Overview
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.
Responsibilities
• 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.
Qualifications
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)