Quality Customer Service

Mark Hallett

Email: *********@********.***

Address: *** ***** *****

City: Lynchburg

State: VA

Zip: 24503

Country: USA

Phone: 203-***-****

Skill Level: Director

Salary Range: $175,000

Primary Skills/Experience:

See Resume

Educational Background:

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Job History / Details:

MARK D. HALLETT

CAREER SUMMARY

A HIGHLY-EFFECTIVE, RESULTS-DRIVEN LEADER who consistently delivers superior results. Demonstrated success engineering and leading high-impact optimization initiatives in Manufacturing Operations and Regulated Quality for small to multi-billion dollar companies worldwide. Expertise in Global Manufacturing, Quality Systems engineering, and cGMP regulatory compliance. Proven ability to develop and deploy strategic and tactical business plans, and lead diverse high-performance work teams by creating a common focus. Skilled at project planning and execution, organization development, team mentoring, and creative problem solving.

KEY QUALIFICATIONS

*Operational Excellence & Continuous Improvement *GMP / QSR Regulatory Compliance, CAPA *Multi-Functional Matrix Team Leadership

*Lean Process Transformations & Process Re-Engineering *Process & Product Optimizations & Validations *Supply Chain, ERP Systems & Techniques

*Six Sigma-Based Quality Systems Engineering * Performance Management

& Cost Containment *Financial Turnarounds & Acquisition Integrations

PROFESSIONAL EXPERIENCE

Accupac, Inc., Lakewood, NJ 2011 - 2013

Accupac manufactures and packages OTC and Rx liquids, creams, lotions, pastes, ointments, and gels into bottles, tubes, jars, and syringes for the world`s largest pharmaceutical and consumer products companies.

GENERAL MANAGER, LAKEWOOD OPERATIONS

Responsible for executing Accupac`s rapid growth and business continuity strategies by commissioning and starting up a 218,000 ft FDA-regulated facility with a production capacity of 200 million units annually, and for obtaining client approvals and sales orders for the facility.

*Retrofitted an existing pharmaceutical production site to exceed GMP regulatory and client expectations.

*Recruited an experienced, high-performing management team and workforce from within the industry.

*Developed and implemented GMP Quality Systems. Validated infrastructure systems, production equipment, and product-specific processes.

*Obtained facility approvals and production orders from ten clients, totaling 40 million units annually, by successfully batching and packaging validation, stability, and commercial production batches.

KDC/Tri Tech Laboratories, Inc., Lynchburg, VA 2009 - 2011

Tri Tech Labs, a $750mm division of KDC, is an FDA-registered, full-service, custom manufacturer of OTC health and beauty products and cosmetics serving multi-national Fortune listed clients. Personal care products include liquid soaps, creams, lotions, shower gels, body washes, shampoos and conditioners. Topical OTC drug products include antibacterial hand sanitizers, sunscreens, and anti-acne products.

SENIOR DIRECTOR, QUALITY & PROCESS OPERATIONS

Responsible for strengthening the Quality Systems and Quality organizations to support double-digit growth while assuring exceptional levels of regulatory compliance and client satisfaction.

*Reorganized and re-capitalized the Quality organization to meet current pharmaceutical standards and FDA`s Quality System Regulations. Recruited a first-tier Quality/Regulatory organization.

*Doubled batch throughput in Dispensing, Compounding, and QC Lab while reducing headcount by 28%.

*Established facility-wide KPI metrics and CAPA to drive cost reductions and continuous improvement.

Compass Pharmaceutical, Clifton, NJ 2008 - 2009

Compass is an FDA-regulated contract packager of solid dose Rx, OTC, and nutraceutical powders, tablets, and capsules into pouches, hospital unit dose and multi-dose blister packs, re-sealable cans, and bottles.

GENERAL MANAGER

Responsible for leading this 200 person unionized acquisition out of bankruptcy to profitable operation.

*Raised production throughput by 40% utilizing Operational Excellence/LEAN Six techniques, negotiating beneficial union work rules, partnering with suppliers, and re-engineering and re-validating processes. Reduced overtime from 15% to 2.5%, eliminating the temporary labor force.

*Improved on-time shipments from 45% to 100% by implementing ERP techniques, creating a customer-oriented focus company-wide, and restructuring the Logistics organization.

*Increased equipment reliability by deploying $1.3 million in capital equipment, implementing preventive & predictive maintenance, and in-lining secondary pack out operations.

