• Established and led Global Quality Organizations that are 100% compliant, effective, efficient, and sustainable.• Proven track record as a transformative Global Quality Leader with major pharmaceutical companies including Marken-a UPS company, Rutgers, Merck, Johnson & Johnson, Novartis, and Bristol- Myers Squibb.• An innovative and adaptive leader, who has consistently led by examples and with a vision for corporate strategies that translates the corporate goals into executable tasks. • Certified coach, facilitator, and mentor for Lean Six sigma Blackbelts and for various Quality functions. • Successfully designed and implemented corporate metrics systems, leading indicators, actionable qKPIs, and Quality surveillance programs.• Experience with multiple regulatory agencies (FDA, EMEA, MHRA, WHO) acting as the primary liaison with regulatory authorities regarding all Quality communications.• Strategic acumen to contribute at the executive committee level, strong entrepreneurial skills, and the ability to multi-task in a fast-paced environment.
Qsm Consultancy Llc
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Senior Consultant, Quality Systems; Pharmaceuticals And Biopharma And Clinical And Cold Chain LogisticsQsm Consultancy LlcEdison, Nj, Us
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Senior Consultant, Quality Systems; Pharmaceuticals/Biopharma/Clinical/Cold Chain LogisticsQsm Consultancy Llc Nov 2022 - Present
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Senior Vice President, Global Quality Assurance And Quality ControlMarken Aug 2019 - Jul 2022Durham, Nc, Us -
Vice President, Global Quality Assurance & Operational ExcellenceMarken Mar 2018 - Jul 2022Durham, Nc, Us• Designed and established the ‘Best in Class Quality Systems’ in the industry, a clear differentiator and competitive advantage for Marken’s excellent business growth record.• Reported directly to the CEO of the company as an active member of the executive committee responsible for all Quality matters globally. All stretch goals were achieved or surpassed across all four years.• Led, mentored, and managed 150 Global Quality leaders. (12 Regional Directors - Operational Quality Controls and QA as well as Global functional directors as direct reports)• Successfully hosted and passed more than 500 global audits from various regulatory agencies including FDA, EMEA, MHRA, WHO, ANVISA, and HSA as well as pharmaceutical companies such as Merck, GSK, Kite, JNJ, Pfizer, and Eli Lilly.
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Director Of Quality Assurance, Head Of QualityRutgers University Mar 2014 - Mar 2018New Brunswick, Nj, Us• Reported to the CEO as a member of Board of Directors responsible for designing and implementing custom Quality Systems for unique customer needs.• Introduced and embedded elements of GMP and GCP into the process and culture of the company, facilitating the transition of the R&D laboratory into a service provider for various pharmaceutical clients. -
Quality Systems And StandardsNovartis Consumer Health Mar 2013 - Feb 2014Basel, Baselstadt, Ch• As a ‘Chief of Staff’ and the deputy to Head, Quality Systems & Standards, administered budget, resource, and headcounts. Ensured the delicate balance and priorities between FDA commitments and other base business activities -
Site Quality Lead -Cd- External ManufacturingMcneil Consumer Inc., Johnson & Johnson Dec 2012 - Mar 2013New Brunswick, Nj, Us -
Consent Decree Facilitator / Associate Director, Quality Management SystemsMcneil Consumer Inc., Johnson & Johnson Nov 2010 - Dec 2012New Brunswick, Nj, Us• Facilitated execution strategy to address the Consent Decree for McNeil after the Tylenol recalls of 2010, completely transforming the company and culture to be acceptable to regulators.• Executed more than 4000 actions in timely manner avoiding any fine from the FDA and winning customers back • Led a team (11 direct reports and more than 200 indirect reports) of senior leaders, subject matter experts, and industry consultants who designed the new structured system containing corporate policies, 75 Level II Quality standards, and 100+ SOPs.• Trained more than 250 JNJ middle-management leaders on custom-designed Quality tools for remediation. • Established a new high performing Quality Management System team with a new platform for Quality Management Systems.
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Manager, Merck SigmaMerck Feb 2010 - Nov 2010Rahway, New Jersey, Us• Led compliance harmonization project upon merger of the two companies across 96 sites worldwide, identified redundancies in the process, and established new accountability guidelines. • Led the project management office for compliance and Consent Decree commitments and established clear communication channels for operational, tactical, and executive levels in the global organization.• Assisted the 24 International sites in evaluating compliance needs, assessing action plans, guiding implementation, and driving consistency across the sites through internal Quality system audits -
Project Manager, Global Quality Improvement / Manager, Global Quality SystemsMerck, Formerly Schering Plough Corp Apr 2003 - Feb 2010Development and implementaion of Key Performance Indicators for Global Metrics System.Contineous improvement activities and provide training to Green belts using Lean Sixsigma tools.Develop, Implement and Track Quality system implementation activities at 65 Sites worldwide ( FDA and Non FDA regulated Manufacturing sites, Animal Health sites).
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Black Belt Leansixsigma/ Gmp Investigation Team LeadDsm Pharmaceuticals 2002 - 2003Heerlen, Limburg, NlAs a part of the first wave of certified Black belts, successfully executed 6 value stream DMAIC projects, and multiple Kaizens in a regulated environment, resulting in free cash-flow of 2.1 million dollars and restored 5.6 million in inventory, earning a president award. -
Quality Scientist/ Quality EngineerBristol-Myers Squibb 1993 - 2002Lawrence Township, Nj, Us• Achieved 5 internal promotions within 9 years to various positions in QC and QA departments of this drug manufacturing site, starting as an Entry Level Scientist to Sr. Quality Engineer/QA Manager. • Performed method development and validation in an analytical laboratory setting for finished solid/liquid dosage using various methods including LC, GC, Dissolution, Particle-sizer.
Navnit Patel Education Details
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S. P. UniversityOrganic Chemistry
Frequently Asked Questions about Navnit Patel
What company does Navnit Patel work for?
Navnit Patel works for Qsm Consultancy Llc
What is Navnit Patel's role at the current company?
Navnit Patel's current role is Senior Consultant, Quality Systems; Pharmaceuticals and BioPharma and Clinical and Cold Chain Logistics.
What schools did Navnit Patel attend?
Navnit Patel attended S. P. University.
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