Experience

Grand River Aseptic Manufacturing

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Director Of Quality

  • Sep 2020 - Present

  Provide direction and oversight to Grand River Aseptic Manufacturing (GRAM) quality systems, including Quality Assurance, