David Grote

Providing business and regulatory strategy, Expert GxP Compliance, cGMP Capacity and US onshoring services to Life Science companies.

Partner with leading biopharma to elevate GxP Quality and Regulatory operations from a reactive cost center to a driver of commercial success. My strategy focuses on cost-effectively ensuring robust compliance, accelerating product development and unlocking market potential. I provide executive-level guidance to navigate the full product lifecycle—from clinical trials to global commercialization—by building scalable, compliant, and cost-effective quality frameworks. Key Strategic Services: • Inspection Readiness & Remediation: I guide organizations through critical regulatory challenges, like remediation of compliance gaps such as FDA Warning Letters and product recalls. I cost-effectively overhaul quality systems to ensure continuous inspection success and agency approval. • Leading innovation: For new technology, equipment and service providers, I help break through barriers to change and enable rapid commercialization and growth of products with transformative potential in life sciences. • Operational Excellence & Efficiency: I resolve QMS bottlenecks and inefficiencies. I use tools like opex, AI, and digital solutions to drive significant gains in efficiency, inspection success, and right-first-time performance. • Predictive Quality & Risk Management: I leverage analytics and AI to detect risk and prevent of issues. This enables optimal resource allocation for global vendor, study site and CDMO audits- cost effectively minimizing threats before they impact. • Talent Development & Empowerment: My training empowers your team with the GxP and leadership skills needed for sustained success in today’s dynamic regulatory landscape while building a quality culture that drives excellence. My extensive network includes senior industry leaders and top international experts in GxP quality, regulatory, CMC and medicine. I maintain strategic partnerships with leading AI, tech, and GxP vendors to bring you the most innovative solutions.

Led GxP Quality for a global commercial & clinical biopharmaceutical company, ensuring operations align with international regulatory standards. Managed global cross-functional quality teams to maintain a robust quality management system and uphold HTA, GLP, GCP, GMP and GDP compliance. Designed and implemented efficient systems for quality assurance, vendor oversight, audits, and training to unlock continuous improvement, maximize efficiency and minimize risk. Oversaw compliance for more than 140 GxP vendors, collaborating across departments to ensure alignment and operational excellence. • Drove implementation of a transformative eQMS (Veeva). • Expertly led a global commercial product recall for a stability issue, ensuring regulatory compliance and safeguarding patient safety while mitigating company risk and impact. • Pioneered the use of AI-driven deep research tools to improve audit program and quality risk analysis. • Supported FDA, EMA, MHRA, and global approval for commercial product leading to net sales of $310M in 2024 and significant growth since. • Led global GCP and GMP Quality oversight across a robust clinical pipeline, including multiple global active phase 3, phase 1/2 and Phase 1 trials in oncology, infectious disease, and autoimmune indications. • Ensured success for multiple regulatory GxP inspections internally and within vendors, clinical study sites and partners, including recent HPRA and MHRA GDP inspections to maintain EU and UK Wholesale Distribution Authorisation (WDA) licenses. • Drove training compliance from below 70% to above 90% across the organization while targeting curricula to maximize impact. • Spearheaded the development of innovative GxP onboarding and annual refresher training, significantly boosting staff impact and overall value •Transformed quality management with comprehensive QMS metrics, enabling leadership to swiftly pinpoint trends, proactively fix issues, and effectively minimize risk.

Led quality assurance across all of Teva’s innovative and biosimilar biologics R&D programs, supporting progress of multiple products from pre-clinical development through to commercial approval. I oversaw QA processes for both internal operations and external contract manufacturers, ensuring full compliance with regulatory requirements. I provided leadership in the design, buildout, and operation of cGMP Biologics Manufacturing Facilities, integrating advanced single use technologies to optimize performance. I also led global regulatory submission strategies and inspection readiness efforts to achieve successful approvals and business objectives. Key Achievements: Spearheaded the development of well-characterized and efficient manufacturing processes and analytical assays, facilitating successful technology transfer from development to commercial scales. Ensured readiness for Pre-Approval Inspections (PAI) and other regulatory inspections for commercial sites. Led QA for the construction and operation of a cGMP Biologics Manufacturing Facility featuring state-of-the-art disposable bioreactor technology, Cell Banking, and Fill Finish operations - DS operational within 18 months. Extensive experience managing Drug Substance (DS) and Drug Product (DP) CMOs internationally, including in the US, EU, and South Korea. Successfully led inspection readiness efforts at a South Korean CDMO, addressing a warning letter issued in January 2018, which culminated in the approval of Ajovy in September 2018. Recognized as a Subject Matter Expert (SME) in biologics manufacturing, providing QA consulting for a large-scale Teva commercial biologics manufacturing facility under construction in Ulm, Germany. Contributed to successful submission and approval of multiple successful IND and BLA filings across biologics programs including drugs and combination products.

