|Desired Industry: Biotech
|Desired Job Location: Loveland, Colorado
||Date Posted: 3/12/2008
|Type of Position: Full-Time Permanent
||Availability Date: 3/15/08
|Desired Wage: 120000
||U.S. Work Authorization: Yes
|Job Level: Management (Manager, Director)
||Willing to Travel: Yes, 25-50%
|Highest Degree Attained: MBA
||Willing to Relocate: Undecided
Technically sophisticated and business-savvy management professional with a career reflecting strong leadership qualifications coupled with “hands-on” quality control expertise. Maintain focus on achieving bottom-line results while formulating and implementing business solutions to meet a diversity of needs. Superior record of delivering simultaneous mission-critical projects on time and under budget. Influential team-based leader with intrinsic talent for conceptualizing and communicating vision, empowering, management and fostering consensus and cohesion for achievement of common goals.
Amgen Inc. – Longmont, CO
2006-Pres Senior Specialist QA
Successful quality experience as it relates to quality systems integrating FDA, ICH, GMPs, . Good understanding of Regulatory and Quality requirements related to the pharmaceutical/biological industry.
• Interface with senior management to set regulatory and quality policies with emphasis on quality/product quality and with adherence to governmental standards.
• Pivotal leadership role in promoting, executing and establishing the company’s Quality and Regulatory strategies in accordance with the established Quality plan.
• Provide strategic as well as tactical/day to day management in the areas of quality control, quality assurance, and compliance.
• Key cross-functional liaison role with Quality Assurance, Facilities/Equipment, Production, Materials Control, Laboratory Controls.
• System Owner for the site Change Control process
• Represent the site during regulatory inspections.
Eli Lilly and Company - Indianapolis, IN 1998-2006
Global Quality Control Representative
Managing Global Data Steward for the Global Business Integration Process (GBIP) involving Corporate Good Manufacturing Practice (GMP) applications related to SAP implementation across the company. Primary roles include the Global QM Master Data Steward for the GBIP Solution as well as providing QC oversight for the Materials Master Data business processes in SAP. Ensure trained, aligned staff at appropriate staffing level, Set departmental strategy and objectives, Create annual audit plan for units within area of responsibility, Review and approve audit and assessment reports and summaries, Provide advice on the interpretations of corporate, GMP and regulatory requirements. Maintain efficient communications to relevant groups within the company and with appropriate outside organizations. To participate as required in teams, committees or other groups or individually to achieve the departmental, site or company goals. Review and approve divisional and corporate quality procedures as needed. Be continually aware of current industry trends. Participate in projects as directed that support or enhance QA or larger quality organizations’ ability to carry out mission and meet objectives. Human resource development and planning including active resolution of HR issues, creation/review of employees’ performance plans, and participation in relative contribution discussion sessions.
WLS Enterprises - Indianapolis, IN 2002-2003
Director of Technical Services
Senior consultant for a start-up chemical distribution company on a series of leading-edge engagements, working in collaboration with diverse clients in a broad range of industries from Global 1000 companies to start ups in pharmaceutical and health and beauty care products.
ATC Environmental Services – Indianapolis, IN. 1995-1998
Laboratory Supervisor/Training manager
Utilized by management as a mentor/trainer for new members of the department, including leadership. Developed training materials for new employees. Often consulted for guidance by other members of the group, to provide coaching and mentoring regarding inspections and preparation. Provided technical understanding of the regulations applicable to laboratory testing for EPA purposes.
Military Service - United States Marine Corp Res. 1988-1999
Highest rank attained: Chief Warrant Officer 2 (CWO2)
Responsibilities included general oversight for the safety, training, and wellbeing of Marines under my area of command as well as the maintenance and availability of $MM motor transport equipment.
Bachelor of Science, Biology
Bachelor of Arts, Chemistry
Indiana University/Purdue University at Indianapolis, IN
Masters of Business Administration
University of Phoenix, Indianapolis
1st year law student Concord University
Areas of Expertise
General Operations Management, Regulatory Compliance, Team Building & Leadership, Continuous process Improvement, Change Management, Project Management, Supply Chain Management, Productivity Enhancement, HR Development & Training
• Interviewed and recruited associates; direct reports located at multiple sites and globally, created empowering and collaborative work environment including numerous committees and shared decision-making protocols.
• Championed investigation into sampling schemes to improve process efficiency. The Mean Time Between Failure (MTBF) for acceptance criteria was determined. Recommended and managed a change for a new sampling strategy the cycle time savings equivalent to an additional potential cash flow of $591,840 per annum expressed as drug product sales, as well as gain per lot increased throughput of 60 hours of production capacity.
• Piloted a Team in a second and third tier analysis of procedural deviations. The top three reoccurring root cause incidents were monitored daily to predict possible compliance failure. For each category, the root causes of the incidents were identified and corrective actions implemented. This resulted in an 85% reduction in the number of deviations from procedure.
• Lead inspectors for the division in QC laboratory inspections. Action included reviewing items ready for the inspection then physically inspecting the laboratories for compliance to procedures. These included: list of all equipment in lab, list of all analytical methods, Departmental Signature Log and Organization Chart, copies of training, list of Out of Specification investigations, list of reference standards and local reference standards, media preparation and growth promotion testing procedure, maintenance and calibration information for sterility testing and stability sample failures. Findings were documented, referenced to the appropriate procedures. Was able to influenced changes on a global level based on compliance gaps in equipment files, Job Aids and documentation practices.
• Drove changes to method revisions that were neither current nor accurate. Critically scrutinized laboratory SOP's to define what could and could not be done with particular approaches, techniques, methods or procedures. I delegated review of procedures to include appropriate Scientist’s and Leaders. Based on the determinations the tasks were prioritized and included in the divisional GMP improvement plan that was submitted to the FDA.
• Instrumental player in project management in the planning and execution of a new plant site in Puerto Rico. Overhauled methods for manufacturing by comparing method specs, method codes and method descriptions to the Regulatory Commitment Document and USP monograph or applicable general chapters. Gaps in method validations were identified. Method validation protocols were written, reviewed and approved. Co-validated 6 analytical methods consistent with ICH guidelines. Coordinated efforts with corporate Regulatory, QC and Technical Services. Change Control was initiated and followed to completion. Validated methods are being transferred to the PR05 plant site in 2003 on schedule and within budget.
• Prepare for all regulatory inspections by monitoring self-inspection results, facilitate resolution of resulting issues, develop, implement compliance improvement initiatives (e.g., deviation reduction measures), provide metrics and ensure representation on Quality Lead Teams.
Available upon request.
Candidate Contact Information:
|JobSpider.com has chosen not to make contact information available on this page.
Click "Contact Candidate" to send this candidate a response.