QC Operations Lead (Associate Director)

Overview

The QC Operations Lead (Associate Director) is pivotal in upholding exceptional standards of quality, regulatory adherence, and operational excellence within WuXi Biologics' QC function. This senior role holds overarching responsibility for managing QC instruments and equipment, computer systems, sample handling, project coordination, and ensuring compliance with QC protocols. Working intimately with senior leaders across the organization and aligning with global QC teams, this position drives local QC strategy and business planning.

Key Responsibilities

• Participate as a critical member of the QC leadership in WuXi Biologics Ireland, actively contributing to strategic planning and ensuring collaborative leadership to meet business goals.
• Collaborate closely with senior leaders to align QC practices with organizational targets and objectives.
• Represent the local QC organization professionally, liaising extensively with corporate counterparts and business leaders.
• Support the design, construction, and commissioning phases of a new drug substance production facility from a QC standpoint.
• Build and nurture a world-class Biologics QC Operations team by planning, recruiting, coaching, and training a team of 15-20 members.
• Oversee QC instruments and equipment management including installation, qualification, calibration, and maintenance schedules.
• Manage control systems such as LIMS, Empower, ECM, ELN, and serve as QC representative for GMP computer programs including Master Control, Trackwise, and Maximo.
• Supervise QC Project Leads who interface between QC, clients, and other stakeholders to ensure timely, high-quality project support.
• Monitor QC compliance by tracking deviations and staying updated on local and global regulatory requirements.
• Lead authorship and review of technical documents including SOPs, testing protocols, product specifications, and expiry documentation.
• Act as technical lead for deviations, change controls, and Corrective and Preventive Actions (CAPAs).
• Represent QC Operations during regulatory inspections, internal and client audits.
• Promote routine operational communication and collaboration ensuring all startup and ongoing operations follow safety protocols.
• Encourage cross-site knowledge sharing to strengthen global QC collaboration.
• Stay current with Good Manufacturing Practices and pursue continuous process improvements and operational excellence initiatives.
• Adapt to additional responsibilities as assigned by the QC Director and serve as a role model upholding corporate values and site behavior commitments.

Candidate Profile

• Educational background: Minimum university degree in a scientific or quality discipline; preferred qualifications include a Ph.D. with 5-8 years' experience or a Master’s with 7-10 years in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or related fields.
• Proven experience establishing QC departments and teams in greenfield environments is ideal.
• Strong expertise in sample management processes including logging, disposition, inventory audits, and response to temperature excursions.
• Comprehensive knowledge of maintenance, calibration, and requalification procedures for QC instruments, and coordination of repairs and equipment calibration.
• At least 15 years in a Quality Control environment under GMP regulations with multidisciplinary exposure, emphasizing QC operations.
• Experienced with LIMS, Empower, ECM, Master Control, Trackwise, Maximo, and proficient in Microsoft Office products including Word, Excel, PowerPoint, Visio, and Project.
• Demonstrated management and supervision skills, effectively handling personnel schedules and shifting priorities.
• Experience with regulatory inspections, internal and external audits strongly preferred.
• Experience in Contract Manufacturing Organizations (CMOs) is advantageous.
• Thorough understanding of FDA/EMA regulation, ICH guidelines, and GMP standards relevant to biologics/pharmaceuticals.

Personal Attributes

• Excellent communication and interpersonal skills, both verbal and written.
• Strong critical thinking, troubleshooting, and problem-solving capabilities.
• Self-motivated and organized with meticulous attention to detail.
• Adaptability to fast-paced environments and ability to manage multiple priorities simultaneously.
• Results-driven with robust leadership and management qualities.

Additional Information

• Up to 15% travel domestically and internationally is expected.
• This role is integral to the organizational growth and transformation at WuXi Biologics Ireland, offering an opportunity to play a key part in shaping the QC operations landscape.