1. Sharon Monk Elledge
104 Tirzah, Lillington NC 27546
mselledge@yahoo.com C: (910) 591-9638 H: (910) 893-3417
SUMMARY
Seventeen year-experienced professional with nine years served in management positions
ensuring compliant product and process development and commercial product manufacturing
and stability/release testing.
EMPLOYMENT
GSK Vaccines (GSK acquired Novartis Vaccines), RTP, NC November 2013 - Present
Senior Manager Systems and Standards
(Promoted from Principal Specialist March 2015)
Ensure vaccine products and processes are designed, developed, and manufactured in a Quality
by Design (QbD) and cGMP phase appropriate manner.
• Created good science practice (GSP) guidelines for proper documenting, reviewing, and
storing of nonGxP experimental data for integrity, accuracy, reproducibility, and timely
retrieval purposes. Developed quality framework for cGMP phase-appropriate global
Quality Systems. Managing two direct reports to implement GSP guidelines, quality
framework, and improve the quality culture across all functions in global Technical
Development organization.
• Managing multiple cross-functions, matrixed teams to create and revise QbD guidance
documents. Increasing QbD usage across the global Technical Development organization
through awareness communications and training events.
Pfizer (Pfizer acquired Wyeth), Sanford, NC December 2002- October 2013
QA Stability and Validation Manager
Managed ten direct reports to assure GMP compliant stability program and compliant technical
transfers, qualifications, verifications, and validations. Spearheaded continuous improvement
efforts (defined standard work and associated touch times, improved visual management to
monitor workloads for ensuring proper work level loading, improved cross training within group
and department, and implemented a risk based Quality Assurance work order approval process).
QC Chemistry Manager
Managed ten direct reports to maintain a GMP compliant testing laboratory. Managed Lean Lab
initiative improving and maintaining efficient processes for Quality Control laboratory
operations. Achieved yearly reductions (10 to 20%) in laboratory investigation occurrences
through scientifically sound and compliant investigations with proper root cause identification
and timely completion of corrective and preventative actions. Ensured successful regulatory
authority audits due to performing pre-audit laboratory walkthroughs, document pre-reviews, and
responding appropriately to auditor questions. Set and maintained departmental annual budget.
Senior Quality Control Specialist II
Led project to create and implement global test methods, including validation and method
summaries resulting the successful regulatory submission of Prevnar 13®; additionally,

2. contributed to the project as a technical subject matter expert. Improved test methods for other
licensed products (Prevnar, HibTITER® and Meningtec®) and completed associated method
validation and comparability studies for regulatory filings. Ensured test method comparability
between multiple sites by monitoring controls and designing and coordinating multisite
(domestic and international) studies. Managed multisite teams to complete test method
qualifications, verifications, and validations and analytical instrument and associated software
qualifications. Aligned site procedures with corporate procedures.
Senior Supervisor
Managed five direct reports to complete test method qualifications, verifications, and validations;
analytical instrument and associated software qualifications; and implemented new technologies
in QC. Built better managers by training other individuals to be great leaders.
Senior Quality Specialist I
Improved test methods by conducting test method troubleshooting and remediation activities.
Bayer Corporation, Biological Division, Clayton, NC March 1999 - November 2002
Senior Associate Developmental Research Scientist
Supervised process characterization analytical activities from in-coming samples to out-going
data. Developed and improved assays, and coordinated assay validations. Coordinated and
conducted stability studies.
Manpower Technical (Bayer Corporation), Clayton, NC June 1998 - March 1999
Assistant Chemist, Research and Technology
Conducted assays to determine the purity, identity, and content of plasma proteins in samples.
Harnett County Schools, Angier, NC August 1997 - June1998
Teacher
Enlightened young minds to the joy of math and science by teaching six graders.
North Carolina State University, Raleigh, NC April 1997 - August1997
Research Technician III
Maintained research laboratory and performed various molecular biological techniques.
North Carolina State University, Raleigh, NC May 1996 - April 1997
Research Technician
Performed various molecular biological techniques.
EDUCATION
Received Bachelor of Science Degree in Biochemistry from North Carolina State University in
August 1996. Summa Cam Laude, Phi Beta Kappa, GPA: 3.9.