David Frame
Livingston
Summary
Seasoned Quality Leader | 23+ Years in Medical Device & Pharmaceuticals Proven track record of driving sustainable business improvements through robust quality management systems, honed across 23+ years in leading Medical Device and Pharmaceutical companies. Adept at strategising, implementing, and maintaining quality systems in both startups and established businesses, ensuring regulatory compliance across Europe, APAC, and Americas regions. Extensive experience leading remote international teams through process and change management initiatives, fostering collaboration and delivering results. Certified Lead Auditor with 20+ years of international auditing experience.
Overview
26
26
years of professional experience
Work History
QA & Regulatory Affairs Manager
Babylon Health (Software as a Medical Device)
03.2023 - 12.2023
- Directed and developed the QMS department to ensure that all aspects of the quality system were routinely followed and ready for ISO13485 inspection, leading to 40% increase in compliance within document management and non-conformance/CAPA process metrics
- Oversaw and approved regulatory assessments for software releases, clinical evaluations report & incident management assessments ensuring 100% compliance to timeline bound metrics
- Established crucial regulatory interactions and communications with regulators, notified bodies and other authorities
- Facilitated global compliance with medical device regulations and guidelines, acting as primary PRRC (Person Responsible for Regulatory Compliance), ensuring that Medical Device Directive (MDD) regulations were met whilst transitioning to Medical Device Regulation (MDR)
- Maintained on-going development of company QMS through continuous monitoring of processes and publishing of quality, PMS metrics & management review
- Collaborated with business leaders to determine product portfolio for legacy Babylon Health products and decommissioning products once end of life had been determined.
Quality Operations Manager
Abbott Rapid Diagnostics (IVD)
01.2018 - 03.2023
- Led cross-departmental efforts with QA/RA business leaders to foster a quality culture and compliance across the IT organisation, ensuring global Abbott facilities maintained compliance with ISO13485 & 21 CFR Part 820 while remaining audit-ready
- Created and implemented a process of regular reporting to managers/senior management of training assigned to direct reports that were due/overdue and increased compliance from 55% to 96% within 3 months of implementation
- Headed successful deployment of Abbott's quality and IT procedures and policies across the Alere business during transition phase, addressing any gaps identified
- Proactively identified the need for an Audit Support Plan for each global application due to rising number of unplanned audits, subsequently designing and implementing a process which facilitated 100% delivery of audit requests on time
- Led successful implementation of a global software lifecycle process, standardising methodologies for validation and management of all electronic systems, with no audit findings from regulatory bodies on the process after implementation
- Established IT vendor risk management program, mitigating cyber and quality risks associated with third-party software and services impacting Abbott's IT network
- Implemented a periodic review process for global applications ensuring that all findings were remediated and implemented within agreed timescales
- Led operational activities to improve compliance by releasing a guidance document on the SLC for Agile Methodology & Developed and led a validation strategy/approach for SAAS based solutions that had regular compulsory vendor releases.
- Established positive and effective communication among unit staff and organization leadership, reducing miscommunications, and missed deadlines.
- Set, enforced, and optimized internal policies to maintain responsiveness to demands.
- Implemented process improvement to shape organizational culture, optimize procedures for higher efficiency and help company evolve and grow.
- Introduced new methods, practices, and systems to reduce turnaround time.
- Analyzed and reported on key performance metrics to senior management.
- Developed and maintained relationships with external vendors and suppliers.
- Led hiring, onboarding and training of new hires to fulfill business requirements.
- Supervised operations staff and kept employees compliant with company policies and procedures.
- Developed systems and procedures to improve operational quality and team efficiency.
- Directed initiatives to improve work environment, company culture or overall business strategy.
- Reduced process bottlenecks by training and coaching employees on practices, procedures, and performance strategies.
- Assisted in recruiting, hiring and training of team members.
- Observed each employee's individual strengths and initiated mentoring program to improve areas of weakness.
- Reduced operational risks while organizing data to forecast performance trends.
Senior Quality Engineer
Alere International, (IVD)
06.2014 - 01.2018
- Spearheaded global validation and roll-out of the Agile PLM system for Alere, leading a cross-functional team in implementing across more than 70 sites
- This initiative centralised document management, complaints, audits, non-conformances, and CAPA processes within the corporate system, allowing the introduction of metrics to track compliance and regulatory alignment
- Successfully led the validation of the METRO Learning Management System, driving generation and tracking of global training metrics for improved performance measurement
- Developed and implemented comprehensive supplier management process
- This process assessed vendor business risk by incorporating non-conformance/CAPA data, audit findings, and validation results into a scoring system
- Leveraged strong communication and project management skills to define a standardised global process for quarterly system updates, resulting in improved stakeholder engagement and smooth system rollouts.
- Supported quality team members during corrective action updates.
- Coordinated with quality control staff to complete inspections.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Maintained compliance with industry standards and regulatory compliance during managed projects.
