Director of Quality

We have a Director of Quality position available in Irving, TX. This is a full-time, M-F, in office position.

Job Description

We have a Director of Quality position available in Irving, TX. This is a full-time, M-F, in office position.

Responsible for managing all Quality Assurance (QA), Quality Control (QC) and Quality Systems (QS) functions supporting all aspects of compounding pharmaceuticals and regulatory compliance within the facility. Operates the area as the supervisor over the QA, QC and QS staff, coordinating roles & responsibilities and projects. The position requires an experienced QA professional with expertise in Health Agencies regulations and guidelines on a pharmaceutical Quality Management System in all aspects including Materials, Personnel, Production, Laboratory, Facilities, and Documentation Controls.

• Supervises QA, QC & QS personnel by providing learning and development where appropriate.
• Ability to make Quality decisions related to maintenance of aseptic conditions within clean rooms with a focus on Sterility Assurance during manufacturing operations.
• Responsible for on-time clinical batch disposition. Ensure review of batch data, including batch records, deviations, and other quality systems as applicable to determine acceptability of product disposition.
• Manages the on-time initiation and closure of Deviations / Investigations, CAPAs, Change Controls with thorough & standardized supporting documentation. Mentor investigators and approvers on the investigation process and technical writing.
• Ensures quality staff performs and approves root cause analysis and product impact assessments for investigations resulting from deviations and OOS.
• Manages others to ensure appropriate SOPs and training documents are in place & effective.
• Manages others to ensure timely qualification and re-qualification of suppliers to include scheduling of audits.
• Negotiates, monitors and maintains Quality Agreements with Contract Labs, Vendors, and Service Suppliers, where applicable
• Manages others to ensure the design and maintenance of the environmental monitoring program including environmental and personnel monitoring are adequate and in place.
• Maintain compliance with FDA and cGMP guidelines, state, and federal laws.
• Prepares and submits weekly/monthly reports, prepares metrics and trends data to identify and prioritize continuous improvement opportunities.
• Manages others to maintain site documents supporting the manufacturing & release of sterile and non-sterile products.
• Manages the design and implementation of site policies and procedures.
• Escalates to Executive Management team critical issues jeopardizing manufacturing & release of a safe & effective product that meets regulatory requirements.
• Promptly communicates with Operations regarding complaints, product issues/variances.
• Enforces applicable personnel policies and procedures.
• Serve as the Quality lead to support product Risk Assessments, supporting the identification of Quality risks and appropriate mitigation plans to achieve compliant solutions.
• Present and defend the Quality Management System (QMS) in regulatory inspections.
• QA oversight of equipment/facility/process validation and re-qualification program and validation master plan.
• Review protocols, data summaries, reports for stability studies.

• Legally authorized to work in the US.
• Bachelor's Degree is required:
  Technical (Chemistry, Biology, Microbiology, or Engineering) or other related field; advance degree preferred.
• Minimum 10 years prior experience in Quality Assurance / cGMP / FDA regulated industry.
• Minimum 5 years of supervisory or management experience required.
• Strong knowledge of FDA, ICH regulations and guidelines on QMS.
• Experience with aseptic techniques and appropriate gowning techniques supporting manufacturing of sterile injectable products.
• Technical writing and communication.
• Well versed in the compliance & quality requirements of pharmaceutical industry and cGMPs and have demonstrated strength in problem solving and resolution.
• Experience with implementation of electronic Document, Training, and Exception Management systems
• Strong ability to multi-task and adjust priorities in a dynamic environment
• Strong interpersonal skills.

We specialize in compounding office-use and personalized prescription medications.