Violet M. Carvalho Email & Phone Number

San Diego, Ca, Us

San Diego, California, Us

Head of Quality providing oversight of Quality Assurance across GLP, GCP GMP and Contract Service Providers.

San Diego, Ca, Us

Head of Quality providing oversight of Quality Assurance, Quality Control and Contract Service Providers and fostering collaborative, collegial relationships. • Drive Company Quality culture, continuous improvement and ensure approval of GxP documents.• Provide strategic leadership and mentor team members to enhance technical and soft skills.

San Diego, Ca, Us

Head of Quality providing oversight of Contract Service Providers and manufacturing partners, driving and influencing quality expectations and deliverables for Pfenex products.• Streamlined Quality Management Review and presented KPIs to leadership team.• Revamped Supplier Qualification and Audit program to be more efficient and effective.

Head of Quality providing oversight of Quality and Contract Service Providers in support of Pfenex projects.• Designed and implemented Veeva QMS and revamped Training Program, well received by internal customers.• Earned commendation for changing mindset of Colleagues, Clients and CSPs by fostering collaborative, collegial relationships.

Oversight of Quality Assurance and Contract Service Providers( drug substance, drug product, combination product) in support of Pfenex's lead biosimilar and CRM197.• Drove company Quality culture and continuous improvement to transform an R&D company into a commercially viable company. • Championed activities for approval of PF708, the firm’s first combination product, approved October 2019.• Reviewed all technical documentation and performed lot release for drug substance, drug product and device. • Led and provided guidance to staff on validation and commercialization activities of PF708.• Participated in responses to NDA related questions from FDA.• Co-chaired mock inspection sessions in preparation for FDA pre-approval inspection.• Achieved increased quality awareness and mindset change by establishing credibility with key stakeholders.

Directed Quality Systems activities to assure compliance, including major revamp of the Vendor Qualification, Quality Agreement, Audit, Lot release, Complaint and Material Review Board processes for commercial and clinical trial materials. • Established credibility with key stakeholders to achieve company goals collaboratively, spearheading Quality leadership for the early phase vaccine programs.• Championed activities focused on approval of Vaxchora, the firm’s first vaccine, approved June 2016.• Partnered in strategic planning with API CMO for FDA PAI, avoiding potential 483 observations.• Defined and communicated standards and improvement strategies to reduce variances and increase efficiency of Deviation, Change request and Corrective action programs.• Served as primary Quality contact with regulatory authorities, customers, CMOs.

Created environment of excitement, collaboration and determination to drive the cholera vaccine program through phase III, prepared for FDA PAI and gained FDA approval for the vaccine.•Hosted successful FDA PAI in February 2016, resulting in commendations and zero 483 observations. •Implemented continuous improvement initiatives and ignited/mobilized staff across departments to complete process validation and prepare for the FDA PAI. •Achieved increased Quality awareness and mindset change by implementing Quality metrics. Participated in Quality Management Review.•Reviewed source documents and CMC sections of INDs, BLA and responses to regulatory agency questions.•Proposed and led changes for significant improvements in the materials management program, equipment program, stability program and document approval process.• Established a cross functional change control board and managed the change control process.•Guided staff in review and approval of material and product specifications, master and executed batch records, test method validation, process and cleaning validation, stability studies, and analytical data. •Spearheaded the timely resolution/closure of investigations, deviations, and CAPAs•Hosted successful due diligence and customer audits•Participated in successful on-time qualification of the new facility and equipment within six months of initiating construction. •Participated as a QA Lead in successful CAL FDB audit of newly qualified GMP vaccine facility.•As QA point of contact, cultivated collaborative relationships with CMOs that facilitated timely resolution of issues and successful change to a new excipient vendor just prior to manufacture of vaccine consistency lots.•Prepared CMO Quality Agreements.•Chaired, mentored and fostered a collaborative, collegial environment within the cross functional CMC team.•As Research Integrity Officer for the firm, promoted ethical practices and adherence to Quality at all levels.

• Spearheaded the management and issuance of 40-plus new supplier quality agreements and ensured they were on track for completion within 5 months. • Led Quality audit of the firm’s Stability Program, logbooks and steered implementation of CAPAs.• Provided compliance oversight to deviations and trained initiators to focus on root cause and CAPA.

San Diego, Ca, Us

Introduced and implemented quality systems as a leader in the Quality Systems Department, with a focus on both development and commercial programs for solid oral dosage products. • Quality Assuranceo Key participant in successful FDA PAI at firm’s Swiss site in 2010 and in FDA audits at corporate US site.o Key participant in audits of US and European CMOs, CROs of API, drug product and due diligence audit of Swiss drug product facility resulted in highlighting and resolving gaps/deficiencies. o Led team in analytical review of CMC and supporting documents for firms first NDA, INDs and addressed potential CMC deficiencies.o Led and resolved complex OOS investigations involving multiple sites, and analytical lead in manufacturing related investigations and batch record review.o Reduced regulatory exposure with input to root cause/risk mitigation in deviations and CAPAs. o Provided oversight and strategy for Stability program of lead commercial product at corporate and contract sites in the US and Europe, and prevented CMC deficiencies.o Implemented and led the cross functional Cleaning Verification team and established program for product changeovers in multi product facility.• Quality Controlo Designed/revamped the reference standard program to maintain timely qualification, inventory and distribution of standards to 10 siteso Approved protocols, reports of stability, analytical method validation/method transfer to internal, domestic and international CROs.

San Diego, Ca, Us

Introduced and implemented quality systems.• Quality Assuranceo Set up and chaired a cross functional Material Specification Committee.o Established Cleaning Verification program in multi-product facility and led the cross functional team. • Quality ControlSuccessfully setup an independent Quality Control laboratory and a commercial QC team that prepared for the launch of Lorcaserin and a development QC team that focused on phase I/II programs.o Revamped the reference standard program for timely qualification/inventory control to serve ten sites.o Approved analytical method validation/method transfer protocols/reports for internal and CRO sites.o Reviewed test method validation protocols and reports for GLP analytical group.o Provided oversight/strategy for Lorcaserin stability program at corporate and contract sites in the US and Europe; prevented CMC deficiencies.

Ms, Oral Biology

Bachelor Of Science (Honors), Chemistry

Bachelor Of Education, Science, Math