QA/QC Director

Biotek Systems-ProcessHQ, Inc.; Glendale (CA); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

401(k)

Bonus based on performance

Competitive salary

Dental insurance

Health insurance

Paid time off

Vision insurance

Job summary

Biotek Systems-ProcessHQ, Inc. is seeking a QA/QC Director to oversee all QA/QC activities ensuring cGMP compliance, regulatory alignment, and company quality standards. The role leads quality systems, investigations, audits, validation, and continuous improvement across bioprocess manufacturing offerings.

The successful candidate will manage deviations, CAPAs, and training while mentoring QC/QA personnel and establishing clear KPIs for performance and improvement.

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.

Responsibilities

• Develop, implement, and maintain QMS in compliance with ISO 9001-2015.
• Manage and maintain ISO 9001 annual certification.
• Oversee 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.

Skills

QA/QC management

Investigations

CAPA management

Root cause analysis

Data integrity

Education

Bachelor's degree in a scientific discipline

Job description

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.