Open To Work
Frances Brostrom
Pharma/Biotech Quality Specialist
Grove City,OH
Work Preference
Summary
Results-driven leader specializing in cGMP compliance and quality management systems. Demonstrated success in implementing process improvements that enhance operational efficiency. Skilled in fostering cross-functional collaboration to achieve strategic objectives.
Overview
22
22
years of professional experience
Work History
QMS Senior Manager
Forge Biologics
Grove City, OH
11.2024 - 05.2026
- Led cross-functional teams to achieve project milestones, ensuring collaboration and efficiency.
- Reported to executive leadership on performance metrics, challenges, and strategic opportunities.
- Implemented process improvements to increase operational efficiency and reduce costs.
- Monitored compliance with industry regulations and company policies to mitigate risk.
- Oversaw quality assurance efforts to maintain high standards of product and service delivery.
- Implemented customer service excellence standards to enhance client satisfaction and loyalty.
- Managed crisis situations, implementing contingency plans to minimize impact on operations.
- Facilitated team meetings and workshops to align on goals and strategies.
- Conducted performance reviews and provided feedback to direct reports for career development.
- Guided change management initiatives to ensure smooth adoption of new business practices.
- Established and maintained relationships with key stakeholders to support business objectives.
- Oversaw talent acquisition, training, and development programs to build high-performing teams.
- Reviewed current standards and policies.
- Established procedures and quality standards.
- Utilized statistical process control (SPC) and other quality tools to monitor process capability and product consistency.
- Fostered a culture of quality across the organization by promoting awareness and understanding of quality standards and their importance.
- Facilitated regular quality reviews with senior management, providing insights and recommendations for quality improvement.
- Directed the preparation and execution of internal and external audits, achieving compliance with FDA cGMP and ICH standards and other regulatory bodies.
- Established product specifications and quality assurance practices.
- Managed company onboarding processes, interviewing, and selecting new quality assurance personnel.
- Established quality metrics and benchmarks to measure performance and guide strategic decision-making.
- Completed various financial and quality audits for different departments.
- Managed supplier key performance indicators and checked materials for compliance with specifications.
- Updated and maintained documentation related to quality assurance processes, procedures, and reports to ensure regulatory compliance.
- Trained and mentored project leaders to drive culture change toward total quality mindset across production continuum.
- Collaborated with R&D, IT, Marketing, Client Relations, MS&T, Laboratory, Engineering, and Validation teams to establish quality criteria for new products, ensuring design for quality and manufacturability.
- Inspected, removed and replaced malfunctioning equipment and tools to minimize workflow disruptions.
- Led sustainability initiatives within the quality department, focusing on waste reduction and improving environmental impact.
- Trained and mentored quality assurance staff, enhancing their skills and knowledge in quality standards and best practices.
- Managed continuous improvement strategies to improve manufacturing margins and reduce costs.
- Represented the quality assurance department in cross-departmental meetings, contributing to strategic planning and operational efficiency.
- Managed the development and maintenance of quality management systems (QMS), ensuring continuous improvement and efficiency. Focus on non-conforming quality events, root cause analysis, CAPA's, customer complaints, and change controls.
- Analyzed quality control data to identify trends, root causes of issues, and areas for improvement in processes and product quality.
- Developed and implemented comprehensive quality assurance policies and procedures to meet industry standards and regulatory requirements.
- Coordinated with production and development teams to integrate quality assurance measures into all phases of product lifecycle.
- Troubleshot product issues and fixed problems.
- Fielded customer complaints and rectified service issues.
- Implemented corrective and preventive action (CAPA) systems, significantly reducing defect rates and improving product reliability.
- Supervised and guided inspectors, technicians, and other staff.
- Managed customer complaints and non-conformance issues, ensuring swift resolutions and maintaining high levels of customer satisfaction.
- Identified needed resources and aligned with project milestones, deliverables, and prioritization for viable production planning.
- Compiled data on quality issues and vulnerabilities and reported findings with suggestions for improvement.
- Established and accomplished goals for improvements in profits, quality and delivery.
- Created, edited, and updated project manuals and technical documentation used by entire QA team.
- Kept records of quality reports and statistical reviews.
- Led cross-functional teams in conducting detailed product audits, identifying quality issues and ensuring compliance with specifications.
- Conducted risk assessments and validation activities to mitigate potential quality and compliance risks.
QC Microbiology Senior Manager
Bristol Myers Squibb
Summit, New Jersey
01.2022 - 07.2024
- Supported the FDA licensure of Breyanzi, a CAR T therapy developed for the treatment of multiple myeloma patients.
