LiveCareer-Resume

senior director quality management resume example with 20+ years of experience

Jessica Claire
  • , , 609 Johnson Ave., 49204, Tulsa, OK 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Summary

Experienced and driven Director gifted in building strategic industry partnerships, coordinating tactical plans and devising proactive strategies focused on enabling growth and maintaining a quality culture. Upholds holistic oversight of Quality Management System planning, improvements, and maintenance, and brings 22 years of global bio-pharmaceutical research and development experience. Adept at directing infrastructure development and integration as a key Quality Management leader. Talented communicator with a persuasive style and results-driven approach.

Skills
  • Team Leadership
  • Training and Development
  • Project Planning
  • Verbal and Written Communication
  • Documentation and Reporting
  • Complex Problem Solving
  • Teamwork and Collaboration
  • Customer Service
Experience
Senior Director, Quality Management, 01/2020 to Current
Applied Molecular Transport Inc.South San Francisco, CA,
  • Neuroscience Business Unit Quality Head.
  • Real-World Evidence/ Late Phase Unit Quality Head.
  • Develop and direct quality management system to support the overall business objectives and strategic goals.
  • Provide expert consultation on highly complex aspects of ‘GxP’ through interdepartmental collaborations with internal and external business partners.
  • Influence and drive process improvements and facilitate change management initiatives required to meet evolving regulatory requirements and industry standards.
  • Oversee and sponsor development of quality or process-related initiatives, procedures, and training.
  • Quality oversight to strategic and alliance partners through governance, including marketing meetings, project meetings, and client relationship meetings.
  • Risk management and maintenance of key quality indicators and metrics for business units'.
  • Interdepartmental coordination to improve business transactions through data analysis and implementation of lean strategies.
  • Partnered with staff to create professional development plans to support personal and business growth.
Director, Clinical Quality Assurance , 08/2017 to 12/2019
Novavax Inc.Gaithersburg, MD,
  • Maintained oversight of the Global Quality Assurance organization, including Corporate Quality, Development Innovations Quality Assurance (Contract Research Organization (CRO)), and Clinical Quality Assurance (Site Management Organization (SMO)).
  • Partnered with business, physician, and operational leadership to establish roadmap for quality program implementation across critical functions.
  • Built and managed the performance and development of all Quality Assurance systems, processes, personnel, budget, and goals in‐line with the strategic goals of the organization.
  • Implemented quality improvement activities to raise performance and efficiencies of company’s products and deliverables.
  • Management, reporting and escalation of prioritized quality metrics, systemic deviations, quality issues and opportunities for improvement to Executive and Physician Leadership.
  • Vendor Risk Management with established classification system for critical vendors, monitoring vendor performance, key quality indicators, and annual audit planning.
  • Provided guidance and mentoring to all colleagues regarding their impact in the quality management system and other quality concepts, including ICH‐GCP, and other regional and local regulatory compliance.
  • Served as the management and escalation point for scientific misconduct and/or fraud investigations, impact assessment(s), and serious breach reporting.
  • Ensured Quality Management System adherence with oversight of action plans (i.e., audits, Corrective Action/Preventive Action (CAPAs), Non-Conformances, etc.).
  • Developed, modified, and reviewed policies and procedures.
  • Planned and implemented strategies to grow revenue.
  • Supported work-life balance to improve staff morale.
  • Drafted mission and vision statements to outline objectives and motivate employees.
  • Tracked quality improvement activities to assess trends and report findings to senior leaders.
Director, Quality Assurance (Americas Head), 02/2016 to 08/2017
INC ResearchCity, STATE,
  • Development and implementation of the global Quality Assurance (QA) Program for the Americas.
  • Recruited, hired and trained quality assurance staff.
  • Performed line management responsibilities for quality assurance staff, including professional development, performance appraisals, job description preparation, and employee counseling.
  • Managed and supported regulatory inspections of company offices, including oversight and management of inspection findings and responses.
  • Met with stakeholders to address issues and implement solutions.
  • Defined and implemented departmental metrics to meet quality objectives.
  • Consulted and proposed strategies for improvement to quality and compliance for operational and functional services.
  • Led and contributed to Corporate-wide strategic initiatives.
Associate Director, Corporate Quality Relationship, 01/2015 to 01/2016
