Pharmaceutical Manufacturing Quality and Compliance SME (EIDA, Veeva, Kneat)
Our client is seeking an EIDA SME to join their Quality and Compliance pharmaceutical manufacturing team. The right candidate will be an EIDA, Veeva, or Kneat SME.
Location: Richmond, VA
Contract 1-3 years
This is a great opportunity to join a global company with multiple site expansions and buildouts. You will play a critical role in strengthening EIDA system documentation, ensuring FDA compliance, and driving quality-focused project execution across the full project lifecycle. This is a high-impact role requiring deep expertise in EIDA systems, pharmaceutical quality standards, and project compliance within regulated environments.
Qualifications
- 8+ years of experience in pharmaceutical or biotech environments (GxP-regulated)
- Proven experience as an EIDA SME or strong expertise in VEEVA or KNEAT systems within pharma manufacturing
- Deep understanding of:
- FDA regulations (21 CFR Part 11, cGMP, etc.)
- Project compliance and validation standards
- Quality systems and documentation practices
- Demonstrated experience supporting full projectlifecycle:
- Design → Construction → CQV → Validation
- Strong background in:
- Quality documentation development & remediation
- Audit readiness and compliance execution
- Ability to operate onsite and collaborate cross-functionally with multiple stakeholders
- Experience in large-scale capital projects / site expansions
- Familiarity with digital systems, automation, or data integrity (EIDA-related platforms)
Key Responsibilities
- Serve as the EIDA SME for quality and compliance across site projects
- Lead and remediate EIDA-related documentation gaps, ensuring alignment with FDA and internal quality standards
- Own and manage EIDA system documentation (URS, FS, DS, test protocols, traceability, etc.)
- Provide subject matter expertise throughout the full projectlifecycle:
- Design review & verification
- Construction support
- Commissioning & Qualification (CQV)
- Validation and handover
Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.
If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.
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