David Bonilla

David Bonilla Email and Phone Number

Director of Commercial Quality & Compliance-Quality Assurance | Compliance driven | Optimizing cost efficiency and post market operations. | Promoting process improvement and customer engagement. @ Teva Pharmaceuticals
David Bonilla's Location
Quakertown, Pennsylvania, United States, United States
David Bonilla's Contact Details

David Bonilla personal email

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About David Bonilla

𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐢𝐬𝐧’𝐭 𝐣𝐮𝐬𝐭 𝐚 𝐩𝐫𝐨𝐜𝐞𝐬𝐬—𝐢𝐭’𝐬 𝐚 𝐩𝐫𝐨𝐦𝐢𝐬𝐞. Every successful organization has a story of perseverance, innovation, and impact. Throughout my leadership in the pharmaceutical industry, I’ve upheld this promise by overseeing quality assurance, post-market commercial quality operations, compliance, and process optimization. I’ve transformed challenges into opportunities, driving cost savings, elevating customer satisfaction, and ensuring flawless regulatory compliance. By fostering a culture of continuous improvement, I’ve built frameworks that deliver measurable impact, 100% compliance, and long-term value.From overseeing product release, quarantine, and disposition to partnering with global regulatory agencies like the FDA, Health Canada, ANVISA, and DEA, I’ve aligned compliance with innovation to achieve sustainable success. My expertise spans cGMP compliance, ISO 9001:2008, GMA Safe standards, and microbiology, ensuring operational excellence and regulatory readiness. I’ve driven inspection readiness, implemented remediation strategies, and co-authored publications that shape industry best practices.𝐅𝐨𝐫 𝐦𝐞, 𝐥𝐞𝐚𝐝𝐞𝐫𝐬𝐡𝐢𝐩 𝐦𝐞𝐚𝐧𝐬 𝐢𝐧𝐬𝐩𝐢𝐫𝐢𝐧𝐠 𝐭𝐞𝐚𝐦𝐬 𝐭𝐨 𝐫𝐞𝐚𝐜𝐡 𝐭𝐡𝐞𝐢𝐫 𝐟𝐮𝐥𝐥𝐞𝐬𝐭 𝐩𝐨𝐭𝐞𝐧𝐭𝐢𝐚𝐥. By mentoring, coaching, and empowering cross-functional groups—even beyond my direct supervision—I’ve cultivated collaborative environments that deliver results. I’m recognized with multiple awards for collaborative leadership and process improvements.𝐄𝐟𝐟𝐢𝐜𝐢𝐞𝐧𝐜𝐲 𝐡𝐚𝐬 𝐛𝐞𝐞𝐧 𝐚 𝐡𝐚𝐥𝐥𝐦𝐚𝐫𝐤 𝐨𝐟 𝐦𝐲 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. I established an Independent Commercial Quality Organization, forging alliances with Health Canada, designing a sustainable budget, recruiting top-tier talent, and implementing robust processes for product release, solidifying Teva’s regulatory compliance in the Canadian market. Consolidating five distribution centers into three saved $1M annually. Securing ISO 9001 certification across Americas sites elevated trust and operational excellence. During Allergan’s acquisition, I oversaw operations across four distribution centers and recall processes, achieving zero audit observations at two manufacturing sites. 𝐁𝐮t 𝐦𝐲 𝐰𝐨𝐫𝐤 𝐢𝐬 𝐚𝐛𝐨𝐮𝐭 𝐦𝐨𝐫𝐞 𝐭𝐡𝐚𝐧 𝐦𝐞𝐭𝐫𝐢𝐜𝐬: Every audit, project, and improvement are a step toward safer, more effective products for patients worldwide. Let’s connect to explore how I can bring my experience and dedication to your organization, driving quality, compliance, and operational success to the next level.

