Senior Quality Systems Engineer

Quick Facts

• Role: Sr Quality Systems Engineer

Description

Support and execute the site Quality Management System (QMS), including documentation management, Continuous Improvement, cleaning and computer system validation, and equipment/facility/utility qualification. Oversee change management, Annual Product Review, and quality metrics/data trending to ensure adherence to cGMP and relevant regulations. Represent Quality Systems leadership and collaborate with internal and external stakeholders, including during inspections and audits.

Responsibilities

• Develop, support, and execute annual quality/compliance projects delivering site metrics, KPIs, and goals
• Host the Change Control Review Board and manage change control from initiation through approval
• Provide records management and change control expertise to support compliant shutdown planning/execution
• Ensure facility operations meet requirements such as GMP/cGMP and applicable regulatory standards (e.g., FDA, MHRA, EMEA, OSHA, EPA, DEA)
• Participate in partner, internal, and regulatory inspections and audits
• Review and approve SOPs, protocols, risk assessments, and other quality records
• Improve and maintain quality systems to ensure compliance with cGMPs, company policies/procedures, and governmental regulations
• Support cross-functional quality projects and corporate standard assessments
• Complete required training and maintain compliance with all assignments
• Maintain safe work practices in line with company policies, cGMP, and SOPs

Requirements

• Bachelor’s degree (preferably in biology, chemistry, or related field) or equivalent education/experience
• Minimum 7 years relevant progressive pharmaceutical industry experience
• Minimum 3 years Quality Assurance experience in pharmaceutical production
• Direct experience (preferred) with manufacturing various pharmaceutical dosage forms
• Direct experience (preferred) with health authority inspections (e.g., FDA/EMA, ANVISA)

Benefits

• Comprehensive health insurance (medical, dental, vision, prescription) starting day one (if enrolled)
• 401(k) with employer match up to 6% and annual defined contribution up to 3.75%
• Paid time off (vacation, sick/safe time, caretaker time, holidays)
• Company-paid life and disability insurance
• Additional benefits including EAP, Employee Stock Purchase Plan, tuition assistance, flexible spending accounts, HSA, lifestyle spending account, volunteer time off, paid parental leave (if eligible), family building benefits, virtual physical therapy, and more