My client is growing and currently seeking to hire a Director, Quality Assurance. They will relocate the right candidate. Unfortunately, Visa sponsorship is NOT available for this role.
The Director, Quality Assurance will be a key member of our Leadership team with responsibility for establishing and administering all Quality functions related to cGXX (cGMP, QSR and cGTP) operations. The Director, Quality Assurance will provide quality oversight and support our manufacturing, processing, testing and product distribution functions. The position requires domestic and international travel, primarily to our locations to ensure compliance with domestic and international regulations.
Responsible for the design and implementation of policies and procedures to ensure that quality standards are met. Oversees testing of processes and products. Familiar with a variety of the field’s concepts, practices, and procedures. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. Leads and directs the work of others
Educational Requirements / Qualifications
- BA, MS or PhD with at least 10 years’ experience in a quality assurance or related role.
- Demonstrated knowledge of cGXXs and relevant regulatory guidelines, both in the US and OUS.
- Familiarity with ISO 13485 requirements for the design and manufacture of medical devices.
- Experience at all phases of development, including commercialization.
- Experience in leading external regulatory audits
- Demonstrate experience of successful hiring and management of a quality or related organization / group.
- Excellent oral and written communication skills
- Excellent interpersonal and team building skills
- Ability to work independently, analyze and work with attention to detail, process and prioritize sensitive complex information and problem solve
- Ability to exercise creativity and judgment
- Experience with human tissue products or implantable medical devices desirable
- Experience with quality functions for biologics desirable
- Experience with Six Sigma and/or Lean Manufacturing desirable
- Familiar with preparation of and guidelines for Chemistry, Manufacturing and Controls (Module 3) worldwide regulatory submissions desirable.
- The specific duties of the Director, Quality Assurance include but are not limited to:
- Establish and administer our Quality Management System
- Responsible for all quality functions related to human tissue products, biologic products and medical devices.
- Ensure compliance with relevant domestic and international quality requirements
- Provide guidance on and administer process validation activities
- Perform risk assessments, lead investigations to address quality issues
- Perform release and disposition functions; manage and control cGXX-manufactured intermediates and products; work with our Operations, Clinical and Translation Science staff as required
- Represent us during external audits and inspections and ensure pre-approval inspection readiness
- Participate in vendor selection, assessment and qualification
- Work with internal and external technical teams (process, analytical, formulation development, quality control)
- Recruit, develop, and manage the Quality Assurance department as the company’s pipeline and development activities grow
- Develop budget for Quality Assurance department
- Dynamic environment and each employee may be asked to assist in work areas outside of their usual duties. This is an expectation of every employee and it allows for future growth opportunities.
- As a key and senior member of our Leadership team, the Director is expected to participate in operational and strategic discussions that impact the entire organization.
- Other duties as assigned
If interested and more importantly qualified, send an updated copy of your resume to firstname.lastname@example.org with contact info and you will be contacted immediately. I will send a more detailed job description.
This position could pay a very competitive base salary plus bonus and an excellent comprehensive benefits package.
Unfortunately Visa sponsorship or Transfer NOT available for this role.