Rita Boucher Email and Phone Number
Quality pharmaceutical professional | 30 years in industry | Aseptic processing and TS operations | Sterile injectables | cGMP | Continuous Improvement | CDMO Experience at
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Sharp Services
Rita Boucher's Location
Valdese, North Carolina, United States, United States
Rita Boucher's Contact Details
Rita Boucher work email
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Rita Boucher personal email
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About Rita Boucher
Accomplished Quality leader with thirty years of pharmaceutical experience driving change in a regulated manufacturing environment. Extensive experience with small molecule, sterile injectable products. Change leader for multiple initiatives creating new, more efficient processes while focusing on results and maintaining line of sight to a strategic vision.
Rita Boucher's Current Company Details
Sharp Services
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Quality pharmaceutical professional | 30 years in industry | Aseptic processing and TS operations | Sterile injectables | cGMP | Continuous Improvement | CDMO Experience
Rita Boucher Work Experience Details
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Vice President, Quality Sps-UsSharp Services Feb 2024 - PresentAllentown, Pa, UsProvide executive leadership of three US facilities engaged in commercial packaging services. Responsible for leading the Pharmaceutical Quality System in US Commercial Packaging, driving a culture of Quality at each facility to enable a Quality maturity model that focuses on prevention, harmonizing Quality practices across the facilities to create efficiencies, improving customer satisfaction and driving sustainable regulatory compliance. A member of the global Quality leadership team.
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Vice President Of Quality AssuranceExela Pharma Sciences Llc Apr 2021 - Mar 2023Lenoir, Nc, UsResponsible for the design, implementation, and management of Exela’s quality systems. Led Quality teams in the adherence to regulatory requirements and industry best practices. Quality oversight of CDMO relationships.• Managed multiple quality functions including quality assurance, sterility assurance, microbiology and chemistry laboratories, change control, investigations, documentation control, compliance, training, and validation• Continually assessed quality systems for opportunities for improvement and drove identified initiatives through implementation • Provided leadership and guidance managing relationships with CDMO’s Quality Assurance -
Chief Quality OfficerNephron Pharmaceuticals Mar 2020 - Dec 2020West Columbia, South Carolina, UsResponsible for leading the site’s Quality organization to ensure conformance to all regulatory requirements associated with the manufacture of pharmaceutical and 503b outsourced products.• Managed employees across multiple quality functions including quality assurance, quality control, investigations, documentation control, product disposition, and compliance• Quality contact for all regulatory interactions including inspections and communications• Ensured robustness and adherence to defined quality systems• Assessed risks associated with manufacturing practices to ensure the safety, efficacy, and quality of marketed products -
Quality Operations DirectorPfizer Jan 2014 - Mar 2020New York, New York, UsProvides support to the VP of Quality by leading Manufacturing Quality, Quality Investigations, Quality Services, and Batch Release functions across all business units.• Member of the Site Leadership Team.• Manage four quality departments consisting of 160 employees. • Accountable for manufacturing’s compliance to global cGMP requirements and final product dispositioning.• Provide quality expertise and oversight in high risk investigations ensuring root cause identification and appropriate CAPA development.• Manage Investigation compliance through metrics and audits.• Ensures appropriate quality oversight throughout the manufacturing process including on the floor auditing and real time batch record review. • Quality Operations representative for all new products, equipment, and facility upgrades. -
Remediation DirectorPfizer May 2012 - Jan 2014New York, New York, UsResponsible for the identification of gaps and remediation activities within quality and manufacturing business units ensuring compliance to cGMPs and other industry regulations.• Developed, prioritized, and managed a master list of initiatives to ensure compliance and continuous improvement throughout the site.• Developed a Remediation Long Range Plan used as a planning tool to drive quality system improvements aligned with industry expectations.• Completed gap and risk assessments across quality systems and implemented corrective actions to remediate gaps.• Led Inspection Readiness activities including SME training, mock inspections, prep and strategy process design.• Facilitated Inspection Strategy through several regulatory inspections including; FDA, Health Canada, TGA, FDA Device
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Cold Chain Project Manager, PrincipalGenzyme Jul 2010 - Apr 2012Paris, France, FrResponsible for managing all aspects of global cold chain distribution projects from inception through completion. Lead teams in developing project plans, budgets, timetables, tasks, and communication processes.• Project leader for the development of thermal shipping systems used to ship samples, bulk raw materials, bulk product, and finished products globally• Change control sponsor for all multi-site cold chain initiatives• Leader of global initiative to create regional ambient temperature profiles use for the development of thermal shipping systems• Distribution representative on team responsible for the successful implementation of an external database used to maintain data retrieved from temperature recording devices during transportation of Cold Chain products -
