Associate Director of QC / HPLC

Position Responsibilities

• Serve as an HPLC subject matter expert and drive improvement of HPLC workflows and our Empower based CDS.
• Lead, coach, and develop a team of analysts and junior managers to ensure high technical and performance standards.
• Establish and maintain compliant laboratory operations aligned with Bionova quality standards and regulatory requirements, including the definition and monitoring of key performance indicators.
• Implement Lean laboratory practices and drive continuous improvement to enhance efficiency and performance.
• Review and interpret analytical data to identify trends, assess risk, and initiate appropriate corrective actions.
• Lead investigations for deviations, including OOS, OOT, OOR, and OOE, performing root cause analysis and defining corrective and preventive actions.
• Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein.
• Support cross-functional QC activities by providing cross-trained resources to address urgent analytical needs.
• Act as a subject matter expert during client audits and regulatory inspections, representing QC analytical and operational processes.

Qualifications

• Bachelor of Science degree or equivalent in a scientific field.
• Minimum of 6 years of experience in analytical or quality control environments.
• Minimum of 3 years of GMP Quality Control Laboratory.
• Strong working knowledge of HPLC and CE analytics with expertise in method development and GMP validation.
• Experience in designing CDS workflows (data review, audit trails, design of workflows, custom fields…).
• Expertise in data analysis, trend analysis, and statistical methods.
• Excellent written and verbal communication skills to effectively document findings and present technical information.
• Working knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex etc.).
• Demonstrated ability to deal with frequent changes, delays, or unexpected events.
• Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, or equivalent systems).
• Effective interpersonal and communication skills. Communication at all management levels and all staff is required.

Company Information

Company: Bionova Scientific LLC
Job Description: Associate Director of QC / HPLC