We are seeking a highly motivated and detail-oriented professional with a strong engineering background to join our team in a GMP-regulated environment. This role is ideal for someone who thrives at the intersection of technical problem-solving and quality compliance. The ideal candidate will bring a solid understanding of engineering principles, coupled with hands-on experience in regulated manufacturing settings, to support continuous improvement, process reliability, and adherence to GMP standards across operations.

• Provide strategic leadership and direction to the Quality Management System (QMS), ensuring alignment with customer GMP requirements and Corporate Quality standards.
• Drive the development and maturity of the QMS and the Quality team, embedding a quality-driven culture that supports the company’s mission, vision, and goals.
• Foster a customer-centric culture built on compliance, product integrity, and.
• Establish and maintain a scalable, compliant quality framework and governance model that adheres to Corporate Quality expectations and supports sustainable growth across operations.
• Develop, implement, and maintain robust quality policies and standard operating procedures (SOPs) in accordance with applicable GMP, Corporate Quality guidelines, and regulatory requirements.
• Promote a culture of continuous improvement, utilizing risk-based approaches and quality metrics to enhance product quality, process efficiency, and regulatory compliance in alignment with Corporate Quality initiatives.
• Continuously evaluate and enhance the QMS to ensure ongoing compliance with Corporate Quality systems, applicable standards (e.g., 21 CFR Parts 210/211, 820), and global regulatory requirements.
• Collaborate with cross-functional teams (e.g., Manufacturing, Supply Chain, R&D) to align quality objectives and ensure consistent execution of quality initiatives.
• Provide independent oversight and authority for product quality decisions, including batch disposition, deviation management, and CAPA review in accordance with Quality procedures.
• Represent Quality across all levels of the organization, including the Leadership Team, to drive alignment with Corporate Quality strategy and support strategic decision-making.
• Ensure timely identification, escalation, and resolution of quality issues, and provide site senior management with risk-based assessments and remediation plans.
• Serve as the lead representative for external audits and inspections (e.g., customer, regulatory authorities), ensuring audit readiness, alignment with Corporate Quality practices, and consistency across all departments.
• Maintain up-to-date knowledge of Corporate Quality directives, regulatory trends, industry best practices, and operational processes to guide strategic quality planning and ensure global compliance across all functions.

Education / Knowledge

• Bachelor’s Degree in Engineering, Chemistry, or Biology (Required)

• Master’s Degree in Quality (Preferred)

• Strong knowledge of ISO 9001:2015 and previous versions (Required)

• Internal auditing, CAPA management, metrics, planning, customer complaints, customer response and feedback (Required)

Work Experience

• 15+ years of experience in Quality (Required)

• 10+ years of relevant experience in bioprocessing, biotech, or pharmaceutical industries (Required)

• 5+ years of experience as a functional leader of a Quality department (Required)

• Experience in leading and managing audits, inspections, and maintaining successful relationships with regulatory agencies (Required)

• Experience in reporting and presenting to senior management MRM, MRB, QBR (Required)

• Experience in managing teams.

Skills and Competencies

• Thorough knowledge of applicable regulations (Required)

• Excellent verbal and written communication skills; ability to mediate, build consensus, and resolve issues calmly and effectively (Required)

• Strategic thinking (Required)

• Excellent analytical and problem-solving skills (Required)

• Methodical approach to problem solving with a strong commitment to quality (Required)

• Attentive to detail while maintaining a big-picture perspective (Required)

• Process-oriented and metric-driven (Required)

• Customer-focused (Required)