SUMMARY:

Quality and regulatory professional with progressive experience encompassing process and test method validation, facility & equipment qualification, quality assurance, auditing, and management; a motivated team player with self - direction, sense of urgency, composure, and excellent interpersonal skills; comprehensive understanding of quality systems & regulations for medical devices, biologics, pharma and combination products; extensive technical knowledge within GLP and GMP environments, including international standards; global experience with sound business and technical reasoning ability; Recognized for team leadership and collaboration that contribute to improved processes and regulatory compliance.

CAREER HISTORY AND EXPERIENCE:

Confidential, Mount Prospect, IL

Senior Project Engineer - Quality Assurance

Responsibilities:

• Responsible for establishing and managing supplier quality & receiving inspection programs in compliance with 21 CFR 820 requirements for a medical device company.
• Working cross-functionally ensuring accurate, timely, and regulation-compliant task management and establishing strategies in driving world-class supplier management processes.
• Hiring, training and managing support staff and interfacing with regulators. Achieved regulatory compliance for supplier management program.
• Performed a baseline study of the existing processes, identified gaps and implemented solutions.
• This helped the organization to upgrade their quality system to comply with FDA regulations and close out audit observations pertinent to purchasing controls and receiving inspection.
• Critically involved in issue resolution and decision making with suppliers and internal clients (such as Manufacturing, Engineering, Purchasing, Planning & Regulatory) by aligning expectations and bridging gaps in the processes.
• This helped to resolve issues with purchased products in a timely manner and reduced rejection rates in IQC by >50%.
• Ensured audit readiness and interfaced with regulatory auditors such as FDA and European Certifying body.
• Resulted in no audit observation for my area of responsibility.
• Managed supplier audit program and led key supplier audits within the US & International locations.
• Created audit tools, negotiated QTA and established supplier management process. Drafted SOPs and work instructions to formalize new processes and requirements.
• This helped to improve compliance to regulations, consistency and speed.
• Created reports for QMR, MRB and CAPA review meetings and facilitated decision making on product disposition and issue resolution. Presented program updates to Senior Management.
• Led QC inspection team in performing receiving inspection of purchased materials. Provided training to key supplier personnel in bringing them up to speed with Rauland requirements.
• Managed space allocation by coordinating with facility management for establishing an IQC lab. Identified and purchased vital Inspection equipment. Negotiated contract for ongoing calibration/service.
• Facilitated first article, in-process and receiving inspections resulting in the reduction of product quality issues down the line. Formed AQLs and sampling plans for purchased materials. Performed capability analysis, to evaluate supplier manufacturing processes. This helped suppliers to proactively adjust their processes before an out of spec situation results.

Confidential, Lake Forest, IL

Supplier Contract/Project Manager

Responsibilities:

• A leading manufacturer of generic injectable drugs, IV nutritional solutions, generic biotech drugs as well as related drug delivery systems such as prefilled syringes; electronic drug pumps and related medication management software.
• Responsible for managing supplier QA program at varying capacities.
• Ensured compliance to pharma, biological and medical device standards.
• Contract Manager with broader responsibility and commitments. Successfully managed 500+ audits, Third party auditors and support staff. Experience in leading audit teams and training auditors.
• Consolidated third party service providers and identified a more effective process that saved $200K for the department. Played a key role in relationship management with vendors. Negotiated contracts with service providers. Ensured Confidential requirements are met.
• Provided oversight to outsourced audits for about ten Confidential sites. Assisted with regulatory audit of multiple Confidential sites.
• Managed an audit budget of approximately $1 Million in 2013 and 2014. Worked with the Sr. Director and the Director of finance in planning and negotiating 2014 audit budget.
• Performed key supplier audits and ensured CAPA plans are adequate and effective.
• Played a key role by working directly with the Sr. Director of corporate audits in transitioning supplier auditing department to the corporate audit group.
• Requisitioned, hired, trained and managed four contract Quality Engineers to support outsourced audit program.
• Provided leadership and training to support staff and third party to ensure audits are performed and reports are written to meet Confidential ’s quality expectations and regulatory commitments. Developed an audit process WebEx to train global supplier personnel by working with the training department.
• Created tools to improve outsourced audit consistency and enhanced control through quality agreement. Established KPIs for Quality Engineers and third-party auditors. This resulted in improved compliance and efficiency. Presented monthly reports to management.
• Demonstrated high performance in planning, executing and managing the outsourced audit program in achieving goals while juggling multiple competing priorities and changes in business need.
• Conducted conference communications and presentations with clients and stakeholders regarding updates on projects and in training third party global auditors on Confidential ’s procedural requirements.
• Played a key role in hiring Supplier Auditors and support staff. Managed space allocation by coordinating with the building manager and HR and on boarding of new employees.
• Successfully organized and managed a week- long team building event for a team of 25 people from the Global compliance management and auditing team. This was a project outside the scope of my roles and responsibilities.

