Nick Piccoli

Nick Piccoli Email and Phone Number

Senior Director, Clinical Quality Assurance at Beacon Therapeutics @ Beacon Therapeutics
Nick Piccoli's Location
Wayne, Pennsylvania, United States, United States
Nick Piccoli's Contact Details
About Nick Piccoli

Nick Piccoli is a Senior Director, Clinical Quality Assurance at Beacon Therapeutics at Beacon Therapeutics. He possess expertise in gcp, sop, quality assurance, pharmaceutical industry, clinical trials and 18 more skills. Colleagues describe him as "Nick is a detail-oriented professional who will provide a level of quality and commitment that is not often seen these days. When it comes to interraction, it's worth noting that Nick is also very easy to work with, communicates well, and follows-through with his commitments."

Nick Piccoli's Current Company Details
Beacon Therapeutics

Beacon Therapeutics

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Senior Director, Clinical Quality Assurance at Beacon Therapeutics
Nick Piccoli Work Experience Details
  • Beacon Therapeutics
    Senior Director, Clinical Qiality Assurance
    Beacon Therapeutics Sep 2023 - Present
    Alachua, Florida, Us
  • Gyroscope Therapeutics (Acquired By Novartis Feb 2022)
    Director, Clinical Quality Assurance
    Gyroscope Therapeutics (Acquired By Novartis Feb 2022) Feb 2021 - Sep 2023
    Lead all aspects of clinical QA, partnering with internal customers (e.g., Clinical Operations) to successfully oversee and conduct Gyroscope’s clinical trials. -Establish and manage the GCP quality system, including authoring, reviewing, and approving Standard Operating Procedures and other applicable clinical documents (e.g., protocols, ICFs, project plans).-Provide GCP oversight and guidance to clinical project teams, including risk identification/mitigation of potential and identified operational issues/deviations. -Develop strategies and incorporate risk-based approaches across all audit types (internal, trial, vendor).Establish, implement, and execute Trial Audit Plans for all interventional trials.-Perform vendor qualification activities (Quality Agreements, Questionnaires, Audits) applicable to the risk level of vendors that support Gyroscope clinical trials.-Manage talent, employee performance, development, and engagement
  • Covance
    Senior Director, Audit And Inspection Management
    Covance Sep 2017 - Feb 2021
    Princeton, New Jersey, Us
    -Lead a team of 35 employees, overseeing their performance and development.-Develop strategies and incorporate risk-based approaches across all audit types.-Partner with Regulatory Compliance & Quality Assurance Executive Leadership to ensure alignment and continuity across the Quality Management System and identification of continual improvement opportunities.-Manage regulatory inspections and employee readiness planning and training.-Coordinate internal audit program to support 500+ sponsor studies.-Create and update the annual Master Audit Plan.-Manage talent, employee performance, development, and engagement
  • Chiltern
    Senior Director, Quality Assurance And Compliance
    Chiltern Sep 2015 - Aug 2017
    Durham, North Carolina, Us
    -Oversaw line management for 15 staff, conducting performance reviews and guiding training and career development.-Supervised regulatory inspections and client audits, assigning QA team members as representation.-Reported on metrics and escalated quality issues, liaising with executive staff, senior management and clients to address compliance issues and create action plans.-Produced QA controlled documents and reviewed staff billable rates on study budgets and proposals.-Implemented hybrid auditor approach to maximize agility of audit team.
  • Theorem (Now Chiltern)
    Director, Clinical Quality Assurance - Americas
    Theorem (Now Chiltern) Jun 2011 - Aug 2015
    Slough, Berkshire Sl1 4Aa, Gb
    -Supervised six CQA compliance management staff and led employee orientation sessions on SOPs.-Performed contracted and non-contracted audits, including conduct, reporting and follow-up.-Hosted all sponsor assessments and audits and regulatory agency inspections nationwide.-Created training and mentoring for new auditors and coordinated their annual accompanied audits.-Consulted on proposals and pricing and made revenue projections.
  • Omnicare Inc.
    Associate Director, Clinical Quality Assurance Americas
    Omnicare Inc. May 2009 - Jun 2011
    Cincinnati, Oh, Us
  • Omnicare Inc.
    Senior Manager, Clinical Quality Assurance
    Omnicare Inc. Jan 2007 - Apr 2009
    Cincinnati, Oh, Us
  • Omnicare Inc.
    Manager, Compliance
    Omnicare Inc. May 2002 - Dec 2006
    Cincinnati, Oh, Us

Nick Piccoli Skills

Gcp Sop Quality Assurance Pharmaceutical Industry Clinical Trials Cro 21 Cfr Part 11 Ctms Clinical Development Regulatory Affairs Edc Oncology Clinical Research Biotechnology Fda Regulatory Submissions Computer System Validation Auditing Budgets Validation Capa Management Gmp

Nick Piccoli Education Details

  • West Chester University Of Pennsylvania
    West Chester University Of Pennsylvania
    Organizational Psychology
  • Villanova University
    Villanova University
    Psychology
  • Conestoga Senior High School
    Conestoga Senior High School

Frequently Asked Questions about Nick Piccoli

What company does Nick Piccoli work for?

Nick Piccoli works for Beacon Therapeutics

What is Nick Piccoli's role at the current company?

Nick Piccoli's current role is Senior Director, Clinical Quality Assurance at Beacon Therapeutics.

What is Nick Piccoli's email address?

Nick Piccoli's email address is ni****@****nce.com

What is Nick Piccoli's direct phone number?

Nick Piccoli's direct phone number is +4417535*****

What schools did Nick Piccoli attend?

Nick Piccoli attended West Chester University Of Pennsylvania, Villanova University, Conestoga Senior High School.

What skills is Nick Piccoli known for?

Nick Piccoli has skills like Gcp, Sop, Quality Assurance, Pharmaceutical Industry, Clinical Trials, Cro, 21 Cfr Part 11, Ctms, Clinical Development, Regulatory Affairs, Edc, Oncology.

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