- Established and maintained relationships with key stakeholders to support business objectives.
- Implemented process improvements to increase operational efficiency and reduce costs.
- Conducted performance reviews and provided feedback to direct reports for career development.
- Managed crisis situations, implementing contingency plans to minimize impact on operations.
- Facilitated team meetings and workshops to align on goals and strategies.
- Guided change management initiatives to ensure smooth adoption of new business practices.
- Monitored compliance with industry regulations and company policies to mitigate risk.
- Led cross-functional teams to achieve project milestones, ensuring collaboration and efficiency.
- Oversaw talent acquisition, training, and development programs to build high-performing teams.
Senior Quality Assurance Manager
Bristol Myers Squibb
Summit, New Jersey
05.2019 - 12.2021
- Supported the FDA licensure of Abecma, a CAR T therapy developed for the treatment of multiple myeloma patients.
- Reviewed current standards and policies.
- Utilized statistical process control (SPC) and other quality tools to monitor process capability and product consistency.
- Fostered a culture of quality across the organization by promoting awareness and understanding of quality standards and their importance.
- Facilitated regular quality reviews with senior management, providing insights and recommendations for quality improvement.
- Directed the preparation and execution of internal and external audits, achieving compliance with ISO standards and other regulatory bodies.
- Established product specifications and quality assurance practices.
- Managed company onboarding processes, interviewing, and selecting new quality assurance personnel.
- Established quality metrics and benchmarks to measure performance and guide strategic decision-making.
- Completed various financial and quality audits for different departments.
- Updated and maintained documentation related to quality assurance processes, procedures, and reports to ensure regulatory compliance.
- Trained and mentored project leaders to drive culture change toward total quality mindset across production continuum.
- Collaborated with R&D teams to establish quality criteria for new products, ensuring design for quality and manufacturability.
- Inspected, removed and replaced malfunctioning equipment and tools to minimize workflow disruptions.
- Led sustainability initiatives within the quality department, focusing on waste reduction and improving environmental impact.
- Trained and mentored quality assurance staff, enhancing their skills and knowledge in quality standards and best practices.
- Managed continuous improvement strategies to improve manufacturing margins and reduce costs.
- Represented the quality assurance department in cross-departmental meetings, contributing to strategic planning and operational efficiency.
- Managed the development and maintenance of quality management systems (QMS), ensuring continuous improvement and efficiency.
- Analyzed quality control data to identify trends, root causes of issues, and areas for improvement in processes and product quality.
- Developed and implemented comprehensive quality assurance policies and procedures to meet industry standards and regulatory requirements.
- Coordinated with production and development teams to integrate quality assurance measures into all phases of product lifecycle.
- Troubleshot product issues and fixed problems.
- Fielded customer complaints and rectified service issues.
- Implemented corrective and preventive action (CAPA) systems, significantly reducing defect rates and improving product reliability.
- Supervised and guided inspectors, technicians, and other staff.
- Managed customer complaints and non-conformance issues, ensuring swift resolutions and maintaining high levels of customer satisfaction.
- Identified needed resources and aligned with project milestones, deliverables, and prioritization for viable production planning.
- Compiled data on quality issues and vulnerabilities and reported findings with suggestions for improvement.
- Monitored product trends and suggested changes.
- Oversaw supplier quality assurance programs, including audits and performance evaluations, to ensure adherence to company standards.
- Created, edited, and updated project manuals and technical documentation used by entire QA team.
- Kept records of quality reports and statistical reviews.
- Led cross-functional teams in conducting detailed product audits, identifying quality issues and ensuring compliance with specifications.
- Conducted risk assessments and validation activities to mitigate potential quality and compliance risks.
Quality Assurance Manager
Gates Foundation at Anschutz Medical Campus
Aurora, CO
01.2016 - 07.2018
- Established procedures and quality standards.
- Reviewed current standards and policies.
- Led sustainability initiatives within the quality department, focusing on waste reduction and improving environmental impact.
- Managed supplier key performance indicators and checked materials for compliance with specifications.
- Managed continuous improvement strategies to improve manufacturing margins and reduce costs.
- Managed customer complaints and non-conformance issues, ensuring swift resolutions and maintaining high levels of customer satisfaction.
- Trained and mentored quality assurance staff, enhancing their skills and knowledge in quality standards and best practices.
- Analyzed quality control data to identify trends, root causes of issues, and areas for improvement in processes and product quality.
- Collaborated with R&D, Engineering, Laboratory, Supply Chain, and Manufacturing teams to establish quality criteria for new products, ensuring design for quality and manufacturability.
- Compiled data on quality issues and vulnerabilities and reported findings with suggestions for improvement.
- Led cross-functional teams in conducting detailed product audits, identifying quality issues and ensuring compliance with specifications.
- Updated and maintained documentation related to quality assurance processes, standard operating procedures, and reports to ensure regulatory compliance.
- Conducted risk assessments (FME) and verification/validation activities to mitigate potential quality and compliance risks.
- Identified needed resources and aligned with project milestones, deliverables, and prioritization for viable production planning.
- Coordinated with production and development teams to integrate quality assurance measures into all phases of product lifecycle.
- Fielded customer complaints and rectified service issues.
- Monitored product trends and suggested changes.
- Developed and implemented comprehensive quality assurance policies and procedures to meet industry standards and regulatory requirements.
- Managed the development and maintenance of quality management systems (QMS), ensuring continuous improvement and efficiency.
- Facilitated regular quality reviews with senior management, providing insights and recommendations for quality improvement.
- Created, edited, and updated project manuals and technical documentation used by entire QA team.
- Established quality metrics and benchmarks to measure performance and guide strategic decision-making.
- Fostered a culture of quality across the organization by promoting awareness and understanding of quality standards and their importance.
- Managed company onboarding processes, interviewing, and selecting new quality assurance personnel.
- Trained and mentored project leaders to drive culture change toward total quality mindset across production continuum.
- Utilized statistical process control (SPC) and other quality tools to monitor process capability and product consistency.
- Implemented corrective and preventive action (CAPA) systems, significantly reducing defect rates and improving product reliability.
- Supervised and guided inspectors, technicians, and other staff.
- Represented the quality assurance department in cross-departmental meetings, contributing to strategic planning and operational efficiency.
- Kept records of quality reports and statistical reviews.
- Established and accomplished goals for improvements in profits, quality and delivery.
- Completed various financial and quality audits for different departments.
- Negotiated with suppliers and vendors to improve product quality, reduce costs, and ensure timely delivery of materials.
Senior Quality Assurance Specialist
Merck (MSD Europe)
Luzern, Switzerland
01.2011 - 07.2015
- Originally hired at Merck in Boulder, CO, to support the manufacture of a biosimilar. Accepted a three-year contract in Luzern, Switzerland, to perform a gap assessment on the quality systems. Supported the transition of the clinical manufacturing site to fully commercial FDA, EMA, Swiss Medic, Japan Health, and Canadian Health Authority licensure for Keytruda.
- Consulted with management and personnel to educate on QA standards.
- Collaborated with management to discuss effective plans for resolving major quality problems.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- Collaborated with the product development team to establish quality criteria for new products.
- Utilized root cause analysis techniques to identify and rectify quality-related problems.
- Coordinated with cross-functional teams to address quality issues and implement corrective actions.
- Developed and implemented comprehensive quality assurance programs to ensure compliance with industry standards and regulations.
- Assisted in the development and validation of testing methods for quality control purposes.
- Prepared reports to communicate results of quality inspection activities to management.
- Reorganized and revised standard operating procedures to streamline processes and improve communication and collaboration.
- Managed customer complaints, coordinating investigations, and ensuring effective resolutions.
- Analyzed production processes and product specifications to establish quality and reliability standards.
- Determined training needs of staff and organized training interventions to achieve quality standards.
- Conducted thorough inspections of incoming materials and finished products to ensure quality standards were met.
- Supported continuous improvement initiatives by analyzing performance data and recommending process enhancements.
- Facilitated training sessions for staff on quality assurance procedures and policies.
- Conducted risk assessments to identify potential quality issues and developed mitigation strategies.
- Updated and maintained the Quality Management System documentation to reflect current practices and regulatory changes.
- Led internal audits to identify areas for improvement and ensure adherence to quality management systems.
- Implemented quality control tools and methodologies to enhance product quality and reduce defects.
- Reviewed and approved quality-related documents, ensuring compliance with internal and external standards.
- Monitored and evaluated supplier performance to ensure compliance with quality requirements.
- Maintained accurate records of quality reports, statistical reviews, and relevant documentation.
- Oversaw calibration and maintenance of quality testing equipment to ensure precise measurements.
- Participated in external audits and regulatory inspections, providing necessary documentation and support.
- Collaborated with stakeholders to identify, investigate, and verify complex records and potential risk issues.
- Prepared and presented detailed reports on quality metrics, trends, and improvement initiatives to management.
Quality Assurance Specialist
Amgen
Boulder, CO
09.2006 - 06.2007
- Short term contract to provide quality support for team member out on medical leave.
- Monitored QA procedures for adherence by employees, notifying personnel of non-compliance issues.
- Consulted with management and personnel to educate on QA standards.
- Coordinated with cross-functional teams to address quality issues and implement corrective actions.
- Supported continuous improvement initiatives by analyzing performance data and recommending process enhancements.
- Managed customer complaints, coordinating investigations, and ensuring effective resolutions.
- Analyzed production processes and product specifications to establish quality and reliability standards.
- Prepared and presented detailed reports on quality metrics, trends, and improvement initiatives to management.
- Implemented quality control tools and methodologies to enhance product quality and reduce defects.
- Conducted thorough inspections of incoming materials and finished products to ensure quality standards were met.
- Collaborated with stakeholders to identify, investigate, and verify complex records and potential risk issues.
- Updated and maintained the Quality Management System documentation to reflect current practices and regulatory changes.
- Reviewed and approved quality-related documents, ensuring compliance with internal and external standards.
- Prepared reports to communicate results of quality inspection activities to management.
- Maintained accurate records of quality reports, statistical reviews, and relevant documentation.
- Utilized root cause analysis techniques to identify and rectify quality-related problems.
Formulations Supervisor
Thermo Biostar
Boulder, CO
01.2004 - 03.2006
- Trained as a facilitator and manager of continuous process improvement initiatives.
- Monitored employee productivity to provide constructive feedback and coaching.
- Led weekly team meetings to discuss progress, address issues, and plan future actions.
- Coordinated with other department supervisors to ensure smooth workflow and project alignment.
- Identified opportunities for process improvements, leading to cost reductions and increased productivity.
- Streamlined workflow processes, reducing project completion times.
- Addressed and resolved interpersonal conflicts within the team, maintaining a harmonious work environment.
- Managed team of 6 employees, ensuring high productivity and quality standards were met.
- Prepared and presented reports on team performance, challenges, and achievements to senior management.
- Managed scheduling for staff, ensuring adequate coverage during peak times and projects.
- Developed and maintained a safe working environment, adhering to all safety protocols and regulations.
- Conducted regular performance evaluations, providing constructive feedback and setting individual goals.
- Responded to customer questions regarding products, prices and availability.
- Complied with company policies, objectives and communication goals.
- Oversaw inventory management, ensuring adequate stock levels and reducing waste.
- Implemented quality control measures, significantly reducing error rates.
- Monitored employee attendance, addressing any punctuality or absenteeism issues.
- Trained new employees on company policies, job duties, and performance expectations.
- Managed budget for department, ensuring all expenses stayed within allocated funds.
- Fostered a positive and motivating work environment, leading to an increase in team morale.
- Resolved customer complaints and issues promptly, ensuring customer satisfaction and loyalty.
- Implemented new operational procedures, increasing efficiency.
- Acted as a liaison between upper management and staff, facilitating open communication.
Education
Master of Science - Organizational Leadership
Colorado State University
Fort Collins, CO05-2017
Bachelor of Science - Biololgy
The University of Texas At San Antonio
San Antonio, TX05-1992
Skills
- cGMP compliance
- Quality Management Systems: non-conformance, corrective and preventive actions, root cause analysis, change controls, continuous process improvement, lean manufacturing, six sigma, etc
- CDMO Client Interactions
- Inspection Readiness
- Verification/Validation
- Business performance management
- Reporting oversight
- Cross-functional team coordination
- Logistics support services
- Material accountability systems
- Sales channel analytics
- Human resources management
- Property storage management
- Logistics operations management
- Cargo loading and handling
- Warehousing functions
- Corporate communications
- Market analysis
- Budget oversight
- Database development
- Resource allocation
- Industrial engineering
- Data analytics
Timeline
QMS Senior Manager
Forge Biologics
11.2024 - 05.2026
QC Microbiology Senior Manager
Bristol Myers Squibb
01.2022 - 07.2024
Senior Quality Assurance Manager
Bristol Myers Squibb
05.2019 - 12.2021
Quality Assurance Manager
Gates Foundation at Anschutz Medical Campus
01.2016 - 07.2018
Senior Quality Assurance Specialist
Merck (MSD Europe)
01.2011 - 07.2015
Quality Assurance Specialist
Amgen
09.2006 - 06.2007
Formulations Supervisor
Thermo Biostar
01.2004 - 03.2006
Master of Science - Organizational Leadership
Colorado State University
Bachelor of Science - Biololgy
The University of Texas At San Antonio