QA/QC Director

ProcessHQ, Inc.; California; On-site; USD 180,000 - 240,000; Full time

Job summary

ProcessHQ, Inc. seeks a QA/QC Director to oversee all quality assurance and quality control activities, ensuring cGMP compliance, regulatory alignment, and adherence to company standards. You will drive QMS, audits, CAPAs, investigations, and training.

The role requires a strong scientific background, 5+ years in regulated industries with 3–5 years in management, and a Bachelor's degree in a related field. Leadership is essential to mentor staff and meet KPI targets.

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.

Responsibilities

• Develop, implement, and maintain Quality Management Systems in compliance with ISO 9001-2015.
• 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.

Skills

Quality management systems

GMP compliance

Leadership & mentoring

Audits & regulatory inspections

CAPA management

Root cause analysis

Validation/qualification/stability

Data integrity

Regulatory expectations

Education

Bachelor's degree in a scientific discipline

Job description

Job Description

Job Description

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.