QC Manager, Critical Reagents

QC Manager of Critical Reagents - Permanent - Germantown MD

Proclinical is seeking a Quality Control Manager of Critical Reagents to lead a dedicated team.

Primary Responsibilities:

The successful candidate will be required to oversee reference standards and critical reagents in line with internal SOPs and ICH guidelines. This role requires strong leadership, statistical and technical knowledge, and a commitment to quality and compliance.

Skills & Requirements:

• Bachelor's degree in Life Sciences or 10 or more years of relevant experience and at least 5 years of management experience within a GMP regulated lab is a necessity.
• Expertise in Reference Standards Program, including ICH regulations and quality control methods.
• Strong background in biostatistics for evaluating comparability and qualification of new reference standards.
• Experience in Quality Assurance/QC within the biologic, pharmaceutical, or medical device industry.
• Proficiency in writing SOPs, qualification protocols, and reports.
• Familiarity with LIMS, Qumas (or similar), and statistical software (.JMP).
• Broad experience with biochemistry, biological, and microbiological assay support.

The QC Manager's responsibilities will be:

• Oversee the Critical Reagents and Reference Standards function.
• Provide operational oversight for critical reagent management across the organization.
• Develop robust systems for the selection, qualification, monitoring, tracking, and storage of critical reagents.
• Build, develop, and coach a team to ensure the continued supply of critical reagents and reference standards.
• Establish new strategic capabilities for global inventory management systems.
• Act as the primary point of contact for the monitoring, tracking, and storage of critical reagents.
• Develop and implement policies, procedures, and training programs for regulatory compliance.
• Support regulatory submissions, inspections, and audits.
• Collaborate with cross-functional teams to develop risk assessments and mitigation strategies.
• Manage inventory, strategic planning, and lifecycle management of reference standards and critical materials.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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