Jeff Brenneman

About Jeff Brenneman

Pharmaceutical-industry professional with 28 years’ experience in solid and liquid oral dose manufacturing of branded, generic, and OTC products. My career has focused on operations, quality assurance, and quality control. Implemented processes to reduce error rates at several sites by implementing investigation and root cause training, metrics, and performance recognition while maintaining data integrity. Reduced laboratory turnaround time and increased schedule attainment with focused scheduling controls and weekly metrics. Improved employee performance through leadership style, accountability, and feedback mechanisms. Implemented robust quality systems, training, and culture to maintain compliant operations and reliable deliveries of quality products.

Experience

1. Vice President, Global Operations Quality

   Alora Pharmaceuticals, LLC

   May 2022 — Present · Marietta, GA, US

   Vice President, Global Operations Quality for Alora Pharmaceuticals family of companies, with quality oversight of Alliant Packaging in Alpharetta, GA, Osmotica Pharmaceuticals in Marietta, GA, Trigen Laboratories in Tampa, FL, Vertical Pharmaceuticals in Sayreville, NJ, and Sovereign Pharmaceuticals in Fort Worth, TX. Reporting to me are the site quality directors of each manufacturing location, as well as the Head of Third Party Quality (CMO oversight), and Associate Director, Quality Process Excellence. Provide strategy and guidance to implement, manage, and improve quality programs per 21 CFR 210, 211 and ICH Q9 / Q10. Champion quality operations improvement processes to ensure product quality and adherence to CGMPs. Hire and manage quality operations leadership, define expectations, and coordinate priorities across multiple projects and site activities. The activities of my role and my team include:· Re-organized corporate quality structure and site leadership teams to streamline quality processes· Implemented corporate quality policies that apply to the entire network to ensure global compliance· Won new drug product business for Osmotica/Trigen sites due to reliable deliveries and product quality· Currently implementing MasterControl QMS for Sovereign and Alliant sites to improve event quality· Currently supporting implementation of SAP for improved product management and process optimization· Implemented batch record review certification program to ensure high quality review across the network· Implemented on-time quality review for product release throughout the network for reliable deliveries· Created position and hired the Associate Director, Quality Process Excellence to lead lean improvements· Quality Process Excellence activities currently involve 5S improvements and tracking quality initiatives

Education

• Southeast Community College

  Associates, Laboratory Science and Technology

  2003 — 2004

• University of Nebraska-Lincoln

  BS, Biochemistry

  2005 — 2007

Skills

• Change Control
• Raw Materials
• Gxp
• Equipment Qualification
• Quality Auditing
• Cleaning Validation
• Cgmp Practices
• Quality System
• V&V
• Dissolution
• Deviations
• Cgmp Manufacturing
• Standard Operating Procedure (Sop)
• Analytical Method Validation
• Pharmaceutical Industry
• Sop
• Deviation Management
• Fda
• Wet Chemistry
• Chromatography
• Team Leadership
• Gas Chromatography
• Computer System Validation
• Quality Assurance
• R&D
• Quality Control
• Gmp
• Software Documentation
• Qaqc
• Root Cause Analysis
• Root Cause Problem Solving
• Capa
• Pharmaceutical Manufacturing
• Fda Gmp
• Sop Development
• Lims
• Impact Assessment
• Regulatory Requirements
• Glp
• Usp