Lisa Clinkenbeard

Work History

Senior Quality Systems & Compliance Specialist/Project Manager

Bristol Myers Squibb (contract Hiregenics)

11.2018 - Current

Represent Cell Therapy divisions globally in meetings with Directors of Quality System and Compliance as Quality Management System Ambassador
Breaking down silos and ensure alignment across all BMS modalities acting as sounding board for Executive Leadership
Assumed interim responsibilities as Document Control Manager function for 6 months.
Oversaw critical tasks such as managing electronic document management system updates, document approvals, periodic review requirements, troubleshooting and integration activities.
Directed integration and data migration of heritage Celgene/Juno Cell Therapy division quality technology from eQRMS to Veeva QMS (Infinity) for Change Control and Deviation/CAPA modules
Led change management, communication, and system deployment to end users, including developing user training
Primary contact for support and guidance on Veeva QMS
Offer troubleshooting assistance, access guidance, and technical expertise in change control and deviation management
Serve as primary point of contact for inquiries and concerns related to KPI metrics within Cell Therapy division.
Collaborate closely with Global BMS Analytical Team to facilitate introduction or modifications of KPI metrics that may impact Cell Therapy.
Implemented robust record-keeping systems that ensured accurate documentation was maintained according to regulatory requirements at all times.
Served as point of contact for employees seeking guidance on compliance matters, instilling confidence in organization's commitment to regulatory adherence.
Assisted in preparation of regular reports for senior management, detailing compliance activities and progress towards established goals.
Reduced instances of non-compliance through meticulous monitoring of internal controls and periodic audits.
Evaluated existing policies regularly, identifying areas for improvement and recommending revisions as needed.
Conducted thorough risk assessments to identify potential areas of non-compliance and recommended corrective actions.
Analyzed data trends from ongoing monitoring efforts, utilizing insights gained to improve upon existing compliance initiatives further continually.
Served as subject matter expert by advising staff and customers and working directly with external agencies throughout audits or to remedy compliance issues.
Developed strategies for addressing identified gaps in regulatory knowledge within organization, enhancing overall compliance awareness.
Managed quality programs to reduce overdue compliance activities.
Enhanced company compliance by developing and implementing comprehensive policies and procedures.
Assisted in with Annual Complaint trend reports (Commercial and Clinical) and data to support regulatory complaint requests.
Stayed current on industry regulations by attending seminars, workshops, and other professional development opportunities.

PROJECT MANAGER SANDOZ INC., BROOMFIELD CO.

SANDOZ INC.

01.2005 - 08.2018

Completed Broomfield Mentor Training within LEAN/Six-sigma program, playing pivotal role in its development. Designed and conducted plant-wide courses in Visual Management and 5S.
Identified and facilitated recognition of process improvement opportunities in Finish Dosage Department, overseeing and contributing to over fifty-two projects. Led and mentored multiple 5S projects in Finish Dosage and QC Labs, including spearheading Intermediate Clean project for 2007/2008, resulting in cost savings exceeding $10,000. Actively involved in Product Yield Improvement Project and served as committee member for Plant discussion group for site project team (PDQ).
Provided valuable assistance to operators and supervisors in business case development of projects involving financial considerations.
Successfully managed multiple projects simultaneously by prioritizing tasks according to urgency, resource availability, and alignment with organizational goals.
Planned, designed, and scheduled phases for large projects.

Quality Systems and Compliance Lead

Sandoz INC.

