Open Positions

 Director, Quality 12-WMC-07

Job Description: Quality Operations for pharmaceutical and in vitro diagnostics products require a leader to ensure that GMP, GLP, GCP requirements and applicable laws are followed during the development and commercialization of such products.

Job Duties/Responsibilities: The Director of Quality is responsible for:
  • Managing 5 independent quality systems with a global perspective to be in compliance with USA and European regulations.
  • Overseeing the Quality System for Wellstat Diagnostics in compliance with CFR 820 and ISO 9000/13485.
  • Leading Quality Assurance, Quality Control, Compliance, Validation, Metrology, Supply Chain, Regulatory (CMC), Document Control and Clinical Quality Assurance departments.
  • Managing investigations, deviations, change control, corrective and preventive actions (CAPA), out of specification (OOS), out of tolerance (OOT), employee training and non conformance.
  • Point of Contact and Coordination of Contract Manufacturing and Contract Testing (GMP).
  • Scheduling manufacturing and releasing products for clinical and commercial supply. Person in Plant for critical operations.
  • Participating in business development activities related to presentations/negotiations with possible partners for all the companies.
  • Leading CMC regulatory efforts.
  • Managing Supplier Qualification Program for the Wellstat Group of Companies, including site auditing, vendor selection, pricing, services and quality agreements.
  • Generation, approval and implementation of Commercial Supply, Quality and Technical Agreements with CMOs.
  • Evaluating facilities for GMP operations.

Qualifications: (experience, education, software or equipment): BS/MS or PhD in a scientific discipline, along with at least 15 years of relevant experience. Candidate must have experience in small molecules, diagnostics and biologics. Excellent communication and presentation skills are required. Proven contract management skills are a must. Willing to travel 25% to 50% of time.

Wellstat Management Company is an equal opportunity employer and offers a competitive salary and comprehensive benefits package. Please send CV and salary requirements to: Wellstat Management Company, 930 Clopper Road, Gaithersburg, MD 20878, Attn: HR/CW, or Fax to 301/869-8721 or apply online at [email protected].. Wellstat Management is an equal opportunity employer.