SUMMARY

I am a Quality executive with 18 years of successful experience leading operations and customer service in QA/QC and Regulatory Compliance within mid-size and large corporations. Successful in generating significant cost savings, reorganization, standardizing, and streamlining process, policies, and procedures to maximize customer service performance and quality across laboratory and manufacturing operations. Highly effective at building and directing cross-functional teams to design and display corporate wide, compliant quality systems and performance driven products, as well as achieving ISO certifications. Excel at diversifying and executing compliance tools and business solutions to deliver increased quality, productivity and right first time programs. Exceptional skills in process, customer service assessments, key performance measurements and customer service resolution. Provide capabilities in building comprehensive quality management programs in accordance with ICH guidelines. I am very experienced in API/Drug Product and extensive management experience with a progressive approach to fostering an environment of continuous improvement while ensuring regulatory compliance.

CORE LEADERSHIP COMPETENCIES

• QA/QC/CMC Regulatory Compliance CMC, NDA, ICH, FDA cGMP, cGLP, cGXP, GCP,
• Quality Audits/FDA Inspections Raw Materials/API's ISO 9001, ISO 17025, ISO 14001
• 21 CFR Parts 210, 211 TrackWise/Documentum CAPA/OMS Team Leadership Collaboration
• Performance Management Project Management OSHA/EPA/Safety Compliance
• Customer Service/Relations Manufacturing Investigations LIMS Development
• Six-Sigma Programs Lean Manufacturing Continuous Process Improvement

PROFESSIONAL EXPERIENCE

Confidential

DIRECTOR

• Lead the development, implementation and maintenance of the company's quality and regulatory compliance management systems across multiple US sites to ensure compliance with Good Manufacturing Practices GMP , regulatory agencies and corporate expectations.
• Contribute to the setting and evaluation of the business strategies and objectives
• Lead the development of the business's quality and regulatory compliance vision
• Develop, implement and evaluate departmental resource QA, RA and QC and operational strategies in alignment with business objectives and capacity
• Manage departmental financial budgets capital, expense, resources
• Lead customer and government regulatory agency audits - FDA, MHRA, KFDA, ANVISA, EMEA, EU, PMDA, TFDA to DATE
• Provide leadership in departmental human resources management in collaboration with the department managers e.g. recruitment, performance management, training and career development, interdepartmental communications
• Provide leadership and guidance on taking quality decisions poised with the business requirements in times of need.
• Lead in the development and delivery of business wide staff quality training
• Approve critical quality or regulatory policies, procedures, agreements, reports and annual reviews
• Act as a designate for the managers during his/her absence for the purposes of approval on documents such as state licenses or release of product.
• Establish and maintain linkages with external resources in industry and government regulatory agencies
• Liase with corporate functions in the development and implementation of quality and regulatory compliance initiatives
• Ensure execution of quality management systems and sustenance of compliance as per regulatory expectations.
• Provide direction and guidance in streamlining QC function with regard to method development, instrument qualifications and procurement, analytical validations, QC layout and men/material flow, cost reduction in QC functions, effectiveness of analytical functions by optimizing sampling and testing.
• Promote the company's established safety policies, procedures and programs.

Confidential

ASSOCIATE DIRECTOR

• Ensure cGMP and regulatory compliance with all FDA and applicable external US regulatory requirements and guidance documents within Aptalis and its vendors.
• Direct and manage all FDA and other regulatory agency activities including inspections, inquiries, notifications and other agency associated activities.
• Hosted PAI Inspection and General Inspection from FDA Cincinnati, OH District.
• Direct and ensure all Aptalis Quality Systems are managed and continuously reviewed and improved for regulatory compliance and operating efficiencies.
• Coordinate customer and regulatory audits of Aptalis Operations Group .
• Designed, developed and implemented cGMP and other relevant Quality System training programs for Aptalis employees with coordination of site training manager.
• Approve all documentation used in relation to production of product and its related activities validation, quality, control testing, release, stability, engineering, etc. .
• Lead the personnel in accordance with Aptalis philosophies to include performance appraisals, training and development programs, team building, etc.
• Actively participated in the management of Aptalis and the development and implementation of policies.
• Actively participated, with other managers, in the identification and resolution of problems related to Aptalis operation.
• Communicated and provided leadership to staff to obtain good attitude, team effort, productivity, loyalty and quality improvements.

