QC Manager (EM)

We are partnered with an outstanding, long time client of ours who are looking to bring on a QC Manager (Environemtal Monitoring) to their team located in North Carolina! This position comes with an extremely competitive salary, benefits and more. The location is right outside of the direct RTP area.

Primary Responsibilities:

• Oversee all aspects of a Quality Control business unit, including quality systems, documentation, laboratory operations, compliance, budget management, and employee relations.
• Ensure adherence to cGMP standards and department safety protocols.
• Provide guidance and consult with manufacturing and regulatory teams on GXP-related matters.
• Utilize expertise and sound judgment to make independent decisions within defined areas of responsibility.
• Plan, analyze, delegate, and prioritize workflow to ensure timely completion of assignments and projects within budget constraints.
• Participate in regulatory and internal inspections/audits, including drafting written responses as required.
• Investigate and initiate corrective action plans for quality-related issues as necessary.
• Uphold high standards of integrity and professional values.

Key Responsibilities:

• Manage all aspects of the Quality Control Environmental Assurance unit, including environmental monitoring of facilities, utility systems, and fill lines.
• Author and/or approve department SOPs, conduct investigations, write reports, implement and approve process changes via the change control system, and lead continuous improvement initiatives to enhance environmental monitoring methods and processes.
• Serve as the system administrator for Environmental Assurance laboratory control systems, such as SAP, to ensure availability of environmental monitoring test data for site personnel and timely reporting for production-related decisions.
• Act as a subject matter expert on environmental monitoring issues, collaborating with production and quality assurance teams on projects, incident investigations, and annual product reviews.
• Participate in direct interactions with regulatory bodies and internal audits, including presenting site environmental monitoring data, responding to inquiries, and providing written responses as required.

Requirements:

• PhD in Life Sciences or a relevant field with at least 6 years of relevant experience, OR Master’s degree in Life Sciences or a relevant field with at least 8 years of relevant experience, OR Bachelor’s degree in Life Sciences or a relevant field with at least 10 years of relevant experience.
• Experience engaging with regulatory agencies regarding license submissions, inspections, and audit follow-ups.
• Preferred experience in aseptic/sterile filling operations.
• Equivalent combinations of education and experience may be considered, such as: