Lead, QA/QC

The Lead, QA/QC is responsible for providing quality oversight and guidance both internally and to external partners. The Lead, QA/QC performs quality functions including, but not limited to, oversight of quality systems (deviations; CAPAs; change control; document control; training); complaint/adverse event management; auditing (supplier management; internal auditing); product release and stability; and regulatory inspections and submissions support. The Lead, QA/QC participates as quality representative on project teams supporting internal projects and quality events, and products in development, undergoing technical transfer, or being considered for acquisition. Knowledge of quality systems as related to cGxP is required. Experience with biologics, devices, combination products and/or small molecules, multiple dosage forms and routes of administration desired. Seeking strong team contributor, outgoing, proactive and efficient. Cross-functional experience including technical background in analytical, quality control or process development is preferred.

DUTIES AND RESPONSIBILITIES:

The following reflects management's definition of essential functions for this job but does not restrict the tasks that may be assigned. Management may assign or reassign duties and responsibilities to this job at any time due to reasonable accommodation or other reasons.

• Responsible for maintaining and using quality systems, including but not limited to, change control, deviation management, corrective and preventive action (CAPA) programs, etc.
• Responsible for maintaining document management systems for creation, approval, maintenance, issuance, control, and storage of GxP documents.
• Assists in establishing and delivering training programs and continuing education programs in the areas of quality assurance with emphasis on ensuring that the employee base has a clear understanding of regulatory quality system processes and tools including GxP requirements. Assist other departments in defining training requirements and liaise to ensure successful implementation.
• Responsible for liaising with and providing quality oversight to contract manufacturing organizations (CMOs) and contract laboratory organizations (CLOs) including review of respective change controls, deviations, CAPAs, etc. with potential impact to product.
• Responsible for batch record review and batch disposition for clinical and commercial products. Provide quality oversight of USWM contractors to support the manufacturing, packaging, testing, release and distribution of clinical and commercial products to approved jurisdictions. Manage internal and third party investigation and deviation meetings and establish disposition metrics for USWM and third parties. Communicate product quality issues to management and provide information during Quality/Material Review board meetings when out of specification results, investigations, or other issues impact batch disposition or the status of marketed batches.
• Responsible for providing QA/QC guidance to and support for development, clinical, and technology transfer projects
• Responsible for stability program management for development, clinical, and commercial products and quality oversight of CLOs. Compile and review stability reports and perform stability data trending.
• Responsible for collecting key quality and compliance metrics for presentation at Management Review meetings or Quality/Business Review meetings with CMOs/CLOs. Responsible for action plans and follow ups to resolve issues.
• Support vendor management and qualification program activities which may include but is not limited to external auditing - scheduling; planning; auditing; reporting; and follow ups with vendor through CAPA closure. Responsible for maintaining and revising Quality/Technical Agreements and monitoring adherance to terms.
• Support the internal audit schedule, performing internal audits of other GXP departments, and ensuring follow ups are complete.
• Support regulatory inspections / being part of team that supports inspections, responds to findings, and completes/oversees follow up actions.
• Support Complaint/Adverse Event programs. Provide timely investigation resolution of complaints and adverse events. Provide support for field alerts, medical device reporting, and communication to required regulatory authorities, etc.
• Support the recall program and participating in annual mock recalls to ensure recall preparedness.
• Provide support to regulatory department including compilation of data for clinical or commercial products to support annual reports or submission updates.

QUALIFICATIONS

• Bachelor's Degree in Science or Engineering discipline
• Minimum 5 years work experience in the pharmaceutical, medical device or biologics industry
• Strong team contributor
• Experience with cGxP quality systems
• Cross-functional experience with technical background in analytical, quality control or process development is preferred
• Data analysis, trending and interpretation skills needed
• Experience with biologics, devices, combination products and/or small molecules, multiple dosage forms and routes of administration desired.

The physical demands and work environment described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

PHYSICAL DEMANDS

• Occasionally required to walk.
• Constantly required to sit.
• Occasionally required to lift light weights (less than 25 pounds)
• Specific vision abilities required for this job include: close vision, color vision, and ability to adjust or focus
• Occasional travel required including overnight stays, estimated 20%

WORK ENVIRONMENT

• The noise level in the work environment usually is moderate.

Equal opportunity employer, and does not discriminate on the basis of race, color, religion, sex, pregnancy, national origin, disability, age, genetic information, veteran status, sexual orientation, gender identity or any other characteristic protected by federal, state or local law.