers, and colleagues worldwide ?

+ Demonstrated leadership in achieving shared objectives in a matrix organization, managing cross-divisional initiatives, and cross-functional teams in an extremely dynamic environment?

+ Demonstrated ability to envision the future and rally the organization / people towards a common goal?

+ Comfortable challenging the status quo and possesses ability to influence and manage stakeholders

+ The ability to be flexible and handle multiple tasks well, under pressure.

+ Ability to lead and influence others outside of a direct reporting relationship.

+ Broad organizational awareness and knowledge of touch points/interdependencies

#eligibleforerp

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