Quality Systems Engineer GOSDC

We are seeking a senior-level Quality Systems professional with strong pharmaceutical manufacturing and GMP/Compliance experience. This role will support and improve site Quality Management Systems (QMS), oversee Change Control activities, review and approve quality documentation, and support continuous improvement and regulatory compliance initiatives.

Key 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
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• 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.

Requirements

• 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
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• Strong experience with Change Control and Quality Documentation
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• 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, Track Wise, EDMS, ERP and/or LMS preferred.
• Pharmaceutical manufacturing experience with various dosage forms preferred.
• Experience supporting FDA/EMA or other Health Authority inspections preferred.

Compunnel Inc. is an Equal Employment Opportunity (EEO) employer committed to fostering an inclusive, diverse, and equitable workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex, sexual orientation, gender identity or expression, national origin, citizenship status, age, disability, protected veteran status, marital status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

As a global workforce solutions provider, Compunnel values diversity of thought, background, and experience, and believes an inclusive workforce strengthens innovation and client success.