Within regulated sectors such as Biotech, Medical Devices, and Pharmaceuticals, establishing a robust Quality Management System (QMS) is of utmost importance. My proficiency lies in identifying and addressing deficiencies in Quality Systems, tailoring them meticulously to meet distinct business demands. I specialize in providing temporary Quality Support for enterprises facing challenges like Warning Letters and Consent Decrees. In this role, I mentor teams in vital departments like Quality Assurance, Quality Control, and Manufacturing, steering them towards compliance with both federal and international regulations. Additionally, I excel in implementing fresh Quality Management Systems, aiding startups and established companies alike in meeting evolving regulatory standards.My support spans diverse key areas:• Audits• Complaint Handling/Investigations• Consent Decree/Warning Letter Remediation• Corrective/Preventive Actions (CAPA)• Data Integrity• Design Control • Deviations• Environmental Investigations • Inspection Readiness• Gap Assessments• Out of Specifications (OOS)• Quality Metrics • Risk Management • SOP Writing• TrainingIn summary, my diverse expertise and leadership have significantly impacted various companies in the regulated industries, ensuring their Quality Management Systems align seamlessly with their business needs and comply with stringent regulations.

I have had the privilege of sharing my expertise and insights as a professional speaker at various prestigious platforms. I have spoken at ASQ Section meetings, engaging with industry professionals and enthusiasts, where I delved into the nuances of complaint handling, a topic crucial in the realm of quality management. Additionally, I have had the honor of addressing diverse audiences at conferences like Kenx, where I discussed effective strategies for complaint management, drawing from my extensive experience in regulated industries. As a guest speaker at Marquette University's 707 HUB, I had the opportunity to inspire and educate budding talents, imparting knowledge on the intricate processes of quality management and the importance of risk management in sectors such as Biotech, Medical Devices, and Pharmaceuticals. These experiences have not only allowed me to share my knowledge but also to learn from the engaging interactions with diverse audiences, further enriching my understanding of the field.

In my role as an Adjunct Professor for Temple University College of Pharmacy, facilitated through Kenx, I have had the opportunity to contribute significantly to the education and professional development of aspiring and current pharmaceutical and medical device professionals. My focus has primarily been on quality management systems, with a specialization in complaint handling and investigations, crucial aspects in the pharmaceutical and medical device industries. I have not only imparted knowledge but also actively contributed to the development of effective learning environments. Moreover, I have played a pivotal role in shaping the industry itself. I have been involved in the creation of comprehensive training systems and programs tailored specifically for pharmaceutical and medical device companies. These initiatives have been designed to enhance the skills and expertise of professionals within these sectors, ensuring that they are well-equipped to navigate the complexities of quality management, complaint handling, and investigations. My dual role as an educator and a creator of training systems reflects my commitment to advancing the standards of excellence in these industries.

Provided tactical planning and resources for registrations and overall Quality Management System including all QA projects and daily QA activities. Conducted audits on current and new critical suppliers. Participated in corporate audits and regulatory inspections (e.g., FDA, notified body) as the management representative. Implemented and managed a new effective CAPA system. Managed complaint handling processes which assisted in reducing lead time in complaint closure. Managed a remediation project to obtain ISO 13485 recertification for the division.

Worked for Wyeth which was bought by Pfizer in 2008.Managed team of up to 20 employees who reviewed and approved method validations, antibody/standard qualifications, method/tech transfers, analytical instrument qualifications, equipment qualifications, utility validations, computer system validations and laboratory maintenance documentation. Provided tactical planning and resources to all laboratory validation projects. Utilized TRACKWISE® to review Manufacturing Investigation Reports (MIRs), Laboratory Investigation Reports (LIRs) and Corrective Actions/Preventive Actions (CAPA). Developed entry-level staff members into solid performers through actively coaching, developing and transferring job knowledge and skills to employees. Reduced non-value added staff activities by 30% through utilization of metrics resulting in increased productivity. Sponsored Lean Six Sigma Green Belt, which streamlined analytical instrument qualification process. Performed Risk Management activities for Raw Material Qualifications and Supplier Qualifications as project manager which reduced number of audits required per year. Participated in corporate audits and regulatory inspections (e.g., FDA, EMEA) as a QA Reviewer. Provided support as primary QA liaison for a consent decree laboratory capital project, which included qualification of analytical instruments, equipment, utilities and computer systems for a new laboratory building.

Provided compliance support for Development Quality Control organization. Provided support to Change Control Committee as laboratory Change Control Committee member. Prepared audit and regulatory inspection (e.g. FDA, EMEA) responses for corporate audits and regulatory inspections. Tracked audit and inspection commitments to meet timelines. Wrote, edited and approved standard operating procedures (SOPs) for various departments. Developed and implemented new quality systems to comply with new regulatory requirements in response to consent decree requirement. Developed and maintained skills training program for department’s scientific staff. Developed and maintained analytical instrument qualification and its elements such as Periodic Reviews and Change Management. Reduced non-value added staff activities by 15% through utilization of metrics resulting in increased productivity.

Collaborated with electrochemists from iSTAT in Ottawa, Ontario to develop new medical device that included supervision development studies conducted at iSTAT. Maintained controlled current Good Manufacturing Practice (cGMP) documents by maintaining files. Audited laboratory in compliance with Good Laboratory Practices (GLP) regulations. Lead Investigator on troubleshooting teams that investigated manufacturing and testing failures to determine root causes and corrective/preventive actions. Developed and manufactured biochemical components including rare reagents during development stage. Performed process improvements on existing assays to gain efficiencies.

Wrote and edited SOPs and batch records in response to a consent decree requirement. Developed and implemented plan to reduce errors in documentation by auditing production lines and assessing root cause. Trained other staff members in document control, which resulted in additional assistance in writing SOPs. Manufactured assay kits under cGMP. Performed Quality Control testing on assay kits and rare reagents. Performed process improvements to gain efficiencies in manufacturing process. Investigated internal failures to determine root causes and corrective/preventive actions. Compiled and trended data for several projects including antibody purification study. Audited laboratories in compliance with cGMP regulations.