Quality Assurance Project Manager

Artemio Villasis

Email: abpwb7@r.postjobfree.com

Address: *** ********* **** ***# *

City: King of Prussia

State: PA

Zip: 19406

Country: USA

Phone: 610-***-****

Skill Level: Management

Salary Range: $150,000

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

See Resume

Job History / Details:

Artemio -Bobby- Villasis 210 Clubhouse Road Apt# F King of Prussia, PA 19406

610-***-**** (cell)

abpwb7@r.postjobfree.com

Pharmaceuticals Biotechnology

PROJECT MANAGEMENT (TECHNOLOGY TRANSFER) OR QUALITY ASSURANCE

Strategic Planning Process Development & Validation Lean Manufacturing Six Sigma Kaizen ISO 9000 cGMP Cost Reduction Audit Regulatory Filing Project Engineering FMEA DOE Compliance Technology Transfer Quality Assurance Strategic Outsourcing (APIs) Project Management CMC External Manufacturing Quality Systems New Product Life Cycle Management

Dynamic and self-driven leader with MBA in production & operations management and 10+ years of experience in technology transfer, process optimization, compliance, cost control, quality assurance, and pharmaceutical manufacturing for employers including pharmaceutical leaders, McNeil Consumer Healthcare, Teva and Wyeth. Astute analyst, strategic thinker and problem solver. Excellent communicator; foster productive working relationships across diverse disciplines and organizations. Superbly talented manager, orchestrated multiple, simultaneous and complex initiatives that unfailingly achieved technical objectives, budgets and sensitive business timelines.

CAREER TRACK

ASSOCIATE DIRECTOR: External Manufacturing Quality OCT 2010 - Present

MCNEIL CONSUMER HEALTHCARE Fort Washington, Pennsylvania

Lead all business interactions and drive all decisions with external manufacturing partners relating to product quality assurance and quality controls for McNeil Consumer Healthcare Division of McNeil-PPC, which markets a broad range of over-the-counter products. Manage the External Manufacturing Quality Account function to assure compliance with applicable regulations for External Manufacturers (EM) and delivery of a quality product. Lead a group of Quality Account Managers and Engineers who are responsible to ensure both ongoing quality product manufacturing and testing as well as new product launches from EM sites. Monitor new regulatory legislation or guidelines which have direct impact on the business in relation to managing contractors.

Ensure the execution of McNeil Quality Standards, timely and compliant identification and resolution of Product Quality issues and timely identification and resolution of GMP compliance issues

Manage and coordinate External Manufacturing Quality Assurance activities on new projects, product transfers, and improvement teams by guiding technology transfer decisions, setting project quality/ compliance requirements, and providing technical transfer/validation support for base business and new product commercialization.

Provide a system for consultation, advisement, and assistance for site activity support and review, approve, respond, and follow-up to auditing reports systematically.

Provide Quality Assurance oversight to Business Continuity Plan (BCP) actions for compliant recovery of Fort Washington facility.

Participate in the development & implementation of Quality Systems elements in support of the Consent Decree work plan requirements.

Started as Principal Quality Engineer and later promoted to Associate Director of EM Quality.

PROJECT MANAGER: Technical Operations 2004 - Sept 2010

TEVA PHARMACEUTICALS North Wales, Pennsylvania

Delivered project management expertise vital to achieve optimal manufacturing quality standards for a Top 20 global manufacturer of generic and branded pharmaceuticals with $16 billion in annual sales. Conducted detailed evaluations of proposed projects; quantified return-on-investment (ROI) and efficiency gains. Developed strategic objectives, schedules, and milestones for process improvement, compliance and

Artemio Villasis Page 2

Technology Transfer initiatives. Led projects from inception through commercial launch; facilitated team communications; troubleshot problems, monitored and reported results.

Managed, coordinated, and drove implementation for the global & domestic technology transfer of manufacturing processes and analytical test methods for 30+ new and existing products of various dosage forms between development and operation groups, as well as 40+ alternate API source qualification projects, including third parties (CMO) when necessary.