*Reduced batch release time 64% by transitioning to a LEAN Batch Record format. Achieved zero customer complaints. Brought facility to full GMP compliance with no FDA 483`s from two inspections.

Outsourcing Services Group, Inc., Woodcliff Lake, NJ 2004 - 2008

OSG was a nine division contract manufacturer/packager of personal care, color cosmetics, OTC and prescription drug products. Acupac Packaging manufactures unit dose packettes, dry coated stacked towelettes, and thin-film RX, OTC, and personal care products utilizing a patented cutting-edge delivery system. Piedmont Laboratories manufactures aerosol OTC, personal care, and cosmetic products.

CORPORATE DIRECTOR, QUALITY and OPERATIONS

Responsible for preparing business units for spin off by strengthening Quality Systems to comply with FDA`s Quality System Regulations, resolving open FDA 483`s, and restoring profitability in each division.

OSG/Piedmont Laboratories

*Engineered and executed a $9 million operational turnaround on sales of $75 million by implementing LEAN Six and ERP scheduling techniques. Doubled line outputs while reducing line crew size by 33-70% without capital investment. Eliminated customer backorders.

*Achieved full GMP compliance by implementing FDA 483 corrective actions. Earned key client Quality certifications. Restructured and led the Laboratory and Quality Assurance organizations. Successfully transitioned Quality inspection activities, systems, and people to Production.

*Developed a divestiture plan; Successfully transitioned the two-plant aerosol division to new ownership.

OSG/Acupac Packaging

*Led a $5 million turnaround on sales of $23 million by reducing the cost of goods manufactured by 42%. Achieved record profit-contribution levels by implementing ERP scheduling and Lean Six Sigma practices and high-performance work teams in this unionized 250 person division.

*Prepared a technology-focused strategic plan for the division that included major product line relocations, site acquisition, construction, validation, and commissioning.

*Achieved full GMP and SHE compliance by implementing 820 Quality Systems, validations, self-improvement auditing, and employee education programs. Successfully resolved FDA 483`s and customer issues while reducing cost of quality by 33%. Prepared a site Validation Master Plan, conducted validations for major process systems, and re-established in-house analytical laboratory capability. Acted as U.S. liaison to FDA for OSG`s Canadian subsidiaries, and to foreign regulatory organizations and Notified Bodies. Restructured the QMS and re-wrote all SOP`s. Re-structured the QA, Document Control, Records & Release organizations, and established a Materials Quality Review Board.

*Led a company-wide, multi-national Quality Leadership Team to establish QSR, ISO, CAPA, and Lean Six tools throughout OSG. Provided regulatory leadership and support to seven OSG sister divisions.

Riverside Capital / ATC Distribution Group, Inc., Ontario, CA 2001 - 2004

Riverside is a multi-national private equity investment firm that acquires mid-sized, industry-leading companies. Aftermarket Technology Corp (ATC), comprised of five automotive aftermarket companies, remanufactures transmissions and hard parts for passenger, industrial, and military vehicles worldwide.

VICE PRESIDENT, MANUFACTURING

Responsible for integrating three acquired manufacturing companies to establish a single ATC Remanufacturing Division. Managed three plants and staffs with a total of 600 direct labor employees in Pittsburgh, Los Angeles, and Mexicali, Mexico. Led high-performance optimization initiatives to improve product quality, customer service, and shareholder equity. Had full P&L responsibility for the Remanufacturing Division.

*Engineered and executed a $12 million turnaround on sales of $100 million by leading LEAN Six implementations, reengineering production processes, and managing the supply chain. Minimized the cost of goods by 34% and managed down field failures by 80%, driving up sales revenue 27%.

*Improved service levels by 26%, inventory accuracy to 99.97%, and doubled inventory turns.

*Generated $7 million in incremental revenue by designing and constructing a 12,000 ft plant for remanufacturing a new transmission product line for the USPS. Obtained capital, equipment, and successfully launched the product in four months, achieving a sustained zero-defect level.

The Hartz Mountain Corp., Secaucus, NJ 1998 - 2001

Hartz Mountain is the world`s leading manufacturer and distributor of quality products for companion animals including health and beauty chemicals, OTC pharmaceuticals, and superior-quality food products it manufactures in owned and contract facilities in the U.S., Canada, Denmark, Brazil, and the Orient.

VICE PRESIDENT GLOBAL QUALITY & COMPLIANCE

Established a Quality orientation throughout the organization to drive continuous improvements in product quality and GMP compliance. Deployed an 820 Quality System architecture, organizations, and practices in FDA-regulated plants worldwide. Liaison to U.S. and foreign regulatory organizations and Notified Bodies.

