Quality System Consultant

CORE COMPETENCIES

EXPERIENCE

Independent Quality System Consultant 2010 – Present

Source resources and managed a team ranging from 4 to 36 consultants for various med device, biotech and pharma clients:

• Resources included both long term embedded employees acting on client’s behalf as well as short term project specific consultants such as auditing/gap analysis, risk analysis, regulatory submissions.
• Developed project objectives, goals and timelines to bring quality system elements up to regulatory standards.
• Report project status to client sponsor and update executive management team
• Made recommendations to client on resource needs and allocation
• Successfully hosted or participated in various regulatory audits on client’s behalf Managed quality system remediation and interim controls projects at various medical device and pharmaceutical companies that:
• Audited the site’s various quality systems. Developed reports and presented findings to the client
• Developed remediation plans based on the client’s current capabilities such as existing IT, headcount and organization structure and presented the plans to the client for approval.
• Developed, retired or revised SOPs to support the new quality system requirements.
• Developed training materials and curricula and presented to the client’s SMEs and system owners Authored or edited and presented the following documents to the client throughout all phases of the remediation process:
• Protocols detailing the activities and required deliverables throughout all phases of the internal investigation and remediation process
• Final reports to close out the execution of individual protocols
• Position papers on various key issues that were discovered during the internal investigation in preparation for a regulatory audit
• Developed and presented project updates to the client’s senior management steering committee every 2 weeks throughout the project life cycle
• Performed headcount evaluations and project budgeting and presented proposals to the client’s finance department

Directed multiple audits under the mandate of a consent decree at global aseptic processing and pharmaceutical and medical device facilities. Areas audited include all quality systems, production, storage areas, data integrity and process validation.

Performed Global GMP audits and gap analysis of equipment, facilities and quality systems within the Vaccine & Diagnostic, Pharmaceutical, and Medical Device industries against FDA and EMA regulations and industry standards;

• Assessed internal documentation and requirements
• Audited equipment, processes, data integrity, facilities and utilities
• Audited actual practice against internal documented requirements and industry standards
• Delivered gap assessments to the client as issues and recommendations were observed
• Developed and delivered final reports to the client
• Reviewed and approved CAPA’s that were developed in response to audit findings

NormaTec Industries, Newton Center, MA 2007 – 2010

Director of Manufacturing and Regulatory Affairs

Strategically manage all aspects of the company’s contract manufacturing operations, quality assurance, regulatory affairs and supply chain execution; oversee all contract manufacturers including identifying, auditing, and qualifying new CMO’s. Work directly with engineering on all aspects of design changes that include sourcing, validation and test requirements. Responsible for quality systems regulations;

• Developed quality metrics to track performance in customer service and quality such as CAPA closure time, CAPA effectiveness, customer complaint trending, etc.
• Significantly reduced product costs by negotiating contracts with new CMOs and securing new manufacturing agreements.
• Monitor all aspects of product quality and yields to drive quality improvements using DMAIIC methodology.
• Ensure companywide 21 CFR part 820 compliance and UL 60601-1, CSA and CE certifications
• Expanded on NormaTec’s 3 biggest contract manufacturers by dual sourcing to ensure business continuity.
• Fully manage all aspects of the CMO programs and contracts negotiations.
• Streamlined Quality System processes including Supply Chain, R/I, Shipping, Product Testing, and Product Complaints.
• Led Quality Improvement initiatives and presented information to executive management.
• Manage the handling of the customer complaint department including the initiation and tracking of all corrective and preventative actions resulting from product quality complaints.

Cordis Corporation (Johnson & Johnson) Miami Lakes, FL 2000 – 2007

Manufacturing Manager: Drug Eluting and Delivery Devices (Combination Products)

Held positions of increasing responsibilities;

Oversaw all aspects of manufacturing processes and operations of combination products while ensuring compliance with Company and Regulatory requirements including 21 CFR Part 820, 210, 211;

• Managed up to 70 direct reports and 122 indirect reports in various functions; Responsible for resource allocation and utilization, setting goals that spanned across other functional groups, and tactical execution of global strategies;
• Oversaw completion and approval of Deviations and CAPA’s that spanned sites in Miami, Mexico, Puerto Rico and the Netherlands using TrackWise quality management software.
• Developed the strategy and implemented Lean tools and concepts globally to improve cross site communication and reduce waste and reduce Deviation and CAPA closure time.
• Strategically set department and individual goals to align with organizational direction
• Implemented Lean on several lines throughout the plant, including extrusion line, Final Assembly and other production lines
• Achieved high department performance by training, mentoring and coaching employees on the principles and work flow in the Lean manufacturing lines.
• Led the team responsible for the start up of the returned goods re-box production area to salvage product returned by the customer and distribution center using Six Sigma techniques. Coordinated with IM, QA and Final Release to setup new Re-box production area including written procedures and electronic transactions and traceability.
• Led a team to develop and implement the dimensional inspection procedures and visual standards in air extrusion area including Test Method Validations and equipment qualifications.
• Green Belt Certified. Black Belt and Lean trained.

Kimberly-Clark Corporation, San Antonio, TX 1996 – 2000

Production Project Leader

Managed a cross-functional team to develop a new product line which included purchasing and installation of equipment, development of operating procedures, manufacturing of pilot batches for shelf life tests and capacity planning

• Led the replacement of a manual filling system with a computerized control system for the bulk pharmaceutical manufacturing area.
• Oversaw the microbiological culture area for product challenges and testing.
• Responsible for 50 direct reports in the bulk manufacturing, aseptic filling and packaging of pharmaceuticals with API’s across all production lines in a FDA regulated facility. Managed performance and development of operations personnel.
• Facilitated program to get all employees cGMP certified for FDA compliance
• Developed and obtained approval for a project budget of $1.7 MM. Managed the budget throughout the duration of the project. Worked on acquiring permitting with numerous agencies such as OSHA, TNRCC, ATF, etc.
• Reduced manufacturing wastes from 6% to 3.25% through waste recycle and process improvements.
• Reduced the disposal of off-specification product by 40%.
• Initiated and wrote capital expenditure proposals for process improvements across all packaging lines to improve overall packaging efficiency, machine up time and batch times.
• Managed several project budgets ranging from $75,000 to $1.7MM

EDUCATION

MBA - Florida International University

• Master in Business Administration: Executive Program.

Bachelor of Science Degree - Texas A & M University

• Major in Chemical Engineering