Director, Lean ImplementationAstrazeneca Feb 2006 - Aug 2009Cambridge, Cambridgeshire, GbCreated and implemented new processes aligning site’s supply capabilities with demand requirements. Acted as liaison between supply site and US headquarters ensuring the integration of an end-to-end supply chain process.• Member of Lean Mobilization team defining strategic vision, lean program, and launch requirements• Participated in the development and implementation of a process centric organization aligning all aspects of an integrated supply chain• Created product line designs minimizing use of shared assets focusing on capacity, demand, and flow• Successfully implemented value stream mapping opportunities within manufacturing, warehouse functions, and supply chain• Determined appropriate Inventory Replenishment Levels and process for routine review• Created analytical tools for integrating events, planned and unplanned, within a manufacturing sequence to ensure minimal impactACCOMPLISHMENTS:- Site selected as sole source supplier for billion dollar product- Achieved 20% reduction in work force through implementation of new ways of operating- Reallocation of work to create asset loading of 80% or less (most lines) -
Site Project Director, Demand Driven SupplyAstrazeneca Jan 2005 - Feb 2006Cambridge, Cambridgeshire, GbEstablished platform for site wide lean initiative by leading 3 cross-functional project teams charged with reducing cycle time of 142 products, compounding through shipment. • Created, implemented, and trained site (600 employees, all levels) on Demand Driven Supply • Defined location and size of all in-process kanbans• Created visuals to ensure flow of all 142 products across shared assets• Standardized metric data collection and analysis, focusing on cycle time reduction• Provided monthly process updates to site and global leadership• Coordinated change management and site communications for all aspects of the projectsACCOMPLISHMENTS:- Established platform for site wide lean initiative - 37% cycle time reduction on all site manufactured products- $3.16M in inventory savings- 82% reduction in documentation review time - Freed up warehouse capacity by 35%
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Manufacturing Director, Solution & Component PreparationAstrazeneca Aug 2001 - Jan 2005Cambridge, Cambridgeshire, GbManaged 50 people within two departments, across three shifts responsible for the preparation of bulk solutions and the processing of primary sterile components and equipment for aseptic filling.• Provided leadership and strategic direction focusing on quality improvements and waste reduction • Successfully transferred solution preparation processes including lyophilization cycle and sterile component processing for commercial scale up of new products • Led project team in the reformulation of 4 products while ensuring minimal impact to supply• Led Aseptic area upgrade, responsible for ensuring cGMP compliance during major structural changes to filling suites and surrounding classified areas• Managed all budgets ($3M annually) and capital expenditures for the department•SAP Single Point of Contact responsible for providing assistance during SAP Implementation to all manufacturing personnelACCOMPLISHMENTS:- Instituted training program resulting in a 70% decrease in rejected batches in the formulation department (2003 vs. 2004)- > 96% of solutions prepared delivered on time to Filling (consistently)
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Manufacturing Supervisor, Solution PreparationAstrazeneca Jun 1998 - Aug 2001Cambridge, Cambridgeshire, GbSupervised 12 direct reports responsible for the preparation of parenteral and topical products as well as all associated validation and cGMP requirements.• Led new product scale up activities – formulation review, creation of technical documentation including batch records and SOPs, execution and validation• Developed capital proposals for new equipment necessary for process enhancements, including sourcing options and validation requirements• Maintained metrics and performed monthly safety audits
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Quality Assurance Supervisor, In-Process MonitoringAstrazeneca Feb 1995 - Jun 1998Cambridge, Cambridgeshire, GbSupervised ~20 quality inspectors across three shifts responsible for monitoring manufacturing processes to ensure compliance of all SOPs and cGMP requirements. • Assessed impact and created corrective action plans for in-process quality issues throughout the manufacturing process• Responsible for conducting and documenting quality investigations • Developed and implemented new systems to increase department productivity
Rita Boucher Skills
Gmp
Quality Assurance
Fda
Cross Functional Team Leadership
Six Sigma
Capa
Change Control
Validation
Pharmaceutical Industry
Sop
Continuous Improvement
Lean Manufacturing
Quality System
Process Improvement
Manufacturing
21 Cfr Part 11
Gxp
Leadership
Management
Quality Control
Supply Chain
Change Management
Strategy
V&v
Sap Products
Kaizen
Software Documentation
Project Management
Supply Chain Management
5s
Training
Analysis
Product Development
Value Stream Mapping
Sap
Integration
Computer System Validation
Rita Boucher Education Details
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Assumption CollegeBiology -
Quality & Productivity Solutions, IncLean
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University Of HartfordSecondary Education
Frequently Asked Questions about Rita Boucher
What company does Rita Boucher work for?
Rita Boucher works for Sharp Services
What is Rita Boucher's role at the current company?
Rita Boucher's current role is Quality pharmaceutical professional | 30 years in industry | Aseptic processing and TS operations | Sterile injectables | cGMP | Continuous Improvement | CDMO Experience.
What is Rita Boucher's email address?
Rita Boucher's email address is ri****@****ira.com
What schools did Rita Boucher attend?
Rita Boucher attended Assumption College, Quality & Productivity Solutions, Inc, University Of Hartford.
What skills is Rita Boucher known for?
Rita Boucher has skills like Gmp, Quality Assurance, Fda, Cross Functional Team Leadership, Six Sigma, Capa, Change Control, Validation, Pharmaceutical Industry, Sop, Continuous Improvement, Lean Manufacturing.
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