Quality Assurance Manager

Randall Howard

*** ********* **, ******* ** *****

Telephone: 813-***-**** (Home); 410-***-**** (Cell)

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

Professional Profile

Distiguished, technically inclined and highly empowered professional offering an eventful career of over two decades

studded with professional brilliance predominantly in the areas of quality management, technical support, and quality

operations in regulated/pharma industries. In-depth exposure to regulatory affairs, compliance, auditing, quality

assurance, quality control, CAPA, Risk Analysis and R&D in high-growth, rapid change environments. Established

performance benchmarks in directing/managing complex manufacturing and technical operations. Up-to-date

knowledge of recent amendments in the regulations stated by the authorities. Gained rich experience in Solid Dosage

Forms as well as Gels, Cream, Aerosols, Aseptic Products and other Liquids. Creative, innovative, results-driven with

immaculate work habits, excellent man-management, time management and leadership skills

Objective

Currently looking for a career opportunity that will provide a challenging avenue to significantly contribute to a

company’s efficiency, organization, growth, and profitability, and will make best use of existing skills and experience

gained whilst enabling further personal and professional development – ideally as Head – Quality Management,

Regulatory Affairs Management in a Pharma Industry

Performance Milestones

ION Labs, Inc., Clearwater, FL

• Hold the distinction of successfully leading regulatory and internally identified non-compliance remediation

efforts including Warning Letters

• Strategically initiated programs and alliances to transition culture from reactive and corrective to predictive

and preventive

• Deftly identified and led continuous improvement opportunities in non-conforming materials, processes, MRB

and complaints, supplier qualification and manufacturing first-pass yield; and implemented statistical techniques

including trend analysis

• Judiciously created supplier risk based evaluation programs, quality plans, established metrics, inspection

plans, and modified as necessary to reduce, more fully characterize products and allow flexibility for modification

with increased process knowledge

• Implemented a process oriented culture across the organization to create a baseline for achieving standard

certifications/accreditations

• Raised systems and operations to peak performance levels through creative, hands-on leadership

Formulated Solutions, LLC, Clearwater, FL

• Successfully hosted ‘483 free’ FDA inspection and all other agency inspections, and customer & partner

audits

• Earned significant client exposure and relationship development as Contract Manufacturing Liaison

• Credited for initiating management and annual review processes to ensure identification and timely resolution

of improvement opportunities including use of risk analysis

• Competently performed as regulatory liaison and FDA Management Representative; successfully negotiated

compromises in regulatory setting

• Acknowledged for having flair for efficient execution of work assignments

Sensidyne Tampa, FL

• Proactively contributed, while collaborating with senior staff, to develop Hoshin Plan, including, corporate

breakthrough strategy, key strategies and initiatives, performance metrics and oversight of deployment;

led/participated in regular progress reviews

• Eminence of being one of the six senior staff gate keepers required for determining and approving Go-Stop-

Hold project status. Authorized product innovation and product line extension roadmaps and project plan

according to a Stage Gate process

• Accredited for hosting successful FDA Medical Device, ISO 13485, ATEX, INMETRO site inspections as

well approved products and facility inspections by UL, FM, CSA, Intertek

• Set stringent quality standards and ensured strict adherence with no occasions of compromise

• Drove initiative in quality assurance domains, including all fine aspects covering – qualifications &

validations, quality audits, documentation, in-process quality assurance and chemical & instrumental analysis

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Performance Milestones contd.

Watson Laboratories, Miami, FL

• Having credential of appreciably contributing to first ever ‘483 Free’ inspection

• Proficiently managed APR process, implemented compliant procedures, and brought annual reviews in arrears

from 2000 up to date

• Adeptly reduced cycle times for testing and product release at least 50% and inspection times by up to 70%

• Contributed to the reduction of internal laboratory error by implementing SPC, and more effective training

• Recognized as a strong advocate of compliance, a good trainer and leader, and an accomplished

manager of technical resources with a proven record in building and motivating successful QA efforts

Private Compliance and Validation Consultant, FL

• Expert in development and approval of equipment and utilities qualification and validation protocols, basic

automated control systems, process, analytical methods, and cleaning (DQ, FAT, IQ, OQ, PQ, PV, CV)

Career Summary

9/2012-9/2013 Director of Quality, ION Labs, Inc., Clearwater, FL

• Shouldered the responsibility for managing the laboratory, batch review and disposition, document control,

validation, line inspection and in-coming materials inspection and CAPA

• Defined the performance standards across all functional areas and periodically reviewed performance by deft

application of concurrent management audit procedures

• Efficiently liaised with FDA District Compliance Officers and successfully presented a QPIP (Quality

Program Improvement Plan)

