| Director, Quality and Regulatory Affairs Versiti - Grand Rapids, Michigan Versiti was founded with the belief that together, our blood centers can better serve patients’ urgent need for life-saving healthcare. We love what we do, and we’re looking for passionate individuals to join the Versiti family. We foster a diverse environment that affirms each employee’s dignity and worth, and we offer a chance to work with a team of compassionate people who provide lifesaving blood to our communities on a daily basis. Under the direction of the Chief Quality Officer provides leadership and direction for developing, implementing, and executing quality assurance processes and practices that support the manufacture of FDA-regulated biologics (blood and tissue). The primary responsibility is to lead the affiliate QA/RA/QMS function for these services and ensure that all activities meet regulatory requirements and result in high quality, safe, and effective products and services. Supports standardization of policies, processes, procedures, and practices across Versiti. Promotes culture of quality and compliance. Works effectively with other Quality Directors within Versiti to provide effective quality and compliance solutions and practices that advance Versiti Quality mission. Requirements: - Bachelor ‘s degree in a scientific field from an accredited university.
- Academic training or direct work experience in Master’s degree in a scientific field, business, health care or other related field preferred.
- Previous experience working in a blood bank required.
- Minimum five years’ experience in a regulated industry (biologics, pharma, or medical device), where change management, validation, and creation of SOPs (standard operating procedures) has been required and successfully implemented.
- A minimum of 3 years of direct management experience or progressively more responsible project management experience is required.
- Prior experience participating and/or managing FDA inspections is required. Additional experience working with accreditation bodies and third-party auditors preferred.
You can find the job posting and apply: https://bcw.taleo.net/careersection/ex/jobdetail.ftl?job=1900006M&lang=en&sns_id=mailto#.Xcw3DhveFZc.mailto If you have further questions, please reach out to me: Melissa Manley, mmanley@versiti.org |
