Senior Quality Systems Engineer – GMP Change Control

Compunnel Inc.; Utah; On-site; USD 110,000 - 160,000; Full time

Job summary

Compunnel Inc. in Utah seeks a senior-level Quality Systems professional with strong pharmaceutical manufacturing and GMP/Compliance experience to support and improve site QMS, oversee Change Control, and drive continuous improvement and regulatory compliance initiatives.

You will review and approve quality documentation, collaborate with Manufacturing, MSAT, QC, R&D, Supply Chain, and Operations, and participate in inspections by FDA/EMA or other authorities while leading corrective actions and

Qualifications

• Bachelor's degree in Biology, Chemistry, Pharmaceutical Sciences, or related discipline preferred.
• 7+ years of relevant pharmaceutical industry experience or equivalent.
• 3+ years of Quality Assurance experience within pharmaceutical production.
• Minimum 5 years of Quality Systems/GMP experience.
• Strong experience with Change Control and Quality Documentation.
• Experience reviewing/approving SOPs, protocols, risk assessments, and quality records.
• Strong technical writing and communication skills.
• Ability to work independently and make sound quality/compliance decisions.
• Experience with Veeva, TrackWise, EDMS, ERP and/or LMS preferred.
• Pharmaceutical manufacturing experience with various dosage forms preferred.
• Experience supporting FDA/EMA or other Health Authority inspections preferred.

Responsibilities

• Manage and oversee Change Control activities from initiation through implementation and approval.
• Host/support Change Control Review Boards.
• Review and approve SOPs, protocols, risk assessments, and quality records.
• Maintain and improve pharmaceutical Quality Management Systems (QMS).
• Support GMP, FDA, EMA/MHRA and other regulatory compliance requirements.
• Participate in internal, partner, and regulatory inspections/audits.
• Support Annual Product Reviews, quality metrics, trending, and continuous improvement projects.
• Provide quality/documentation support for facility shutdowns and other major site initiatives.
• Collaborate with Manufacturing, MSAT, QC, R&D, Supply Chain, and Operations.
• Identify compliance gaps and independently drive corrective actions and process improvements.

Skills

Change Control

Quality Documentation

QMS

GMP Compliance

Regulatory Inspections

Technical Writing

Independent Decision Making

Education

Bachelor's degree in Biology/ Chemistry/ Pharmaceutical Sciences

Tools

Veeva

TrackWise

EDMS

ERP

LMS

Job description

Compunnel Inc. in Utah seeks a senior-level Quality Systems professional with strong pharmaceutical manufacturing and GMP/Compliance experience to support and improve site QMS, oversee Change Control, and drive continuous improvement and regulatory compliance initiatives.

You will review and approve quality documentation, collaborate with Manufacturing, MSAT, QC, R&D, Supply Chain, and Operations, and participate in inspections by FDA/EMA or other authorities while leading corrective actions and