Quality Project Manager

Confidential

Responsibilities:

• Liaised with Confidential manufacturing sites (CMO) and customers in resolving manufacturing related issues. Traveled to Confidential manufacturing sites to participate in customer/ project review meetings. and customer due diligence audits.
• Reviewed and approved changes to products and processes that affect pharceutical products and assisted with method transfer projects.
• Maintained relationships with cross functional leads and worked effectively with cross functional teams in resolving issues and timely accomplishment of customer requirements.
• Established QTAs with key vendors.
• Redacted and appropriately communicated regulatory audit outcomes to pertinent customers.

Quality Engineer

Confidential

Responsibilities:

• Critically involved in reviewing and approving supplier audit reports created by third party auditors for medical devices and pharmaceutical/biologic drug products per federal and international regulations/standards and Confidential requirements.
• Performed supplier audits. Drafted reports.
• Tracked, reviewed and approved SCARs.
• Compiled and updated information using Trackwise and SharePoint.
• Coordinated and compiled pivotal information between Confidential sites and procurement for supplier audits. Led pre-and post-audit meetings with clients. This resulted in focused and effective on-site audits.
• Collaborated with cross functional teams to resolve issues and update project status. Initiated and follow through completion of change requests for SOPs and audit responses.
• Led remediation projects resulting from gap analysis as well as regulatory observation by coordinating with global sites. Proactively planned and worked with team members to ensure timely accomplishment of goals.

Confidential, Confidential Park, Illinois

Senior Quality Assurance Professional (Validation Q.A.)

Responsibilities:

• Identified elements of performance qualification and pre-requisites for ISO 5 (class 100) and ISO 8 (class100,000) manufacturing facilities, processes, test methods and equipment.
• Assessed the impact of product/process changes on the manufacturability of in-vitro diagnostics products and assay systems for the detection of antibodies or antigens to retroviruses.
• Ensured compliance to medical device regulations and biological products standards including CBER & CDER requirements.
• Critically involved in reviewing and approving hundreds of product and process change requests and validation deliverables.
• Provided quality assurance consulting in a cross functional environment for changes pertinent to manufacturing processes, products, validations and method transfers.
• Assisted with regulatory submissions by compiling validation records and ensuring compliance.
• Designed a computer based training (CBT) by establishing instructional design including learning objectives and all the exercises in conjunction with the Training department.
• Identified validation gaps and summarized findings to management with recommendations, which resulted in the creation of 2 process improvement projects and updates to SOPs. Managed these projects through completion. This helped my department in reducing cycle time for Q.A. review and increased speed and efficiency.
• Chaired monthly validation forums: Identified speakers, solicited topics, compiled presentation materials. Drafted and published meeting minutes.

Project Leader

Confidential

Responsibilities:

• Managed approval of nearly 10,000 change requests in 8 months per pre- established plan and timeline set by FDA and senior management for product certifications. In this role I coordinated with more than 70 individuals in following through and resolving on issues and achieving mile stones.

Validation Scientist

Confidential

Responsibilities:

• Assisted in drafting validation protocols and reports. Performed pre-validation studies.
• Accepted the role of an assistant statistician to meet an unforeseen budgetary challenge within the department.
• Assisted Sr. Statistician in performing data analysis and specification settings for test method validations.
• Successfully met all expectations.