Fredrick Williams
Georgetown,TX
Summary
Quality Professional Project Manager Servant Leader Proficient operational, quality, and regulatory professional with 21+ years of experience in both the bio therapeutics and medical care industry. 10+ years of successful utilization of transparent communication fostering customer focus and quality culture within organizations. Managed ten new center openings, Quality Management System development, domestic, international, and other regulatory requirements with efficient implementation, staff mentorship and training efforts for various businesses. Precise Quality Assurance Manager proficient in all QA operations, policies and procedures. Experience hiring and developing individual team members. Committed to thoroughly assessing product quality and manufacturing processes to achieve excellent results and customer satisfaction.
Overview
16
16
years of professional experience
Work History
Director of Quality
Grifols Biomat USA
12.2021 - 07.2023
- Develop and implement divisional quality strategies with corporate leadership
- Collaborate closely with director of operations to ensure environment of compliant collections
- Act as liaison for completion of regulatory paperwork for 36 donor centers in Texas and Oklahoma
- Ensure author responses from center are reviewed and submitted to compliance
- Host external audits for United States and European Agencies and oversee corrective actions
- Provide standardization of quality measures based on data analysis and latest quality management standards
- Exceeded and improved KPI's score to above 90 which constitutes 20-point increase for entire business unit
- Reduced overall findings from FDA and European audits over 10% between 2021-2022 by increasing regional oversight to donor centers
- Improved overall internal compliance rating to average of 1.5 on 3-point scale by collecting and analyzing data/ focusing on areas on improving opportunity.
- Determined quality department standards, practices, and procedures.
- Established and tracked quality department goals and objectives.
- Applied coaching techniques and tools to support managers and team members in improving performance.
Manager of Process & Technology
Grifols Biomat USA
01.2019 - 12.2021
- Led continuous process improvement and technology initiatives for 72 plasma donation centers leading rollout of new donor management system and medical equipment
- Led five teams over 12+ individuals from payroll, transportation, procurement, facilities, human resources, marketing, public affairs, compliance, and regulatory in developing effective processes, procedures, and business requirements
- Provided training on new processes for improvement to over 120 employees by monitoring their training status and reporting their progress
- Engaged company technology teams to create and implement strategic solutions that leverage infrastructure, capitalizing on new technologies, and integrate with business operations
- Reduced company's risk of depending on old technology by introducing new donor management system into live environment in 5+ sites
- Saved company over $2 million in 12 months by reducing unnecessary supplies and equipment from daily operations
- Decreased company ROI time by 20 months by creating new center teams to open five new facilities in region.
- Recommended equipment and supplies purchases to meet operational requirements of business.
- Opened and closed location and monitored shift changes to uphold successful operations strategies and maximize business success.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Successfully managed budgets and allocated resources to maximize productivity and profitability.
Regional Quality Manager
Grifols Biomat USA
01.2013 - 01.2019
- Hosted Food and Drug Administration (FDA) and European Medical Agency (EMA) audits and writing, editing, and reviewing audit response
- Directed quality operations of eight donor collection centers by providing quality leadership and guidance while maintaining compliance with all applicable state, federal, international regulatory, and company requirements
- Maintained thorough familiarity with current manufacturing practice, state, federal and international medical regulations
- Achieved zero FDA observations in six facilities during routine audits over three years by focusing on employee satisfaction
- Reduced raw material waste by more than 15% over three years by improving quality teams reviews
- Eliminated 20% of shipping errors with implementation of pre-staging reviews.
- Established and tracked quality department goals and objectives.
- Determined quality department standards, practices, and procedures.
- Applied coaching techniques and tools to support managers and team members in improving performance.
Regional Operations Manager
Grifols Biomat USA
01.2008 - 01.2013
- Directed plasma operations of eight donor centers in Midwest Region providing leadership and guidance while maintaining compliance with all applicable state, federal, international regulatory, and company requirements
- Led operational teams responsible for interpreting and implementing company policies and procedures
- Reviewed activities of region to ensure continued plasma operations, to maximize return on investment and to increase productivity
- Ensured and promoted development of regional management team through coaching, training, and leadership development
- Region exceeded budget production by more than 12 % and was below cost by more than $5.00 per liter totaling over $1.5 million
- Decreased staff turnover by more than 20% over five years by increasing employee satisfaction
- Led growth of each center in region by more than 5% and did not exceed annual budget.
- Led weekly meetings with regional staff to review progress, address challenges and drive timely task completion.
- Collaborated with cross-functional teams to align operations with corporate objectives.
- Spearheaded operational procedures and processes to improve efficiency and optimize operations.
- Monitored and analyzed performance data, identifying areas of improvement and developing corrective action plans.
- Enforced compliance with local, state and federal regulations and company standards.
- Scheduled employees for shifts, taking into account customer traffic and employee strengths.
- Implemented innovative programs to increase employee loyalty and reduce turnover.
Education
MBA -
Indiana Wesleyan University
Marion, IN08.2008
Bachelor of Science - Management/Human Resource
Park University
Kansas City, MO06.2001
Skills
- Customer Satisfaction
- Total Quality Management
- Quality Inspection and Control
- Employee Performance Reviews
- Corrective Actions
- Quality Improvement Initiatives
- Audit Process Management
- CGMP Regulations
- Quality Assurance
- Regulatory Assurance
- Data Integrity
- Change Management Process
Affiliations
American Society Quality
Alpha Phi Alpha Fraternity Inc.
National Black MBA Association Inc
Timeline
Director of Quality
Grifols Biomat USA
12.2021 - 07.2023
Manager of Process & Technology
Grifols Biomat USA
01.2019 - 12.2021
Regional Quality Manager
Grifols Biomat USA
01.2013 - 01.2019
Regional Operations Manager
Grifols Biomat USA
01.2008 - 01.2013
MBA -
Indiana Wesleyan University
Bachelor of Science - Management/Human Resource
Park University
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