• Lead strategic review and assessment of NDA/ANDA & BLA filings, providing timely recommendations.• Review OOS and manufacturing investigations for compliance with global regulatory expectations.• Collaborate with regulatory leads to design and execute regulatory strategies as necessary.

Remediation projects Investigations & Aseptic - Sterility Assurance lead.#Pharmaceuticals #Biotechnology #Combination Products

In this role, I was responsible for ensuring the thorough evaluation of deviations, out-of-specification results, and quality events, verifying root cause analysis was selected correctly, and recommending corrective and preventive actions (CAPAs). I collaborated with cross-functional teams to ensure compliance with regulatory requirements and internal standards, providing detailed reports and assessments to support continuous improvement and product quality. My expertise contributed to upholding global standards of excellence in pharmaceutical manufacturing and quality assurance.The project involved reviewing and assessing pharmaceutical investigations across manufacturing, global quality, and laboratory operations for a leading global pharmaceutical company.

• Conducted on-site reviews of CAPA verification for sterility assurance corrections in manufacturing, micro, and chemistry labs, this was in response to an FDA 483.• Reviewed aseptic techniques and smoke studies to ensure compliance with regulatory requirements.

Audit / identify deficiencies and, suggest/ Prep remediation plan for the drug products site.

PAI Aseptic Audit Lead. Vaccines, Sterile Injectables.

• Audit / Prep global sites (US, Europe & India) for regulatory audits. • Member of the Global Sterile Injectables Quality Leadership Team.• Led successful execution of quality/compliance improvement initiatives across sites.• Supported regulatory inspections and key investigations across Global Sterile Injectables sites.

• Managed quality leads (Sterility Assurance Quality Lead - Combination Products Quality Lead- Regulatory Lead- Validation Quality Lead - Micro & Chemistry Labs Lead - Complaints, Audits & Inspections Lead - Incoming and In process Quality Lead) to achieve quality, compliance and business objectives. • Actively engaged in activities to influence and meet the changing needs of the regulatory environment through QA and other appropriate venues.• Analyzed, developed and improved quality systems and associated business processes to achieve compliance with global regulatory requirements.• Developed and maintained policies, standards, procedures and guidelines encompassing all quality systems and, facilitated deployment.• Provided leadership in quality programs and initiatives; made recommendations to continuously improve systems.• Supported Design History File (DHF) projects.• Supported and fostered operational excellence across all functions – including Integrated Manufacturing Excellence – IMEx - implementation.• Supported investigation activities utilizing root-cause and problem-solving methodologies as well as supported CAPA development and implementation.• Contributed to the design and plan of validation studies• Developed and maintained department and site metrics for monitoring the critical process and Quality Attributes.• Reviewed and approved appropriate technical documentation in support of cross-functional and cross-departmental projects for all injectable products manufactured on site.

- Owned and ensured a robust investigation process for a site that had received an FDA warning letter, through the consistent and effective use of investigation system SOP/s and tools, and strong investigation culture across the site. This was a 24/7, 3 shifts, 1000+ team site.- Worked with site leadership and partnered with above site center colleagues to develop a robust site strategy and action plans for improving the Investigation system, as areas of opportunity are identified.- Ensured sufficient training and coaching resources are available and occur in a timely manner to meet site investigation goals.- Participated regularly and contributed to global discussion groups sharing information between the groups and the site colleagues, replicating practices, and promoting/enabling site colleague participation.

Provided strategic and tactical support to the Aseptic Processing Manufacturing areas, Quality Assurance and Quality Control Labs with a focus on activities and programs involving microbial and particulate control in aseptic production areas – cleaning and sanitization, disinfectants, Aseptic Training Programs, etc. Developed, directed and led Quality Oversight of aseptic production activities at the Brentwood campus for St. Louis Operations in the following areas: current GMPs, Regulatory/CMC, deviation investigations, corrective and preventative actions, batch record review, environmental control program, regulatory inspections and audits, change management, and contemporary product and process validation. Assured that Aseptic Manufacturing and Quality Assurance procedures and practices are aligned with Pfizer Quality Standards (PQS). This position led a team of managers and individual contributor direct reports (group size 75+ Contracted Resources) with a wide range of quality compliance responsibilities within Quality Assurance.External Supply Quality for products contracted products onsite.

Led a talented team of Quality Operations Professionals, In process Quality with the oversight and accountability for injectable Solutions drug products at the site. Focus on sterile medical device- Combination Products injectors for the civilian and armed services.Contract manufacturing process review and communications POC.

Led a talented team of Quality Operations Professionals and had the ultimate oversight and accountability for Sterile Solutions and Suspensions, Biologics injectables drug product at the Kalamazoo site (largest Aseptic site in Pfizer's network, the position was in charge of 44 Sterile Drug Products), as well as GMP site support. Sterile products, freeze dried, gamma irradiated, Ethylene Oxide sterilized, Heat treated and Biologics.Provided consultation and guidance on health authority regulations and Pfizer standards for project teams and quality oversight responsibilities. Recommended and implemented initiatives related to quality and compliance improvement.Responsible for:• Design, implementation and management of selected quality systems.• Development of procedures and practices in collaboration with relevant customer groups.•Ensure cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. •Experienced in remediation plans and executions, building quality teams and quality systems.

Evaluated data and released raw materials, packaging, and Pfizer produced products (Animal Health and Human Health injectable Products) that conform to corporate, customer, and regulatory standards. Maintained associated test plans. Conducted and reviewed non-conformance investigations related to the manufacturing, packaging, testing of product, sterility assurance, and all other GMP functions. Provided guidance and oversight in identifying root cause and preventative corrective action. Led and reviewed formal risk assessments. Assigned release recommendations to implicated materials. Evaluated and approved permanent changes to manufacturing and packaging equipment and processes, testing, IT systems and other GMP documents and programs. Reviewed and helped develop product and process validation strategies. Evaluated product data annually and wrote Annual Product Review Reports. Maintained Quality Systems and ensured that products conform to regulatory, and Pfizer Quality Standards. Participated in internal GMP audits and supported customer and regulatory audits. Provided product knowledge and support for regulatory responses, regulatory annual reports, and the development of other regulatory submission packages. Maintained knowledge of product filings to support inquiry responses from internal and external customers.

Provided Quality Assurance site support for Pfizer's Biologic Analytical Laboratories(PBAL)- Biopharma and stability operations.Contract Drug Substance Management oversight for the manufacturing of biologic drug substance Human Growth Hormone/ Stagnant and drug product.#ProteinPurification #Biopharmaceuticals#MonoclonalAntibodies #RecombinantProteins

Supported In-process Liquids - Powders - Tablets manufacturing (Tableting, Coating, Drilling / Drying, and printing of tablets), capsules production - filling - Packaging of all products in powders, liquids, capsules and tablet forms. more than 50 products manufactured.

Oral Products Manufacturing •Assigned personnel to manufacturing tasks, focusing on above 95% schedule attainment. •Reviewed all batch documentation, entered data into all required computer systems•Investigated and ensured approval of Quality assurance reports, Events / Change Controls •Implemented a documentation system in the plant that decreased documentation deviations by more than 35% which improved RFT Doc Index to above 95%

•Manufactured oral liquid batches using appropriate techniques.•Maintained, completed and reviewed lot records.•Leader of Liquids Compounding area\Packaging Safety Team that reduced injuries by more than 40%

Developed and validated a variety of analytical methods for finished products for Solid Dosage, including HPLC, Dissolution and various other test methods.