Business Analyst - Development Operations and Validation

The Business Analyst (BA) is a self-starter with expert-level Business Analysis capabilities, a passion for transforming healthcare, a high level of flexibility, and a commitment to delivering value to patients. They must be an effective negotiator, leader, and communicator when partnering with client/client’s global Technical Operations business units, including Manufacturing, Quality, Supply Chain, Technical Development, and Technical Regulatory, as well as with IT cross-functional teams.

The BA will work closely with one or more internal client/client business organizations and the IT domain organizations to understand strategic drivers and tactical needs. This will ensure that IT implementation teams can provide products that meet business needs with high business value, stability, usability, and scalability. They will be assigned to the Advanced Therapies Product Line of the Technical Operations Domain. Their focus area is the Development Operations and Validation team of the Individualized Therapies/Cell Therapies (ITCT) Agile Release Train (ART). The successful candidate will contribute their BA capabilities, expert knowledge of Agile release trains, development operations, extensive experience in GxP-compliant working environments, and mastery of Computer System Validation (CSV) required to deliver regulated GMP IT products and capabilities.

Responsibilities:

• Analyze/document current and future business process models, high-level requirements (scope), and detailed functional specifications or agile user stories with acceptance criteria.
• Guide and support other Business Analysts and Product Owners as they develop the detailed requirements or agile user stories with acceptance criteria.
• Lead/contribute to all acceptance testing efforts, including SAT, UAT, dry runs and other types of testing.
• Supporting the implementation of IT solutions that require GxP validation.
• Effectively communicate with the IT development team and the extended project team.
• Independently make BA project decisions with impact at the process, organization, or program level.
• Tailor messaging to different target audiences and choose appropriate communication channels.
• Act as a Lead BA and/or Product Owner Delegate on large/global or multi-portfolio initiatives/projects.
• Actively look for opportunities to improve how business processes are executed.

Qualifications:


• Bachelor’s degree in engineering, information technology, or science with 5-7 years of related experience.
• Experience with technical development, material sciences, or manufacturing in a pharmaceutical company.
• Knowledge of solutions such as LIMS, ELN, Quality Systems (Veeva), but also data management solutions.
• Experience in and understanding of application development methodology, including Agile and Waterfall approaches, process modeling and re-engineering, user acceptance testing, organizational change management, and large-scale/global system implementations.
• Proven leadership abilities and emotional intelligence.
• Demonstrated success in handling initiatives of high complexity, high profile, and large scale/global programs.
• Proven skills in relationship building, influencing, customer focus, decision-making, and problem-solving.
• Demonstrated ability to learn the business in unfamiliar areas quickly and remain curious.
• Excellent communication (written and oral) and presentation skills; solid business acumen; and well-honed influencing skills are essential.
• Self-motivated and team-oriented; able to work both autonomously and effectively as part of a geographically dispersed team.
• Comfortable working with Google collaboration tools, JIRA and Client ALM.

Strong Preference For:
• Experience with supporting the implementation of IT solutions that require GxP validation.
• Experience with working as a member of an agile development team, proficiency with agile methodologies and concepts such as User Stories, Story Maps, Personas, etc