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.
About
ProcessHQ Mission
ProcessHQ, Inc. was established in 1999 as a Delaware corporation, to address the need for a vertically integrated bioprocess manufacturing solutions provider to serve the burgeoning West Coast biotech market. From its inception, the company has focused exclusively on its target market to provide clients with a comprehensive, focused solution that leverages the founders' thorough understanding of the biotechnology industry, its technology, and its specific needs.
Our specialty is bringing innovative and cost efficient solutions to market to solve challenging process problems. Working closely with a strong lineup of industry partners, we strive to meet and exceed our clients' expectations for quality, service, and cost.
The ProcessHQ.com online procurement site was developed to provide a solution to the high cost and inefficiency of the traditional sanitary process equipment purchasing process. ProcessHQ.com enables process manufacturing professionals to evaluate equipment, obtain component specifications, and place orders, all without leaving their desks. Our comprehensive online catalog allows end users and purchasing agents to select from a full line of specialized components, materials and equipment necessary for sanitary process manufacturing.