I steered quality assurance efforts for Teva Biopharmaceuticals USA, maintaining efficient yet rigorous cGMP standards across operations. I oversaw the decommissioning and relocation of manufacturing and laboratory facilities, ensuring quality was preserved seamlessly throughout the transition. I conducted comprehensive audits across multiple global sites, including laboratories, bulk drug substance production, Active Pharmaceutical Ingredient manufacturing, Vaccines, and solid oral dosage manufacturing. I worked closely with cross-functional teams to align quality initiatives with broader company goals and strategic priorities. • Led QA efforts to restart cGMP biologic drug substance manufacturing on an accelerated timeline. • Addresssd severe deficiencies in the quality management system, quickly removing bottlenecks to enable clearing of backlogs and improve compliance without adding cost. • Executed cGMP training programs for operators to bolster site-wide quality culture and adherence.

For many years I taught a two- day course 2x per year on Risk Based Validation for Biopharmaceutical, pharmaceutical, and medical device industry professionals.

As a cGMP compliance expert, I led the development of regulatory compliance strategies, internal audits, and coordination of regulatory agency and partner audits and inspections. I spearheaded “pressure test” preparations for regulatory Inspections, ensuring continual readiness and success. Key Achievements: Directed the completion of validation work and performed gap analysis and mitigation for Amgen’s Biovex acquisition in Woburn, MA, and Abingdon, UK. Ensured adherence to validation and filing timelines, culminating in the successful launch of IMLYGIC™ (talimogene laherparepvec).

Ensured success of concurrent multiproduct commercial manufacturing at one of the world’s largest biopharmaceutical facilities, with 180,000 L of production bioreactor capacity. During my leadership, the plant received Amgen’s “Best Plant” award in 2012. Key Responsibilities and Achievements: Managed new product introductions and led the rapid resolution of significant manufacturing issues to minimize impact. Played a key role in all site regulatory inspections and regulatory filing submissions, RFIs, and reviews. Built and developed a high-performing, multilevel team, experts in MSAT, that delivered quality results on aggressive timelines. Conducted technical investigations and drove corrective/preventative actions (CAPA) and major improvements. Led the team responsible for writing the manufacturing sections of the BLA/ other submissions and answering RFIs for multiple products.

• Led the conversion of the ARI site to concurrent multiproduct manufacturing, overseeing quality and validation for new product introductions. • Developed segregation and changeover practices, enabling the site to handle over 100 lots annually. • Authored the FDA submission for site conversion and successfully presented multiproduct operating controls to regulatory agencies.

• Led start-up validation of one of the world's largest biopharmaceutical manufacturing facilities, including Process valdiation, CIP, SIP, EM, Washers, Autoclaves, and Utilities. • Established the site's validation philosophy and key operating procedures. • Managed a multi-level team of validation engineers and over 30 contract staff, completing the project in record time with a very successful FDA PAI and subsequent approval. • Actively participated in and successfully defended audits from both the FDA and EMEA. .

Led and executed validation activities for a large-scale biopharmaceutical facility retrofit, including IQ, OQ, SIP PQ, process validation, and change control. • Developed and implemented the site validation philosophy, generating and reviewing validation protocols, reports, master plans, and SOPs. • Conducted critical gap analyses and successfully defended validation packages during FDA PAI and EMEA audits. • The project successfully met the critical supply shortage for Enbrel™.

• Managed contract validation projects, ensuring compliance and quality for client companies. • Developed and executed equipment qualification and validation protocols for Stryker Biopharmaceuticals. • Authored steam quality-testing SOP and supported EMEA audit defense initiatives. • Contributed to the development of cleaning and sterilization validation philosophy, enhancing operational standards.

• Identified shortcomings in validation packages and drafted IQ, OQ, and PQ protocols for various equipment. • Executed cleaning validation and participated in FDA PAI and MCA audits, ensuring compliance with regulatory standards. • Supervised validation projects and trained temporary employees, enhancing team efficiency and expertise.

• Operated bioreactors, homogenizers, centrifuges, and purification equipment in a cGMP biologics pilot plant. • Conducted troubleshooting and contamination investigations to maintain operational integrity. • Developed expertise in SIP, CIP, and various cell culture techniques, including bacterial and mammalian systems.