David Bonilla's Current Company Details
Teva Pharmaceuticals

Teva Pharmaceuticals

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Director of Commercial Quality & Compliance-Quality Assurance | Compliance driven | Optimizing cost efficiency and post market operations. | Promoting process improvement and customer engagement.
David Bonilla Work Experience Details
  • Teva Pharmaceuticals
    Director Commercial Quality Usa
    Teva Pharmaceuticals Apr 2017 - Present
    Tel-Aviv, Il
    Head of Commercial Quality for Teva's in USA, Responsible for all post market activities related to the company extensive portfolio of products. • Promoted to head strategic post-market operations across Canada and the U.S. overseeing $1.5M budget and interfacing with regulatory agencies and customers while upholding compliance and product integrity.• Cultivated strategic partnership with Health Canada and established an Independent Commercial Quality Organization within Canada by developing an operating budget model, securing funding, executing processes, and building top talent to oversee product review, release, and management. • Co-developed an internal communication process that reduced reporting timelines from weeks to days, preventing costly non-compliance penalties.• Spearheaded biweekly FDA engagements, accelerating compliance reporting and expediting approvals to prevent drug shortages.• Pioneered cost-saving initiatives by implementing a remote work policy for the Complaints Management Team, driving $150K in annual savings, and establishing Quality Councils and Management Reviews to create cost efficiencies, enhance visibility, and improve "right-first time" outcomes.• Influenced product portfolio decisions in Sales & Operations (S&OP) meetings, aligning quality objectives with business goals for expedited launches.• Shortened FDA notification timelines from 6 to 2-4 months, overhauling regulatory processes to ensure seamless supply chain continuity.• Developed a transition plan for secondary packaging operations from contractor outsourcing to in-house execution at a new location, resulting in significant cost savings.• Winner of multiple Teva Star awards for collaborations and support from FY 2015 to FY 2024
  • Teva Pharmaceuticals
    Associate Director-Commercial Quality And Compliance
    Teva Pharmaceuticals Jan 2017 - Jan 2021
    Tel-Aviv, Il
    • Achieved $200K in annual savings by consolidating product quality complaint intake operations, eliminating redundancy, and transferring knowledge and headcount between sites.• Provided strategic leadership to Commercial Quality USA during the Actavis Generics acquisition, overseeing 4 Distribution Centers, Regulatory Compliance, and Recall processes.• Directed critical functions such as FDA Drug Shortage Reporting, Learning Management Systems, Teva Master Data, Supplier Master Data& Document Control, and SAP Distribution Center Quality operations.• Realized over $1M in annual savings and $300K in Quality cost reductions by amalgamating 5 distribution centers into 3 optimized facilities.• Saved $200K annually by unifying 2 Complaint Intake Centers and delivered additional savings of $300K by transferring complaint closure responsibilities to the relevant departments and manufacturing sites, eliminating redundancy while empowering SMEs to handle documents efficiently and accurately.• Integrated Regulatory Compliance into the Commercial Quality organization, dismantling silos and steering operational consistency-ensuring 100% FDA compliance in recalls and field alerts.• Strengthened organizational reputation for reliability and compliance through enhanced post-market quality processes and timely regulatory reporting.• Developed and trained the Complaint Intake Center team to support Teva’s innovative Digihaler product line, serving as a help desk for mobile app-integrated inhalers.
  • Teva Pharmaceuticals
    Associate Director- Quality Assurance Services And Compliance
    Teva Pharmaceuticals Apr 2015 - Jan 2017
    Tel-Aviv, Il
    • Led Teva Pharmaceuticals' Product Quality Complaints process, managing a team of 16 professionals across the USA and India complying with FDA regulations, and overseeing 50% of all company complaints.• Directed intake and closure of 1,000+ annual product quality complaints, ensuring compliance with company policies and FDA regulations with a focus on timely response, classification, and closure metrics.• Executed a robust complaint tracking and trending process, providing actionable insights to Commercial and Sales teams to enhance product quality.• Systemized complaint management process reducing critical complaint processing from two days to same-day reporting and non-critical complaints to one day.• Drove collaboration with Pharmacovigilance, enhancing complaint and adverse event reporting compliance, and co-managed FDA inspection of the Quality and Pharmacovigilance Departments.• Empowered and coached a high-performing team, enhancing product knowledge to prevent misuse and improve patient and healthcare provider support, driving operational efficiency and compliance.
  • Spi Pharma
    Head Of Quality, Delaware Sites
    Spi Pharma Jan 2013 - Apr 2015
    Wilmington, De, Us
    • Headed the Quality Assurance and Quality Control department for the manufacturing of API and excipients complying with global regulations (21 CFR 210 & 211, ICH Q7, ISO 9001:2008) and guidelines, including FDA, ANVISA, and EU standards.• Strengthened customer confidence in company products by streamlining processes, managing audits, and building relationships with global and local pharmaceutical clients while acting as the primary interface for supplier and customer communications, enhancing trust and collaboration.• Accomplished zero observations in audits by leading quality assurance across 2 manufacturing sites, ensuring full regulatory compliance and maintaining exceptional quality standards.• Reduced non-conformances and improved quality systems by establishing and leading Quality Councils, streamlining CAPA processes, and executing effective resolution strategies.• Enhanced product quality and compliance by revamping staffing and coaching initiatives, leading to higher customer ratings and adherence to GMP standards.• Directly supervised Contract Manufacturing Organizations (CMOs), driving continuous improvement and enforcing strict adherence to quality control standards and regulatory compliance throughout the drug product cycle and finished product manufacturing process.• Instituted a culture of heightened compliance to improve product cycle time to meet established standards and customer expectations collaborating with cross-functional teams.
  • Colorcon
    Director Qa/Qc Americas
    Colorcon Apr 2010 - Oct 2012
    Harleysville, Pa, Us
    • In charge of Quality Systems for the Americas, overseeing Corrective and Preventive Actions (CAPA), investigations/deviations, non-conformance reviews, product release, document and quality control, and complaint handling programs.• Directed a team of 50 quality professionals across the Americas, including Puerto Rico and Latin America, overseeing a $3M+ departmental budget.• Established performance metrics and KPIs, including product cycle time reduction, first-pass yield, audit findings, and customer satisfaction scores aligningwith business goals and regulatory requirements.• Managed external CMO operations, optimizing intermediate product processing to improve quality, efficiency, and cost-effectiveness.• Orchestrated the implementation of Six Sigma and FMEA, streamlining batch processing and product release by eliminating non-value-added activities, boosting throughput, and reducing cycle times.• Secured ISO 9001 certification for all Americas sites within a year, overcoming geographical and resource barriers, establishing consistent quality processes, and elevating customer satisfaction.• Identified customer needs and implemented targeted quality strategies that improved financial efficiencies, enhanced satisfaction, increased retention and unlocked new business opportunities.
  • Johnson & Johnson
    Quality Assurance Manager
    Johnson & Johnson 2001 - Jan 2010
    New Brunswick, Nj, Us
    Supervised a staff of 15 in all aspects of the Microbiology Laboratory for the testing of raw materials, solid and liquid pharmaceutical products. Responsible for the department budget of over $1,000,000. Subject matter expert in Microbiology, frequently interacted with FDA and other regulatory agencies.
  • Johnson & Johnson
    Quality Assurance Manager, Compliance And Qc/R&D Microbiology
    Johnson & Johnson 2001 - 2001
    New Brunswick, Nj, Us
    Appointed to lead and supervise the Quality Assurance and Quality Systems while maintaining the QC Microbiology Laboratory responsibilities for a 6 month period.
  • Cordis
    Quality Assurance Manager, Compliance And Qc Microbiology
    Cordis 2004 - 2004
    Miami Lakes, Fl, Us
    Selected for a special assignment for 4 months to lead the Quality and Compliance aspects of the company in the Microbiology area at the San German PR site
  • Mcneil Consumer & Specialty Pharmaceuticals
    Supervisor Microbiology
    Mcneil Consumer & Specialty Pharmaceuticals 1996 - 2001
    Supervised a staff of 15 Microbiologists in all aspects of the Microbiology Laboratory.- Trained personnel on cGMP - Created and approved Standard Operating Procedures (SOP)- Wrote investigations- Reviewed and approved protocols, equivalency studies and investigations.
  • Mcneil Consumer Healthcare
    Microbiologist
    Mcneil Consumer Healthcare Mar 1994 - Mar 1996
    Us
    Sampling and testing of raw materials, water, in-process samples and finished products. Served as point of contact to Laboratory Technicians.

