QA/QC Director at Biotek Systems-ProcessHQ, Inc.

Benefits

• 401(k)
• Bonus based on performance
• Competitive salary
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

A Biopharmaceutical manufacturing solutions supplier is seeking a QA/QC Director to oversee all Quality Assurance and Quality Control activities ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company quality standards. This role leads quality systems, manufacturing operations, investigations, audits, validation activities, and continuous improvement initiatives to ensure the safety, efficacy, and quality of our bioprocess manufacturing offerings.

Key Responsibilities:

• Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 9001-2015.
• Manage and maintain ISO 9001 annual certification.
• Manage deviations, CAPAs, change controls, risk assessments, and product quality complaints.
• Ensure compliance with cGMP, GDP, and data integrity requirements.
• Lead internal audits and support customer audits.
• Oversee training programs related to quality systems and GMP compliance.
• Lead, mentor, and develop QC/QA personnel.
• Establish departmental goals, KPIs, and performance objectives.

Qualifications:

• 5+ years of experience in pharmaceutical, biotechnology, or related regulated industries.
• Minimum of 3–5 years of management experience in QA/QC, or Quality Operations.
• Experience with investigations, CAPA management, and root cause analysis.
• Familiarity with validation, qualification, and stability programs.
• Strong understanding of data integrity requirements and regulatory expectations.
• Bachelor's degree in a scientific discipline. Chemistry, Pharmaceutical Sciences, Biology, Microbiology, or a related scientific field required.