Quality Assurance Manager

Job Code:

Q1072

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JOB DESCRIPTION

The Quality Assurance (QA) Manager is responsible for the day to day management of the Quality Assurance team and is responsible for hiring, managing performance, and development of Quality Assurance staff at Matica Biotechnology in College Station, Texas.

The individual Is recognized as a subject matter expert regarding Quality Assurance practices and procedures, and serves as the main point-of-contact for all QA activities. The QA Manager is responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, and strategy objectives of the company and the department. The individual initiates and oversees projects aimed at cost reduction, efficiency improvements, minimization of downtime and quality and safety enhancement. The QA Manager makes recommendations regarding departmental capital planning, budget and standards development. The individual must be able to identify and communicate improvement opportunities and results. The QA Manager identifies operational needs for projects, ensuring site/divisional linkage is achieved. The individual must be able to identify and address short term, intermediate, and long-term issues, and be able to appropriately resolve conflict and prioritize work as necessary. The individual must hold a certification in Quality Audits for both internal and external audits.

RESPONSIBILITIES

  • Provide the strategic leadership and management for the Quality Assurance team

  • Function as a management role within the QA department and must demonstrate excellent leadership, communication, critical thinking, and organizational skills

  • Oversee the activities of multiple direct reports and determination of growth opportunities

  • Implement continuous improvement initiatives to drive Quality Assurance programs and ensure maximum productivity.  Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.

  • Develop, implement and monitor Quality programs, policies and procedures to ensure compliance with GMP standards, corporate policies, FDA, EMA and other regulatory body regulations and guidelines.

  • Manage the electronic Quality Management System and processes and recommend and implement any additional systems to ensure the achievement of long-term objectives.

  • Review and approval of facility validation protocols, data, and reports

  • Establish and maintain a positive working relationship with customers, the FDA and other regulatory authorities. Represent Matica Bio on Quality, Regulatory Affairs, and cGMP compliance issues.

  • Perform other duties as assigned. 

QUALIFICATIONS

  • BS/BA in a life science, preferably in biology, biochemistry, microbiology, biotechnology, pharmaceutical sciences, or related technical field.

  • 10+ years related GMP experience in biotechnology, pharmaceutical, manufacturing or laboratory environment.

  • Certified Quality Auditor is required