Director, Quality Control Lab (Chantilly, VA)

As a Director, Quality Control (Chantilly, VA) at Granules Pharmaceuticals Inc, you will be responsible for directing and managing all facets of the Quality Control Lab, including samples, reference standards, supply/equipment, QC data trending analysis in compliance with cGMP/ICH and pharmaceutical regulatory compliance.

Responsibilities include:

• Represent QC department during scientific and technical discussions with clients, vendors, and FDA representatives;
• Build and implement effective laboratory systems, processes, and teams for smooth lab operation using QC Validations;
• Oversee Quality Control Laboratory to ensure accurate analytical chemical testing results, adherence to company protocols, and timely completion of projects using HPLC-UV, GC, IQ/OQ/PQ, STPs;
• Interface with different departments regarding quality issues, audits, and special projects;
• Provide guidance to pharmaceutical manufacturing regarding quality and cGMP issues to ensure compliance with regulatory standards;
• Review and approve OOS/OOT, SOPs, lab related investigations, stability failure notifications, COAs, and compilation of stability-related data;
• Review and approve STMs for raw materials, packaging materials, and in-process and finished products;
• Review and authorize certificates of analysis and purchase requisitions;
• Supervise 4 QC Managers.

Requirements:

• Must have a Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Science, or Physical Chemistry plus 5 years experience in job offered.
• Require skills and knowledge in QC Validations, OOT, cGMP/ICH, STPs, SOPs, HPLC-UV, GC, IQ/OQ/PQ.

Job location: Chantilly, VA. Submit résumé referencing job code SEE001 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.