- Recommended revisions to internal controls and operational and management policies and procedures.
- Reported on non-compliance issues and other negative factors discovered during production.
- Partnered with senior management to analyze issues and find appropriate solutions.
- Facilitated process improvements to successfully decrease errors.
- Escalated concerns about project and process quality, referring discovered issues to engineering manager for correction.
- Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues.
- Developed traceability documentation to aid in investigating faults and defects.
- Developed and implemented procedures to verify compliance with engineering standards.
- Led engineering teams to successfully complete projects on time and within budget.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Collaborated with other departments to facilitate successful project completion.
- Created detailed reports on engineering activities and findings.
- Documented and developed engineering procedures and processes.
- Developed and maintained relationships with suppliers to facilitate quality and timely delivery of materials.
- Conducted technical evaluations of engineering designs and test results.
Validation Engineer
Alere Technologies Ltd (IVD)
05.2009 - 06.2014
- Established and led company validation program, encompassing systems, equipment, facilities, processes, and products
- This ensured compliance with ISO 13485 and 21 CFR regulations, as well as internal company procedures, for all past and present validation activities
- Successfully managed the validation effort of world’s first fingerstick BNP (b-type natriuretic peptide) test as an aid in diagnosis and assessment of patients with heart failure
- Led management of internal and supplier audit program, implementing a risk-based approach to supplier audit schedule
- This prioritised audits based on pre- and post-launch product lifecycle stages, ensuring thorough quality assurance and risk mitigation throughout product development process
- Successfully managed validation of new facility and introduction of new product within planned timescales
- Achieved certification to ISO13485 first time with no non-conformances
- Eliminated all overdue audit actions by restructured Internal audit procedure to feed directly into existing non-conformance process to ensure appropriate focus was given to audit findings
- Reviewal of 510k submission data, technical files, design history files, post market surveillance reports
- Streamlined INR Disposition & Batch Release process to reduce labour intensity and opportunities for error, resulting in 20% reduction in time for batch release approval.
- Documented entire validation process, noting changes or alterations completed.
- Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
- Trained and assisted staff in validation techniques, methods and testing processes.
- Identified causes of equipment failures and made suggestions for issue resolution.
- Authored validation protocols for [Type] systems, verifying compliance with internal policies and external safety requirements such as [Area of Certification].
- Led risk assessment meetings, offering input on assessments such as system impact, component criticality, data integrity, and other factors.
- Collaborated on Standard Operating Procedure (SOP) development, incorporating input from [Type] team to reduce liability and enhance successful deployments.
- Developed validation master plans, process flow diagrams and standard operating procedures.
- Drove corrective actions to accomplish project closure and recurrence control.
- Worked with stakeholders and team members on quality assurance efforts for hardware components.
- Produced and maintained technical documentation for project reference.
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement.
- Met tight deadlines to satisfy client demands and project timelines.
- Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.
Quality Engineer / Complaints Manager
Haemonetics (IVD)
11.2002 - 05.2009
- Management of European complaints process through on-site direct reports and indirect staff members across Europe
- Approving complaint investigations, and generating complaint follow-up responses to local complaint coordinators
- Received Recognition Award from CEO after achieving 53% reduction in complaint closure turnaround time through streamlining European complaints process
- Boosted audit on-time completion from 60% to 100%
- Achieved 40% improvement in audit response timeliness
- Management and coordination of site internal QMS audit programme with 14 internal auditors, ensuring that audit schedule was kept up to date and all audits performed on time, ensuring continued compliance to ISO13485 and 21 CFR part 820 standards
- Liaise with senior management on process/product related issues and support manufacturing group projects to improve process controls and reduce costs
- Auditing against company and regulatory standards as part of European internal audit team responsible for identifying gaps in quality management system through on-going business transformation
- Management of CAPA programme within facility.
- Contributed to root cause analysis to determine core reason for failures and errors.
- Supported quality team members during corrective action updates.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Executed operational audits and assessed company operations, compliance and other associated risks.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Leveraged data and analytics to make informed decisions and drive business improvements.
- Identified and communicated customer needs to supply chain capacity and quality teams.
- Streamlined and monitored quality programs to alleviate overdue compliance activities.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
- Established team priorities, maintained schedules and monitored performance.
- Evaluated employee performance and conveyed constructive feedback to improve skills.
- Defined clear targets and objectives and communicated to other team members.
- Reviewed and prepared written correspondence to address complex and sensitive customer complaints and inquires.
- Oversaw communication and research to achieve full resolution of complaints inquiries.
- Established KPIs to oversee complaint volume, resolution time and other relevant metrics.
- Managed regulatory complaints team in activities associated with resolution of customer complaints received by federal and state regulators.
- Managed, mentored and developed team in delivering best-in-class escalated complaint resolutions.
- Collaborated with other departments to facilitate successful project completion.
- Analyzed and interpreted data to identify trends and recommend improvements.
- Led problem-solving activities to quickly identify and permanently resolve quality and productivity issues.
- Recommended revisions to internal controls and operational and management policies and procedures.
- Facilitated process improvements to successfully decrease errors.
- Partnered with senior management to analyze issues and find appropriate solutions.
- Maintained compliance with industry standards and regulatory compliance during managed projects.
- Reported on non-compliance issues and other negative factors discovered during production.
Site Audit Coordinator
GlaxoSmithKline (Active Pharmaceutical Ingredient)
02.2002 - 11.2002
- Acting as lead auditor in majority of audits against ICH Guidelines, ensuring mutual agreement of corrective actions, categorised and prioritised with appropriate target dates
- Publishing of audit reports and related analysis performance metrics to ensure visibility across site
- Reduced length of time for audit actions to be completed and number of open audit actions by 50%.
- Followed up to assess and report corrective action completion or progress.
- Administered auditing program to address risks and evaluate compliance with regulatory requirements.
- Developed and implemented corrective actions to bring business areas in line with standards.
- Established audit and internal control procedures and recommended process improvements to address issues.
- Followed established auditing processes to meet internal and regulatory requirements.
Quality Systems Specialist
Johnson & Johnson Medical (Wound Care)
02.1999 - 02.2002
- Substantial use of statistics, trend analysis and involvement in corporate six-sigma programme ‘Process Excellence’ and lean manufacturing programme ‘Manufacturing Excellence’
- Significantly reduced labelling and product mix up complaints across all products on site by more than 75% through introduction of line clearance procedures, and a “label shop” to control printing and reconciliation of all labels from one central location directly as a result of corrective action taken through complaints process
- Reduced complaints of “Dispos-a-glove” by 80% based on corrective actions implemented through complaints and Non Conformance procedures.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Applied coaching techniques and tools to support managers and team members in improving performance.
- Tracked quality issues with external customers, suppliers, and internal plant operations.
6 Sigma Black Belt
ABB Power T&D (Power Industry)
10.1997 - 02.1999
- Leading project teams to identify, establish and improve baseline business performance metrics
- Practical use of Six Sigma tools such as DMAIC methodology to improve productivity and reduce defects and costs
- Working as part of small team, mentoring and training personnel at all levels, as well as suppliers.
- Mentored and coached Six Sigma Green Belts in lean manufacturing and continuous improvement processes
- Led Six Sigma projects to streamline processes
Education
BEng.(Hons) 2nd. Class Upper Division - Manufacturing Engineering & Management
University of Strathclyde, Glasgow
Glasgow, United Kingdom06.1997
HND Mechanical Engineering -
Stow College,
Glasgow,06.1995
Skills
- Document & Change Control
- Non Conformance/CAPA Management
- Validation
- Computer Systems Validation
- Training Management
- Management Review
- Audit/Audit Management
- Regulatory Requirements
- Vendor/Supplier Management
- Risk Management
- Continuous Improvement
- Jira
- Confluence
- Agile PLM
- MasterControl
- Cornerstone
- Ensur
- SAP
- Slack
- Google Workspace
- Microsoft 365
- Lean Six Sigma
- Six Sigma Methodologies
Regulatory Knowledge
- ISO 9001
- ISO 13485
- ISO 14971
- ISO 27001
- MDD
- MDR
- ICH Q7a
- FDA 21CFR 820
- 21CFR 11
Courses Certifications
- ISEB Certified Tester Foundation Level
- Computer Systems Validation Course (21CFR Part 11)
- ISO 13485 Management Briefing Course
- ISO9001 Lead Auditor Certified
- Project Management Course (ECT Accredited)
- 6 Sigma Black Belt Certified
- MasterControl Process System Admin
- Statistical Tools for Quality Course
- Situational Leadership
- Kepner Tregoe: Conducting & Documenting Investigations
Timeline
QA & Regulatory Affairs Manager
Babylon Health (Software as a Medical Device)
03.2023 - 12.2023
Quality Operations Manager
Abbott Rapid Diagnostics (IVD)
01.2018 - 03.2023
Senior Quality Engineer
Alere International, (IVD)
06.2014 - 01.2018
Validation Engineer
Alere Technologies Ltd (IVD)
05.2009 - 06.2014
Quality Engineer / Complaints Manager
Haemonetics (IVD)
11.2002 - 05.2009
Site Audit Coordinator
GlaxoSmithKline (Active Pharmaceutical Ingredient)
02.2002 - 11.2002
Quality Systems Specialist
Johnson & Johnson Medical (Wound Care)
02.1999 - 02.2002
6 Sigma Black Belt
ABB Power T&D (Power Industry)
10.1997 - 02.1999
BEng.(Hons) 2nd. Class Upper Division - Manufacturing Engineering & Management
University of Strathclyde, Glasgow
HND Mechanical Engineering -
Stow College,
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