Compass Pathways · 2 days ago

Senior Manager, Business Systems (Quality)

New York, NY

Full-time

Onsite

Senior Level

$130K/yr - $190K/yr

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BiotechnologyHealth Care

Growth Opportunities

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Responsibilities

Represent and advocate for IT needs within the Quality Assurance organization

Provide technical leadership for the eQMS platform: MasterControl

Track and manage Quality Assurance IT projects and initiatives

Develop project plans, manage budgets, and coordinate project delivery

Facilitate solution implementation through pilots, testing, and training

Analyze data flows impacting clinical operations and manage solutions

Optimize solutions through their lifecycle and manage product vendors

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

EQMS systemsMasterControlGxP computer systems validationFDA regulationsICH guidelinesQuality Assurance processesBusiness case developmentSaaS vendor managementSystem engineeringData modelingInformation modelingProcess mappingPC ToolsMS ProjectMS VisioMS OfficeProblem-solvingTime managementProject leadershipCommunicationCollaborationOrganizational skillsITILITSMRapid Growth ExperienceAdaptability

Required

Knowledge of and experience with rollout, configuration, management, and support of eQMS systems. Specific experience with MasterControl is highly preferred

Bachelor's degree in computer science, Management Information Systems or related field and considerable experience in Biotech/Pharma

Solid project and time management skills—will be called upon to lead a cross functional project team in the absence of a Project Manager

Knowledge of and experience with GxP computer systems validation, applicable FDA regulations and ICH guidelines

Experience working with key Quality Assurance processes, like document control, CAPA/deviation, and audit

Ability to create compelling business cases with accurate cost and effort estimations

Ability to work well and partner with a wide range of team members: technical, business subject matter experts and stakeholders, especially under stress and with changing priorities

Experience in managing external SaaS vendors through selection, contract negotiation, implementation, and ongoing maintenance/support

Strong understanding of basic system engineering and data and information modeling, data and process mapping

Ability to work effectively in a collaborative team environment where results are achieved through influence and the incorporation of multiple points of view

Excellent organisational skills, sufficient to multi-task in an extremely fast-paced environment with changing priorities

PC Tools skills: MS Project, MS Visio/Flow Charting, MS Office