01.2012 - 08.2018

Contributed to strategic planning and meticulous execution of site closure activities from QMS system shutdown, coordinating efforts with Global team, archiving paper documents, and coordinating site activities to ensure documents where properly archived.
Responsible for ensuring strict adherence to applicable procedures, GMPs, company policies, and regulatory requirements.
Managed Inspection site Readiness program, supporting health authority inspections in front-room, back-room, and as Subject Matter Expert (SME)
Led and supported internal audits, ensuring compliance with established quality standards
Formulated comprehensive training programs for Quality Systems users, significantly improving user proficiency.
Managed maintenance of existing Quality System databases in collaboration with IT, actively contributing to implementation of new databases
Led improvement projects to enhance Quality Systems, specifically change control, achieving significant 95% reduction in Change Control Deviations
Administered TrackWise and eSDMS with extensive expertise.
Provided comprehensive oversight of Broomfield Site Quality Metrics, including metric presentation for various forums such as Site Leadership Forums, Site Quality Council, North America Dashboards, and Global Quality Systems Review
Compiled and reported site metrics on global scale, ensuring alignment with organizational objectives
Worked collaboratively with site team to address and resolve identified complaint trend related to low count of tablets for controlled product originating from Packaging department.
Reviewed and approved customer complaints, actively participating in site collaboration to address identified trends.
Monitored and evaluated Quality Systems and procedures, ensuring alignment with Novartis Quality manual/Global operating Procedures and GMPs.
Functioned as Site Change Control Coordinator, overseeing change control process
Led bi-weekly change board meetings, offering guidance, oversight, and support to cross-functional departments utilizing centralized change control system.
Reduced operational risks with proactive identification and mitigation of system vulnerabilities.
Supported new business initiatives by ensuring seamless integration of systems and compliance requirements into project plans.
Boosted overall compliance by developing comprehensive policies and procedures aligned with industry best practices.
Maintained up-to-date knowledge on changing regulations, ensuring company systems remained compliant at all times.
Conducted regular training sessions for staff members to foster culture of compliance within organization.
Played crucial role in successful completion of external audits by providing accurate documentation and demonstrating adherence to regulatory standards.
Established solid relationships with external auditors, facilitating smooth audit processes and timely resolution of identified issues.
Implemented robust reporting mechanisms to keep senior management informed of compliance activities and potential areas of concern.
Developed and maintained system for tracking and reporting compliance violations.
Identified gaps in existing compliance processes and recommended updates.
Created and maintained compliant work environment.
Conducted periodic compliance audits and reviews to identify areas of improvement.

PRODUCTION FACILITATOR

SANDOZ INC.

01.2010 - 01.2012

Enhanced production efficiency by implementing streamlined processes and procedures.
Coordinated cross-functional teams for efficient workflow and timely project completion.
Boosted team productivity, providing ongoing training and skill development opportunities.
Implemented cost-saving measures, identifying areas of inefficiency within production process.
Established clear communication channels between departments to facilitate smooth operations.
Played instrumental role in successfully completing high-priority projects on time and within budget constraints.
Fostered positive work atmosphere by promoting teamwork, open communication, and mutual respect among colleagues.
Reduced downtime for equipment maintenance through proactive scheduling and task delegation.
Maintained safe work environment by enforcing strict adherence to safety protocols and guidelines.
Increased product quality with rigorous inspection processes and continuous improvement efforts.
Served as Member of US Sandoz Learning Council to ensure consistency in New Employee On-Boarding and On-the-Job Training across Sandoz sites in US. Developed and implemented new employee onboarding process aimed at enhancing productivity and reducing risks across all Sandoz facilities.
Performed and managed site wide training for cGMP training requirements such as Gowning and Personnel and Material flow.
Revamped and conducted training on Standard Operating Procedures (SOPs) to elevate quality standards and minimize deviations. Innovatively created, established, and provided training on new SOP format to support remediation efforts.
Collaboratively led remediation of change control process, conducting over one hundred risk assessments on change controls that had been pending approval in QMS system for over 2 years and longer.
Supported Regulatory Inspections and internal/customer audits as Training and Operations subject matter expert.
Designed and implemented more than ten new certification programs for Finished Dosage department, ensuring operators could effectively demonstrate competency in their roles.

PRODUCTION FINISHED DOSAGE LEAD

SANDOZ INC.

09.2000 - 01.2010

Enhanced product quality by implementing stringent inspection processes and addressing issues promptly.
Streamlined workflow efficiency by analyzing production processes and recommending improvements.
Achieved consistent on-time delivery with detailed scheduling and effective communication with team members.
Reduced material waste by optimizing resource usage and implementing recycling initiatives.
Collaborated with Planning, Blending, Microbiology Technical Services, and Maintenance teams to remove constraints in production schedule while meeting specific needs of each department.
Effectively managed schedule and planning for twenty operators, aligning with production priorities, and considering staffing and equipment constraints.
Enforce/Council/Train Operator compliance to SOPs, GMPs, OSHA, FDA, and DEA requirements & regulations.
Collaborated with In-process Quality Assurance counterparts to address and resolve quality-related concerns.
Aided production supervisors and operators in establishing production standards for equipment changeovers, actively contributing to implementation of continuous improvements to enhance and streamline processes.
Formulated and implemented performance standard metrics in collaboration with twenty operators, enabling supervisors to conduct quarterly and yearly reviews for over one hundred operators with supportive data.

Summary

Overview

Work History

Senior Quality Systems & Compliance Specialist/Project Manager

PROJECT MANAGER SANDOZ INC., BROOMFIELD CO.

Quality Systems and Compliance Lead

PRODUCTION FACILITATOR

PRODUCTION FINISHED DOSAGE LEAD

Education

BA in Project Management - Business Administration

Skills

Leadership Experience

References

Timeline

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