Digital CMC Consultant
New
Q
QbDVision, Inc.Life Sciences
United States. Dublin, County Dublin, IrelandFull-TimeSenior
Salary not disclosed
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Job Details
- Experience
- 10+ years
- Required Skills
- Quality AssuranceChange Management
Requirements
- Bachelor’s degree in science, business, or equivalent working experience.
- 10+ years of direct experience with life sciences, software or consulting in or supporting regulated industry.
- Pharma background with CMC, QA and/or Regulatory experience.
- Familiarity with GMP manufacturing workflows (supply chain, change management, tech transfer, Validation).
- Strong analytical and problem solving skills.
- Experience working with global pharmaceutical companies.
- Customer-facing consulting experience.
- Managed relationships with executive stakeholders.
- Ability to travel up to 30%.
Responsibilities
- Lead complex workstreams and projects focused on Digital CMC across development and manufacturing.
- Analyze complex business requirements to document and implement digital CMC projects.
- Ensure technical specifications meet client-defined business outcomes.
- Execute and deliver on customer projects.
- Provide guidance and best practices to ensure customer success.
- Drive the development of Digital CMC thought leadership.
- Collaborate with senior stakeholders to define project scopes and transformational goals.
- Serve as a bridge between clients and internal Product and Engineering teams.
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