David Bonilla Skills

Gmp Capa Fda Quality System Quality Assurance Sop Validation Pharmaceutical Industry Quality Control Change Control Glp Pharmaceutics Lims Cross Functional Team Leadership Six Sigma Quality Auditing Gxp Cleaning Validation Microbiology Technology Transfer Medical Devices 21 Cfr Part 11 Laboratory Quality Management Fmea Fda Gmp Computer System Validation Iso 9000 Standard Operating Procedure Dea Project Management Leadership Consumer Products Complaint Management Purified Water Supervision Risk Management Internal Audit Cgmp Manufacturing Laboratory Information Management System U.s. Food And Drug Administration Good Laboratory Practice Corrective And Preventive Action

David Bonilla Education Details

  • Kansas State University
    Kansas State University
    Biology / Microbiology
  • Temple University
    Temple University
    Industrial And Product Design

Frequently Asked Questions about David Bonilla

What company does David Bonilla work for?

David Bonilla works for Teva Pharmaceuticals

What is David Bonilla's role at the current company?

David Bonilla's current role is Director of Commercial Quality & Compliance-Quality Assurance | Compliance driven | Optimizing cost efficiency and post market operations. | Promoting process improvement and customer engagement..

What is David Bonilla's email address?

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What is David Bonilla's direct phone number?

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What schools did David Bonilla attend?

David Bonilla attended Kansas State University, Temple University.

What skills is David Bonilla known for?

David Bonilla has skills like Gmp, Capa, Fda, Quality System, Quality Assurance, Sop, Validation, Pharmaceutical Industry, Quality Control, Change Control, Glp, Pharmaceutics.

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