INC ResearchCity, STATE,
  • Provided senior management quality oversight to strategic and alliance accounts.
  • Managed client relationships to deliver high levels of client satisfaction, trust and strong partnerships.
  • Partnered and collaborated with strategic and alliance partners to develop and execute quality management expectations across portfolio deliverables through key quality or key performance indicators.
  • Interpreted key performance indicators, determining root cause for variances while implementing solutions to improve outcomes.
  • Analyzed trends to drive organizational effectiveness and develop workforce plan aligned with business strategy and objectives.
  • Collected, analyzed and interpreted data to assist with project decisions and prioritization.
  • Incorporated thought leadership and utilized best practices to achieve consistency in product delivery.
Manager, Clinical Quality Assurance , 01/2012 to 01/2015
ICON Clinical ResearchCity, STATE,
  • Management of strategic and alliance relationships to deliver quality oversight and governance for the relationship.
  • Liaised with clients (internal and external) regarding quality aspects of clinical programs.
  • Managed, facilitated, and supported surveillance audits.
  • Supervised clinical quality assurance auditors, inclusive of activities such mentoring and assigning tasks to fit skills and maximize team performance.
  • Management of audit and inspection readiness.
  • Ensured issues were formally and consistently reported and corrective/preventive actions (CAPAs) address systemic gaps.
  • Forecasted quality indicators by review of historical internal and external trends and analytic reporting.
  • Coordinated and monitored systemic process improvements and quality initiatives with a focus on streamlining processes, adding value to the business, and meeting client expectations.
  • Verified relevant new contracts and cost proposals for quality deliverables.
  • Maintained quality systems and procedures, to align with changes in laws, standards and regulations.
Clinical Quality Assurance Auditor, 08/2006 to 12/2011
ICON Clinical ResearchCity, STATE,
  • Planned, coordinated, conducted and reported quality assurance audits (internal, external, and/or contracted) to assess GxP compliance and adherence to standards and regulations.
  • Highlighted compliance issues for management team.
  • Laid out suggestions to improve quality controls and operations standards.
  • Outlined standardized procedures for company inspections and process reviews.
  • Built relationships with customers to facilitate communication.
  • Scheduled client visits and planned assessments.
  • Made travel plans and conducted assessments at clients' facilities.
  • Trained and mentored junior clinical quality assurance auditors and provided a benchmark of auditing competencies to less experienced colleagues.
  • Conducted induction and training of new staff regarding quality policies and procedures.
Clinical Research Associate/ Project Lead, 06/2000 to 08/2006
ICON Clinical ResearchCity, STATE,
  • Adhered to good clinical practices, operating procedures and regulatory requirements.
  • Checked electronic data capturing systems for integrity and compliance.
  • Reported to project manager for issues related to overall study status.
  • Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
  • Conducted all activities according to defined project-specific quality and performance standards.
  • Performed pre-study, closeout and interim visits to check on study activities.
  • Coached team members on best practices for conducting effective studies.
  • Participated in educational training, activities and professional development programs.
  • Attended investigator meetings to provide framework for successful research studies by establishing responsibilities.
  • Achieved project-specific quality and performance standards and provided documentation and communication.
Education
Masters Business: Administration – Health Care Administration, Expected in 12/2021
University of North Alabama - Florence, AL
GPA:
  • Magna cum laude graduate
Bachelor of Science: Biosciences and Mathematics, Expected in 08/1999
Belmont University - Nashville, TN,
GPA:
  • Chi Beta Phi Member
Activities

Association of Clinical Research Professionals (ACRP)

- Member Since May 2018

AVOCA Quality Consortium

- Member Since January 2015

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

Your data is safe with us

Any information uploaded, such as a resume, or input by the user is owned solely by the user, not LiveCareer. For further information, please visit our Terms of Use.

Resume Overview

School Attended

  • University of North Alabama
  • Belmont University

Job Titles Held:

  • Senior Director, Quality Management
  • Director, Clinical Quality Assurance
  • Director, Quality Assurance (Americas Head)
  • Associate Director, Corporate Quality Relationship
  • Manager, Clinical Quality Assurance
  • Clinical Quality Assurance Auditor
  • Clinical Research Associate/ Project Lead

Degrees

  • Masters Business
  • Bachelor of Science

By clicking Customize This Resume, you agree to our Terms of Use and Privacy Policy

*As seen in:As seen in: