Mickaela Blake Pmp Email & Phone Number | Successful career experience in senior management roles within the pharmaceutical and biotechnology industry - Astellas, AbbVie, Merck and Pfizer. Highly skilled PMP and Quality Director leveraging expertise in Lean Six Sigma Green Belt, risk management, best practices and quality methodologies to deliver high-quality outcomes in all projects and programs. Solid expertise in multiple quality systems, regulatory requirements, data integrity, accurate reporting, technical R&D, white papers, SOP improvements and multimedia presentations; fully accountable for inspection management, system support and new product lifecycles. Proficient in closely collaborating with internal business partners, quality organizations, R&D units, legal entities, consultants, key decision-makers and multi-discipline resources in planning and executing complex and technical redevelopment initiatives. Leadership of cross-functional teams and stakeholders to ensure full compliance with regulatory requirements, good practices and internal standards. Confident administration of initiatives to continually enhance efficiency, effectiveness and innovation in the medical affairs processes and systems. One of my recent achievements was receiving the Astellas Rising Star award for new employees who made a significant impact with peak job performance. Professional mission statement: to drive excellence, continuous improvement and a thriving culture of quality compliance that contributes to the advancement of patient care and health outcomes. * Proficient in MS Office Suite, Trackwise, Cybergrant, Salesforce and project management software. * Volunteer for local food bank. Pharmaceutical Development ● Multi-Project Management ● Policy Formation ● Quality Assurance ● Process Reengineering ● Strategic Planning ● Data Integrity ● Resource Allocation ● Multisite Operations ● Best Practices ● Requirements Gathering ● Quality System Implementation ● Vendor Relations ● Project Expediting ● Inspection Oversight ● Risk Mitigation ● Functional Benchmarking ● Partner Due Diligence ● Operational Streamlining ● VIP Presentations ● Clinical Studies ● Medical Affairs ● System Administration ● Technology Deployment ● Regulatory Compliance ● Change Management

Mickaela Blake Pmp

Successful career experience in senior management roles within the pharmaceutical and biotechnology...
Chicago, Chicago, United States

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Mickaela Blake Pmp’s Email mickaela.blake@astellas.com

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Mickaela Blake Pmp’s Location Chicago, Chicago, United States

Mickaela Blake Pmp’s Current Industry Astellas Pharma

Mickaela Blake Pmp’s Prior Industry Abbvie | Merck | Pfizer

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Work Experience

Astellas Pharma

Associate Director - Regional Process and Quality Medical Affairs

2020-01-01T00:00:00.000Z - Present

Abbvie

Clinical QA Program Manager

2016-01-01T00:00:00.000Z - 2020-01-01T00:00:00.000Z

Merck

Third-Party Quality Associate Director

2012-01-01T00:00:00.000Z - 2014-01-01T00:00:00.000Z

Pfizer

Senior Quality Assurance Specialist

2004-01-01T00:00:00.000Z - 2007-01-01T00:00:00.000Z

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FAQ About Mickaela Blake Pmp

Mickaela Blake Pmp is located at
Chicago, Chicago, United States

Mickaela Blake Pmp is a Successful career experience in senior management roles within the pharmaceutical and biotechnology industry - Astellas, AbbVie, Merck and Pfizer. Highly skilled PMP and Quality Director leveraging expertise in Lean Six Sigma Green Belt, risk management, best practices and quality methodologies to deliver high-quality outcomes in all projects and programs. Solid expertise in multiple quality systems, regulatory requirements, data integrity, accurate reporting, technical R&D, white papers, SOP improvements and multimedia presentations; fully accountable for inspection management, system support and new product lifecycles. Proficient in closely collaborating with internal business partners, quality organizations, R&D units, legal entities, consultants, key decision-makers and multi-discipline resources in planning and executing complex and technical redevelopment initiatives. Leadership of cross-functional teams and stakeholders to ensure full compliance with regulatory requirements, good practices and internal standards. Confident administration of initiatives to continually enhance efficiency, effectiveness and innovation in the medical affairs processes and systems. One of my recent achievements was receiving the Astellas Rising Star award for new employees who made a significant impact with peak job performance. Professional mission statement: to drive excellence, continuous improvement and a thriving culture of quality compliance that contributes to the advancement of patient care and health outcomes. * Proficient in MS Office Suite, Trackwise, Cybergrant, Salesforce and project management software. * Volunteer for local food bank. Pharmaceutical Development ● Multi-Project Management ● Policy Formation ● Quality Assurance ● Process Reengineering ● Strategic Planning ● Data Integrity ● Resource Allocation ● Multisite Operations ● Best Practices ● Requirements Gathering ● Quality System Implementation ● Vendor Relations ● Project Expediting ● Inspection Oversight ● Risk Mitigation ● Functional Benchmarking ● Partner Due Diligence ● Operational Streamlining ● VIP Presentations ● Clinical Studies ● Medical Affairs ● System Administration ● Technology Deployment ● Regulatory Compliance ● Change Management