David Bonilla Email & Phone Number

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

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.

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.

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.

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.

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.

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.

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

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.

Us

Sampling and testing of raw materials, water, in-process samples and finished products. Served as point of contact to Laboratory Technicians.

Bachelor Of Science (Bs), Biology / Microbiology

Industrial And Product Design