Generated significant results in process improvement and cost reduction; directed projects to achieve highest possible levels of efficiency.

TEAM LEADER: Sustainable Compliance Initiative (SCI) 2001 - 2004

WYETH PHARMACEUTICALS West Chester, Pennsylvania

Spearheaded compliance directives and project engineering initiatives governing the manufacturing of ESI Lederle injectable penicillin products for this global leader in pharmaceuticals products. Led SCI teams in assessing, planning, designing, implementation and verification of the plant`s Level III standard operating procedures and systems, to ensure cGMP compliance with standards for parenteral drug manufacturing. Defined requirements and created action plans. Led cross-functional teams that included Operations, Technical Services, Engineering personnel and outside consultants.

Designed and instituted a plant-wide sustainable compliance program; implemented corporate standards, consent decree commitments and resolved FDA 483 issues to meet all deadlines.

Enacted process engineering improvements in formulation and crystalline areas of operation. Reviewed and wrote manufacturing investigation reports (MIRs).

Provided project leadership to global, cross-functional team(s) in the successful integration of best practices into all sites within the pharma operating unit. Organized global teams responsible for developing the best practices, and subsequent rollout to various sites.

QUALITY CONTROL SUPERVISOR 1998 - 2001

DANA CORPORATION / SPICER DIVISION Lancaster, Pennsylvania

Developed and implemented the overall torque control program for the modular chassis assembly of Mack trucks; prepared annual capital expenditure for this program. Developed and drove quality plans and led special initiatives. Directed a team of three (3) responsible for managing torque equipment maintenance, repair and calibration. Conducted machine and process capability studies; analyzed process deviations. Assisted quality auditors and corrected manufacturing deviations.

Headed capital projects; worked with vendors to develop enhancements for process equipment; installed a statistical process control system and provided user training.

Improved quality results by leveraging techniques and tools that included Failure Mode and Effects Analysis (FMEA), statistical process control (SPC) and periodic capability studies.

ENGINEERING MANAGEMENT 1996 - 1998

NORTH STAR STEEL Monroe, Michigan

Served in a leadership development training role in various capacities for this company manufacturing special bar-quality steel for an automotive supplier with 350 workers.

Coordinated raw materials transport, melt shop, rolling operations to ISO 9000 quality standards.

Assisted in managing production, with other duties including conducting first party audits to ensure ISO-9001 system compliance.

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Previous positions include:

Warehouse Supervisor - Mannai Trading Company

Sales Engineer - Cummins Diesel Engine Sales & Service

LEARNING CREDENTIALS

MASTER OF BUSINESS ADMINISTRATION: Production & Operations Management, GPA 3.8

Drexel University, Philadelphia, Pennsylvania

BACHELOR OF SCIENCE: Mechanical Engineering

University of the Philippines, Quezon City, Philippines

Additional courses, seminars and workshops include:

Technology Transfer for Pharmaceutical & Biotech Industries Implementing Key Requirements for Validation Manufacturing Investigation Report Writing Internal Auditor course Statistical Process Control Failure Mode & Effect Analysis (FMEA) Taguchi Six Sigma Black Belt Negotiation Skills for Project Managers

CERTIFICATES & LICENSES

Project Management Institute - Certified Project Management Professional (PMP)

American Society of Quality - Certified Quality Engineer

Certification for Six Sigma Black Belt (in-progress)

ORGANIZATIONS & ASSOCIATIONS

International Society for Pharmaceutical Engineering

American Society for Quality

SOFTWARE PROFICIENCIES

Microsoft Office: Word / Excel / Access / Project / PowerPoint / Visio

SAP/ ETQ/ TrackWise Quality Management

REFERENCES AND FURTHER DATA PROVIDED UPON

ESTABLISHMENT OF MUTUAL INTEREST

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