John R. Nocero

About John R. Nocero

I build and fix quality departments. I fixed the quality department at Health Decisions, built one at Matrix Clinical Trials, fixed one at ProQuest and am combining those talents at Flagship Biosciences building a young and hungry QD staff both in RTP and Colorado. I believe in myself and who I am. I walk it like I talk it, do what I say, when I say it, how I say it. Just like Becky is not a tagline. Becky Lynch inspires me. She is the face of her entire industry - THE GOAT Her personal story centers on achievement, tenacity, grit and overcoming adversity. She epitomizes being \"The Man\" in your own life. I was on TV with her on May 15, 2023.#greatestmomentofmylife. I am her. I don\'t level up. I don\'t man up. I Becky Up. RESULTS I energize and educate research professionals. I give simple, sustainable solutions to organizational quality, data and outcome challenges. I know clinical trials, complex projects, quality, compliance and professional development. HOW I MOTIVATE TEAMS My work style is direct and decisive. I carry a long-standing reputation for executing on time, every time. I’ve led cross-functional initiatives that have achieved local, national and international recognition. THERAPEUTIC SPECIALTIES Neurology, Digestive Disease, Pulmonary, Critical Care, Cardiovascular, Ophthalmology, Women\'s Health, Infectious Disease 44••••••05 OR J•••••@YAHOO.COM KEY STRENGTHS Clinical Research | Healthcare Management | Quality Assurance | Regulatory Compliance | GCP Audits | SOP Development | FDA & ICH GCP | SDLC | Risk Assessments | Database Management | Continuous Process Improvement | Corrective Action Planning | Budget Administration and Study Feasibility | Employee Engagement | Training & Development | Presentations

Experience

1. Director of Quality

   Flagship Biosciences, Inc

   Apr 2022 — Present · Morrisville, NC, US

   Recruited to lead five-person quality department in all aspects of quality, regulatory, education, training and compliance. Promoted in February 2023 to have oversight over all Quality Departments in Flagship\'s USA sites-Responsible for direct growth and QMS improvement leading new QMS migration-Recommend, create, implement and update QMS documents to improve processes and support compliance – 150+ policies and procedures reviewed and/or written to mitigate risk-Defined and implemented quality metrics for maintaining regulatory compliance for commercial operations for corrective actions, system validations and corporate goals-Develop company regulatory strategy focusing on internal audits and external inspections-Rebuilt quality staff; Trained and mentored to support organizational operations-Manages the team in preparation of regulatory agency inspections or third-party audits and responses to deficiency letters. Negotiates submission data requirements and deliverable dates with regulatory authorities and cross-functional teams-Serves as the directed resource for Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and College of American Pathologists (CAP) accreditation standards for all four laboratories-Accomplishments: Facilitated five audits (one for-cause), seven investigations; CAP/BAP Inspection with no major findings; defined new department structure focused on regulatory and education; revamped NCE/CAPA reporting process and CLIP metrics to report to senior leadership; lead and implemented new monitoring system computer validation. Developed Q-riccuulum education program creating competency metrics and educational standards for ~60 employees.

Education

• Capella University

  Doctor of Philosophy (PhD)

  2009 — 2012

• Hiram College

  Bachelor of Arts (B.A.)

• American InterContinental University

  Master of Business Administration (M.B.A.)

  2006 — 2009