Director, QA

Location
Frederick, MD, USA
Posted
Dec 20, 2018
Ref
req209
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
The Vaccine Clinical Materials Program (VCMP) is responsible for the overall direction of the operations/manufacturing of the vaccine and biotherapeutic development facility for the development of experimental therapeutics for pre-clinical and Phase I/II clinical trials targeting a range of infectious diseases.

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
Equal Opportunity Employer (EOE) | Minority/Female/Disabled/Veteran (M/F/D/V) | Drug Free Workplace (DFW)