Overview In this role you lead the Quality Engineering team within Operations, guiding quality engineers across manufacturing processes, validation, and compliance activities. You ensure adherence to Client Quality Systems and cGMP requirements, while steering risk-based decisions and resource management. You collaborate with cross-functional partners to support new and existing processes, tech transfer, and market expansion. You will shape quality strategies, escalate risks, and report status to leadership, enabling robust product quality and regulatory compliance. This position offers a meaningful opportunity to impact manufacturing quality on a global scale.
Responsibilities- Lead and develop a team of quality engineers for manufacturing quality oversight and compliance activities
- Provide functional leadership for quality engineering across processes, equipment, utilities, facilities, and systems
- Direct quality engineering efforts for base operations, development, tech transfer, and market expansion projects
- Ensure validation/qualification strategies, protocols, and lifecycle activities meet Quality Systems and cGMP
- Review and address quality/compliance gaps, driving risk-based actions
- Partner with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to enable compliant implementations
- Guide risk management activities and mitigation planning
- Oversee or support qualification/validation for equipment, processes, cleaning, utilities, computerized systems, and methods
- Identify, escalate, and resolve quality issues impacting product quality and regulatory compliance
- Communicate status, risks, and recommendations to management and executives, managing resources and budget to enable efficient execution
Key requirements- Minimum 8+ years in Manufacturing, QA, QC, or R&D in pharmaceutical/biologics/devices/chemical industries
- 4+ years of supervisory/technical leadership experience
- Bachelor's degree in a relevant field; advanced degrees highly desired
- Working knowledge of physical/chemical properties of products and raw materials
- Familiarity with statistical quality systems, electronic document management, and laboratory information management
- Understanding of Quality policies, cGMP, and regulatory requirements
- Strong people management and cross-functional collaboration skills
- Excellent oral and written communication skills
- Demonstrated strategic vision and leadership in building high-performing teams
- Ability to influence stakeholders and manage cross-functional projects
- strong communication
- leadership
- cross-functional collaboration
- Quality Systems and cGMP compliance
- validation and qualification of equipment, processes, and systems
- risk management and mitigation
