This Jobot Job is hosted by: Mary Lazarine Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $75,000 - $95,000 per year
A bit about us:
CDMO specializing in cell & gene therapies production. Our goal is to establish global manufacturing solution, ensuring the product development and manufacturing of robust process and expediting your pathway to successful approval.
Why join us?
To provide our clients with world-class innovative manufacturing solutions designed to accelerate the delivery of advanced cell and gene therapies from idea to patient.
401(k) Dental insurance Health insurance Vision insurance
Job Details
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
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 client 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
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