*Established Quality organizations, systems, and practices from start-up in nine plants. Developed internal, supplier, and customer auditing programs. Achieved -Superior- AIB hygiene ratings in all plants.

*Formed and led a product launch team that achieved FDA approval for an OTC product line. Conducted qualification trials, validated new plant and equipment, developed SOP`s, and established cGMP/HACCP practices. Product generated $15 million in annual sales. Promoted from Director to Vice President.

*Facilitated high-performance, multi-national, cross-functional work teams to design, construct, and validate sanitary-design/HACCP approved food plants in the U.S. (2), Brazil, and Denmark.

Schein Pharmaceutical, Carmel, NY 1994 - 1998

Schein (now Watson) is a multi-billion dollar manufacturer of multi-source oral solid dose prescription drugs.

DIRECTOR, PROCESS RE-ENGINEERING

Led business-excellence initiatives in Quality/Laboratory Services, Supply Chain, and Manufacturing to assure regulatory compliance, optimize customer service, and improve bottom-line financial performance.

*Prepared and executed an FDA 483 remediation plan for the Quality Laboratory that re-established GLP and GMP compliance by putting into practice an FDA/DEA-accepted drug control system.

*Saved $4 million in year-over-year laboratory costs. Doubled throughput of samples and brought outside testing in-house. Reorganized, merged lab operations. Implemented systematic scheduling techniques and supplies purchasing controls. Re-capitalized the HPLC, GC, and Dissolution lab work centers.

*Eliminated $1.2 million in backorders. Reduced total material conversion cycle time 33% by sourcing and implementing upgraded ERP scheduling and forecasting software (BPCS II/Demand Solutions). Developed, initiated, and facilitated a Corporate/Division Sales & Operations Planning process.

*Led a cross-functional batch size scale-up work team that saved $8 million in direct and indirect costs.

*Facilitated a cross-functional team of Directors to re-write 800+ Standard Operating Procedures to remediate GMP compliance issues observed within their operational areas of responsibility.

Pendaflex North America, Garden City, NY 1989 - 1994

Pendaflex is a division of Esselte AB, a $4.5 billion international conglomerate. Pendaflex manufactures and distributes office products, equipment, and furniture it produces in plants throughout North America.

CORPORATE DIRECTOR, NORTH AMERICAN OPERATIONS & QUALITY

Developed and deployed tactical and strategic initiatives to improve operating and financial performance in operations in the U.S., Canada, and Mexico. Established Quality organizations from start-up in ten plants.

*Planned, designed, and executed a $20 million technology-focused rationalization strategy saving $13 million annually by reducing manufacturing and distribution facilities 53%, with no loss in service level.

*Generated $32 million in labor and related savings over four years by leading company-wide performance optimization initiatives across the plant network. Improved productivity 44% by implementing SMED, TPM, Continuous Improvement, and other LEAN Six Sigma toolbox techniques.

The Kaelin Group, Bridgeton, NJ 1978 - 1989

The Kaelin Group is a management consulting firm that designs and implements business process improvements and cost containment systems for a diverse international client base, specializing in the pharmaceutical, medical device, OTC consumer products, and other FDA-regulated industries.

VICE PRESIDENT of OPERATIONS & BUSINESS ANALYSIS

As the first employee of this start-up management consultancy, led 150 successful client engagements, directing 50 Business Analysts engaged throughout the US, Mexico, Canada, and Puerto Rico.

*Managed client program design and implementations, client relations and business development, and profit contribution. Held positions of increasing responsibility from Staff Consultant to Engagement Leader to Operations Director to Vice President.

*Improved profitability in clients` pharmaceutical, medical device, consumer product, and other FDA-regulated operations by applying LEAN Six Sigma, cellular, SPC, SMED, continuous improvement, TQM, activity-based accounting, and other innovative management techniques to solve the unique operating situations of each client.

EDUCATION

Bachelor Degree, University of Rhode Island, Kingston, RI

CERTIFICATIONS & SPECIALIZED KNOWLEDGE

Productivity Optimization, Continuous Improvement, Complaint Management and CAPA Systems, Statistical Process Control, Activity Based Costing, Lean Six Sigma, SMED, TPM, APICS MRP/ERP, Transactional Analysis, New Product Introduction, cGMP Auditing, HACCP/Product Safety, Process Validation, Clinical Microbiology, Purified Water System validation.

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