Quality Systems Engineer -- GOSDC5912373

Position Summary:

The Sr. Quality Systems Engineer will support and maintain Quality Management Systems (QMS) within a pharmaceutical manufacturing environment. This position focuses on GMP compliance, change control, quality documentation, continuous improvement, validation, qualification, metrics, and quality system management.

The engineer will oversee change management activities, support Annual Product Reviews, monitor quality metrics and data trends, and review and approve quality documentation. The role works closely with Manufacturing, Operations, MSAT, R&D, Supply Chain, Quality Control, and other internal and external stakeholders to ensure compliance and improve site processes.

This is a senior-level individual contributor role requiring someone who can work independently, exercise sound judgment, solve complex problems, and make higher-level quality and compliance decisions. Management experience is not required.

Key Responsibilities:

• Manage and support Quality Management Systems (QMS) in a pharmaceutical manufacturing environment.
• Lead and oversee Change Control activities from initiation through implementation, review, and final approval.
• Host and facilitate the Change Control Review Board.
• Review and approve SOPs, protocols, risk assessments, quality records, and other controlled documents.
• Support GMP compliance and ensure quality systems meet company policies and regulatory requirements.
• Support FDA, EMA/MHRA, and other regulatory or partner inspections and audits.
• Support facility shutdown planning and execution through compliant records management and change control.
• Manage and support continuous improvement and quality/compliance projects.
• Support process validation, cleaning validation, computer system validation, equipment qualification, and facility/utility qualification.
• Oversee and support Annual Product Reviews.
• Monitor quality metrics, KPIs, and data trends and identify opportunities for improvement.
• Develop and execute annual quality projects aligned with site goals and business objectives.
• Collaborate with Operations, Manufacturing Science & Technology, R&D, Supply Chain, Quality Control, and other departments.
• Identify quality and compliance gaps and recommend improvements.
• Support cross-functional quality initiatives and corporate quality assessments.
• Help drive process improvements and organizational change.
• Maintain accurate documentation and complete required training and compliance activities.
• Follow CGMP, SOP, safety, and regulatory requirements.
• Perform other quality-related duties as assigned.

Required Qualifications:

• Minimum 5 years of experience in Quality Systems and/or GMP compliance within a pharmaceutical manufacturing environment.
• Strong experience with Quality Systems and Quality Assurance.
• Experience with Change Control and quality documentation management.
• Experience reviewing and approving:
• SOPs
• Protocols
• Risk Assessments
• Quality Records
• Strong technical writing and documentation skills.
• Strong problem-solving, judgment, and decision-making abilities.
• Ability to work independently with minimal supervision.
• Strong cross-functional communication and collaboration skills.
• Ability to manage multiple priorities and quality/compliance projects.

Preferred Qualifications:

• Bachelor's degree in Biology, Chemistry, Life Sciences, or another scientific discipline, or equivalent education and experience.
• 7 years of progressive pharmaceutical industry experience preferred.
• 3 years of Quality Assurance experience within pharmaceutical production preferred.
• Experience manufacturing different pharmaceutical dosage forms.
• Experience supporting FDA, EMA, ANVISA, MHRA, or other Health Authority inspections.
• Project management experience.
• Advanced presentation skills.
• Experience with TrackWise, Veeva, EDMS, ERP systems, LMS, and Microsoft Office.

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.