• Closely monitored product development and market introduction strategies from both technical and regulatory

perspectives

• Propagated Quality Circle and QbD movement and developed quality culture in the work force to achieve

quality leadership in the industry

• Collaboratively worked with operations and quality at all levels of the organization to ensure that; all

regulatory requirements were met, processes operate in a state of control and compliance and continuous

improvement is a top priority within their area of control

• Regularly ensured dependable and timely results from quality control, including process control and support

for process changes in compliance with 21 CFR Part 111 requirements

3/2009-8/2012 Director of Quality, Formulated Solutions, LLC, Clearwater, FL

• Drove the efforts to prepare for hosting, facilitating and closing out internal and external inspections/audits

and coordinated the response and corrective actions to observations

• Expertly managed resource planning to meet timelines and control costs and play interim staff roles in quality

and technical services

• Ensured that all projects and validations were in compliance with 21 CFR Part 210/211 and QSR, as

applicable

• Judiciously participated in NDA, NADA, PMA submission packages

• Meticulously monitored product quality reviews, management reviews and preparation of quality reports

• Identified shortfalls in awareness/understanding/access of process and practice while providing effective

solutions; handled incident and non-conformance reporting

• Established QbD program for all new products

11/2006-3/2009 Manager Quality Assurance and Regulatory Affairs, Sensidyne Tampa, FL

• Scrupulously planned and led efforts to improve overall compliance and resolve time critical regulatory

challenges for explosion proof, intrinsically safe electronics products including medical gas monitors, fixed gas

detectors, and air samplers

• Reviewed existing systems & procedures and designed internal controls/quality audit checks for various

operational areas for achieving higher operational efficiency, resource rationalization and cost reduction

• Actively involved in preparation of the product development report, master formula card, process optimization

protocol and stability protocol

2/2002-9/2004 Quality Assurance and Compliance Manager/Document Control Manager/Quality

Assurance Product Review and Release Manager, Watson Laboratories, Miami, FL

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• Facilitated the plant closure, product transfer and information exchange with recipient sites as a key

management team member

• Spearheaded the product review and release, document control, compliance and training teams

Career Summary contd.

• Adroitly led project to evaluate competencies and deploy general and job-specific training curricula

• Accomplished the responsibility to develop site process and procedures for deploying corporate policies;

developed efficient archival programs in addition to managing budgets and personnel

• Accountable for leading multi-site corporation wide team for change control process standardization; acted as

a team-member and site liaison for a corporation wide complaints handling and CAPA standardization team

• Provided regulatory guidance to ensure all post-marketing activities associated with the company's production

were in compliance with FDA's regulations and guidance

• Interacted with the senior management, team, and associates to facilitate smooth communication to understand

and analyze the requirement and also to identify appropriate solutions for problems

4/2001-present Private Compliance and Validation Consultant, FL

• Providing compliance and quality consulting services for manufacturers of branded and generic liquid and

solid drug products, medical devices and safety products for companies located throughout South FL and Tampa

Bay, MD/DC, and IN

• Dexterously perform technical assessments and gap analysis and supply regulatory guidance to clients in

compliance with FDA expectations and cGMP’s for quality systems, validation programs and cleaning validation

and master plans

• Assume initial and interim site and corporation responsibility for quality operations, compliance and materials

disposition

• Instrumental in client interdepartmental and inter-company negotiations, including directing and coordinating

activities of validation contractors, staff management and resource planning to meet customer timelines and

control cost

• Gear the activities for the development and implementation of the core quality system for operations start-up

of manufacturing sites including CAPA systems

• Distinction of providing consulting services to various major pharmaceutical and generic manufacturers

located primarily in Northern NJ

• Build an extensive client and contractor contact including directing and coordinating activities of third-party

validation contractors

• Deliver high quality and on-time regulatory submissions/filings to the FDA and other competent authorities

11/2000-4/2001 Quality Assurance Manager, Schweizerhall Manufacturing Co., Greenville, SC

5/1996-7/2000 Quality Assurance Manager/Quality Control Manager/Laboratory Manager, Vital

Pharma Inc., Riviera Beach, FL

4/1990-4/1996 Quality Control Chemist/ Analytical Chemist/ R&D Chemist, Becton Dickinson Co.,

Hunt Valley, MD

Education and Qualifications

Bachelor B.A. – Chemistry, University of Maryland, BaltimoreCounty, Baltimore, MD, 1989

Further Training

Certifications Master Certificate Six Sigma – Black Belt, Lean Six Sigma and Greenbelt Coursework –

Villanova University, 2006-2008

Certificate in Regulatory Affairs from RAPS

Further Skills

IT Skills Ms Office

Languages English

Personal Details

Driving license Full/Clean

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Interests include Family, Fishing, Golf, Soccer

References are available on request

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