Director, QA
- Employer
- Frederick National Laboratory for Cancer Research
- Location
- Frederick, MD, USA
- Start date
- Mar 18, 2019
View more
- Discipline
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioCapital
Job Details
KEY ROLES/RESPONSIBILITIES
Reporting to the Chief Medical Officer, the QA Director's role will encompass all aspects of quality assurance, from strategic planning to hands-on implementation.
The QA Director will:
- Manage a group of at least 35 employees reporting into 8 quality assurance functions
- Be responsible for the strategy, implementation and leadership of the QA and Regulatory function
- Be accountable for the execution and administration of the GxP quality system pertaining to GMP and relevant ICH, US, and EU regulations
- Ensure overall quality and compliance oversight for manufacturing, clinical and supply chain activities
- Establish and maintain a phase-appropriate quality management system
- Ensure appropriate quality oversight of external vendors, e.g., contact manufacturing organization (CMO), contract testing labs (CTL)
- Plan and oversee day-to-day activities of the quality function including management of consultants, external auditors, internal quality functions, e.g., continuous improvement, training, compliance, document control, lot release, regulatory affairs, validation/calibration, and computer systems validation
- Lead preparations and management of regulatory inspections and client audits
- Provide leadership and mentorship of the quality team
BASIC QUALIFICATIONS
- Possession of a BA/BS degree in a related field from an accredited college or university according to the Council for Higher Education Accreditation (CHEA). (Additional qualifying experience may be substituted for the required education). Foreign degrees must be evaluated for U.S. equivalency.
- In addition to the education requirements, a minimum of twelve (12) years of experience in Quality Assurance including at least eight (8) years of management experience
- Extensive knowledge and experience in GxP and QA principles, practices, regulatory and industry standards
- Experience with using risk-based principles and decision making to ensure compliance at all stages of development
- Strong negotiation skills
- Must be able to obtain and maintain a clearance
PREFERRED QUALIFICATIONS
- Master's degree in science or regulatory affairs
- Experience working in a small biopharmaceutical company producing Phase I/II clinical materials, including vaccines and biotherapeutics
- Experience with parenterals
- Regulatory Affairs Certification (RAC)
- A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
- Proven track record of leadership and building relationships with both internal and external customers
- Flexibility and ability to provide a solution-based approach to emerging challenges
Company
A rewarding career with global impact
Whether you’re an expert in your field or just starting out, we have a career opportunity for you. We’re always looking for people to join us in fulfilling the mission of the Frederick National Laboratory: discovery, innovation, and success in the biomedical sciences.
Our team of 2,400+ scientists, technicians, administrators, and support staff work at the forefront of basic, translational, and preclinical science, with a focus on cancer, AIDS, and other infectious diseases.
We collaborate with colleagues across the National Cancer Institute, National Institutes of Allergy and Infectious Diseases, and others throughout the National Institutes of Health. We also engage with extramural investigators in academia, government and industry.
Your path to joining our team begins with the desire to work for the only national laboratory dedicated to biomedical research. Our employees share a common desire to help make a difference in cancer research and public health concerns. As you search for a career that fits your education, skills, and abilities, explore the core values that guide us and emphasize work-life balance.
Discover why joining the Frederick National Laboratory team could be the most important career step you take
- Website
- https://frederick.cancer.gov/
- Phone
- 301-846-1000
- Location
-
8560 Progress Drive
Frederick
MD
21701
US
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