QC Manager - Raw Materials
The QC Manager - Raw Materials provides strategic leadership and operational oversight for the Raw Material Release team within Quality Control. Working closely with the Head of Quality Control, this role supports departmental strategy, business objectives, and key performance indicators.
This position manages analytical testing resources to support the timely, accurate, and compliant release of raw materials and in-process samples for GMP products. The manager leads, mentors, and develops laboratory personnel while guiding workforce planning, resource allocation, technical problem-solving, regulatory compliance, project tracking, and laboratory workflows.
The role also serves as a key liaison across Quality, Manufacturing, Supply Chain, and other business functions, maintaining clear communication about priorities, project status, and release timelines with cross-functional partners and senior leadership.
What Success Looks Like
Leadership and Team Development
• Establish strategic direction for Quality Control raw material testing activities.
• Build strong partnerships with QA, Manufacturing, MS/TS, Engineering, and Regulatory.
• Drive a culture of accountability, urgency, compliance, operational excellence, transparency, trust, and collaboration.
• Promote data-driven decision-making and continuous improvement.
• Set clear expectations for performance, ownership, and behavior.
• Lead team planning, prioritization, workload balancing, and resource allocation.
• Coach, performance manage, mentor, and develop QC Analysts.
• Establish quality objectives aligned with site business goals and customer requirements.
Laboratory Asset Management
• Ensure laboratory compliance with GMP and Data Integrity requirements.
• Conduct routine laboratory safety audits.
• Review laboratory performance metrics and trends.
• Drive continual improvement in the maintenance and operation of analytical equipment.
• Review and approve quality-impact assessments associated with laboratory equipment qualifications.
• Oversee calibration, preventive maintenance, work-order activities, and equipment readiness when product quality, validated state, or GMP compliance may be impacted.
• Partner with Quality Assurance and Engineering to ensure equipment remains in a qualified state.
QC Investigations Management
• Lead the creation and approval of investigational testing plans for OOS investigations, OOT investigations, analytical deviations, Data Integrity investigations, and QC laboratory CAPAs.
• Ensure investigations identify root cause, product impact, and effective corrective actions.
• Partner with Quality Assurance leadership to improve investigation cycle times, laboratory compliance performance, repeat OOS review, and right-first-time performance in QC laboratory operations.
Regulatory Compliance
• Support regulatory inspections and customer audits of the QC laboratory.
• Serve as the Quality Control subject matter expert for laboratory compliance activities.
• Maintain awareness of current regulations and industry standards for analytical testing.
Capabilities and Expertise
Education and Experience
• Bachelor's, master's, or doctoral degree in Chemistry, Engineering, or a related discipline.
• Eight or more years of experience in a pharmaceutical or biotechnology analytical laboratory.
Knowledge, Skills, and Abilities
• Demonstrated knowledge of analytical equipment, processes, and practices.
• Strong attention to detail, integrity, and reliability.
• Proficiency with Word, Excel, Outlook, and PowerPoint.
• Project management, organization, technical writing, and presentation skills.
• Technical problem-solving proficiency and the ability to troubleshoot time-sensitive challenges.
• Knowledge of and experience with safety and environmental compliance regulations.
• Excellent leadership and team-development skills.
• Excellent verbal and written communication skills.
• Ability to contribute actively to improvements in policies, practices, and procedures.
• Ability to interact and communicate effectively with customers and employees at all levels, including senior management.
• Leadership of QC Analysts and QC Laboratory Administrators
Why Join Croda?
The successful candidate will receive a competitive salary and benefits package including:
• Excellent Medical, Dental, and Vision coverage, available immediately.
• Generous PTO
• 401K Match
• Wellness Reimbursement
• Parental Leave
• Career Development
• Company paid and voluntary Life and AD&D Insurance
• Short and long term disability
• Paid Holidays