Therese Leggiere, Rac Email & Phone Number

Seattle, Washington, United States

Experienced Quality Management professional with demonstrated success working in BioTech and Medical Device developing and maintaining quality and compliance programs in FDA and ISO regulated industries. Skilled in CAR-T Therapy, GMP, Regulatory, Quality Metrics, Investigations, Regulatory Body Inspection Management, and Quality Remediation Projects.

Seattle, Washington, United States

Oversaw QA for 200+ global apheresis sites focused on cell therapy development for a biopharmaceutical company that develops autologous T-cell immunotherapies for B-cell lymphoma- Managed the Global QA Patient Operations budgetary plans, daily operations, QA process implementations, and a team of 19 QA professionals across United States, Europe, and Japan - Managed apheresis sites, supporting deviations, complaints, and troubleshooting of logistics processes- Spearheaded… Show more Oversaw QA for 200+ global apheresis sites focused on cell therapy development for a biopharmaceutical company that develops autologous T-cell immunotherapies for B-cell lymphoma- Managed the Global QA Patient Operations budgetary plans, daily operations, QA process implementations, and a team of 19 QA professionals across United States, Europe, and Japan - Managed apheresis sites, supporting deviations, complaints, and troubleshooting of logistics processes- Spearheaded investigations and root cause analyses to understand and identify trends in deviations- Implemented effective quality systems, ensuring all employees were trained and proficient in processes- Partnered with apheresis sites and legal team to negotiate, draft, and align external quality agreements- Led the auditing team as quality audits were scheduled and performed within the apheresis sites- Hosted regulatory inspectors, including FDA (CDRH and CBER), Notified Bodies, EMA, and JNDA- Maintained a knowledge of apheresis collection processes to improve logistics with GMP manufacturing - Functioned as the SME in communications with the FDA and global regulatory authorities- Developed due diligence assessments, quality agreements, and client work instructions to bring US contract manufacturing organization (CMO) operations online for drug manufacturing and warehousing Key Accomplishments:- Established a global quality function that offered quality management reviews to senior leadership and provided visibility to the health of the quality system for the patient operations team, resulting in a 45% improvement on compliance factors and a 90% improvement for on-time deviations and CAPA closures- Expanded the US audit quality program into EU, and led efforts to assess regional requirements in EU to map and leverage health authority inspections at apheresis sites, reducing auditing burden by 50%+- Created a troubleshooting guide that resulted in a 50%+ decrease in time spent on resolutions Show less

Seattle, Washington, United States

- Created the Global Apheresis Site Audit program, which included training to qualify internal and contracted auditors to perform audits specialized by region for over 200 sites in NA, EU, and Japan- Managed the hiring, performance reviews, training, and performance plans for a QA team in the US- Built and developed the global teams in Europe and Japan as the company’s global footprint expanded- Trained all new hires, overseeing performance and progression while fostering best… Show more - Created the Global Apheresis Site Audit program, which included training to qualify internal and contracted auditors to perform audits specialized by region for over 200 sites in NA, EU, and Japan- Managed the hiring, performance reviews, training, and performance plans for a QA team in the US- Built and developed the global teams in Europe and Japan as the company’s global footprint expanded- Trained all new hires, overseeing performance and progression while fostering best practices adoption- Led negotiations for apheresis site quality agreements for clinical and commercial collections at apheresis sites and third-party locations, drafting templates and collaborating with legal to finalize- Implemented new electronic systems for quality systems and resolved any implementation challenges- Represented quality in the development of a customer service and scheduling portal for Global Patient Operations, offering feedback and approving all relevant record and template changes to the software- Provided Quality Assurance oversight for relevant Patient Operations change control processes, impact assessments, and resulting action execution to ensure compliance and functionality with processes- Managed budgets for Patient Operations Quality, allocating funds and reducing costs appropriately- Analyzed data sets on deviations, complaints, and troubleshooting to identify trends and resolutions- Subject matter expert and back room support for multiple mock inspections to prepare for FDA pre-approval inspections (PAI)Key Accomplishments: - Developed and implemented apheresis site quality audit processes for the United States, and then effectively expanded processes into Japan, determining regulations and opening 6 sites in 9 months- Coordinated cross-functional teams to perform a QADV on the Business License Application (BLA) for the FDA, which brought the immunotherapy drug, Breyanzi, from the clinical to commercial phase Show less

Seattle

- Managed a team of 40+ QA and RA professionals in 4 facilities across North America and Argentina for a leading newborn care, neurology, sleep, hearing, and balance medical device manufacturer- Oversaw strategic executions of worldwide product registrations in US, CA, LAT, APAC, and EMEA - Rewrote quality processes for clear compliance and established change control process documentation- Functioned as manager and SME of essential quality system elements, such as QMS reviews… Show more - Managed a team of 40+ QA and RA professionals in 4 facilities across North America and Argentina for a leading newborn care, neurology, sleep, hearing, and balance medical device manufacturer- Oversaw strategic executions of worldwide product registrations in US, CA, LAT, APAC, and EMEA - Rewrote quality processes for clear compliance and established change control process documentation- Functioned as manager and SME of essential quality system elements, such as QMS reviews, supplier selections, material review boards, CAPA, change review boards, complaints, DHR reviews, and risks - Created engineering documentation for existing devices that filled in the gaps with FDA expectations, allowing older devices to be utilized as predicate devices in the approval process of new devices - Hosted FDA, ISO, and Health Canada regulatory inspections as the designated management representative, and provided support with multiple quarterly safety inspections across agencies - Spearheaded company-wide implementations of Agile Quality Module, an electronic management system, and eLeaP, a learning management system, delivering system training to all employees - Developed and maintained metrics for quality systems for QMR presentations to leadership Key Accomplishments: - Successfully rebuilt and implemented a compliant Quality System to bring the Seattle facility out from under an FDA Warning letter in less than 2 years with more quality-minded SOPs and trainings - Streamlined the implementation of a new electronic QMS and ERP system, which allowed for simultaneous review by multiple people and a 50%+ increase in training documentation accuracy- Oversaw manufacturing and registration of 15+ Class I, II, and III medical devices, generating $50M P&L Show less

Seattle, Washington, United States

Seattle, Washington, United States

Seattle, Washington, United States

Seattle, Washington, United States

Redmond, Washington, United States

Renton, Washington, United States

Ferndale, Washington, United States