Confidential

SR. MANAGER OF QA then promoted to above

• Manage 9 Direct Reports within Quality Unit/ 400 quality employees responsible for including: QA Release, Stability, Document Control, QA Operations, QAE's, Supplier Quality Management and Contract Quality Sales Professionals .
• Responsible for reviewing and approving documents generated from Deviations, Annual Product Reviews, Standards Operating Procedures, Laboratory Investigation Reports OOS OOT's and Manufacturing Investigations.
• Provides risk assessment over significant Quality events.
• Work with operations, laboratory, engineering, and maintenance Directors, Managers and staff to develop, evaluate and implement action plans which maintain or improve product and process quality.
• Developed and maintained auditing and release procedures which ensure products released for shipment meet company, customer and FDA standards.
• Lead and guided others in quality driven initiatives in the continuous support of Quality Improvement. Extended Learnings, Deviation Reduction Plan and CAPA initiatives
• Supply support to PMH External Customers as it relates to Deviations, Customer Complaints and Product quality.
• Supports and Hosts FDA, customer, internal, and other regulatory audits and responses.
• Provide support on Quality Capital Projects and set timelines to meet the quality initiatives within the quality organization. Leading site for the EDMS Pilot
• Travel and Provided cross-functional support to other Perrigo quality units to incorporate quality initiatives to PMH and other satellite sites as required. VelQuest ELN, TrackWise Resources for Customer complaints
• Evaluation of finished product or packaged material for compliance with internal standards.
• Determined appropriate level of risk associated with non conformances.
• Established Quality Council and Deviation Review Board to discuss plant initiative quality events and objectives as it relates to the company goals and standards.
• Reduced Total Turn-around-time TAT for finished product release of batch records by 60 which has direct release of 500K more on average a month for the site.
• Created and established PMH Quality Metrics for overview of accountability for executive staff within the organization as it relates to PMH metrics based on customer service week by week reports to show progress .
• Lead and executed the Extended Learnings for the site as it related to the warning letter to identify and observe GAPs within PMH quality systems.
• Restructured Quality Unit Staff to better utilize capabilities and reduction of overall Overtime within the department by 20 .
• Lead and Restructured resources to save 32K in real savings of resources and labor for construction and enhance QA retrieve ability of documents and retains for audit inspection readiness.

Confidential

DIRECTOR OF QA/QC REGULATORY COMPLIANCE Solid Dose- Enzymes-FP

• Manage 8 Direct Reports within Quality Regulatory units 38 indirect employees 1 site analytical specialists, stability coordinators, lab supervisors, change control board, and customer complaint specialists, regulatory specialists .
• Manage, coach and develop QA professionals within the Quality unit and contribute to the growth of quality professionals.
• Reviewed CMC sections relating to NDA submissions.
• Review of quality issues related to GCP and GLP
• Set and implement appropriate quality standards and systems based upon current cGMP and company requirements across all stages of R D, manufacturing, control and distribution.
• Provide expertise on product and process quality issues.
• Provide tools and metrics to assess quality performance in relation to business objectives.
• Foster advanced QA and QC methodologies to improve quality while simplifying processes.
• Reduce process variations by 30 of all deviations being produced within manufacturing.

Confidential

QUALITY LAB MANAGER OTC/Solid Dose/Oral Dose/Injectables/Topical/Transdermals-Finals/API's

• Manage 7 Direct Reports within Quality Unit 150 indirect employees 3 facilities analytical specialists, stability coordinators, lab supervisors, change control and customer complaint specialists .
• Responsible for directing laboratory operations Analytical and Supplier QC of raw materials, packaging components, in-process, bulk and finished goods for product release. Also provided stability and product complaints in support for both production and research.
• Ensure timely analytical testing to support manufacturing operations that conform to cGMP's lab testing and safety regulations. Manage analytical testing which conforms to industry standards and current FDA requirements.
• Represent lab operations for corporate audits and FDA Inspections. Review aberrant test results, ensuring thorough investigations of all issues and determine acceptability.
• Review and approve laboratory change control and process validation studies.
• Establish and monitor laboratory operating and capital budgets. Conduct performance evaluations and devise development plans for direct reports.
• Support corporate initiatives in order to cut overhead through process improvement and quality projects.
• Developed API Vendor supplier certification program, and reduced costs of 2.2M annually from 3rd party outsourced analytical testing.

Confidential

ANALYTICAL CHEMIST Special's/Solid Dose/Oral Dose/Injectables-Finals/API's- Human Animal Health

• Review and approved critical manufacturing investigations, Lab Investigations, CAPAs and Change Controls.
• Communicate across sites for environmental services sites in support of waste stream management policies, the code of federal regulations, EPA, and OSHA guidelines.
• Managed all aspects of laboratories' individual department's on-time delivery OTD of results and operations i.e., analytical, data validation, bid reviews, and project management staff.
• Ensured compliance to financial and operational objectives i.e., OT control, consumable spending, and process improvements through lean applications.
• Controlled expenditures for personal services and supplier resources.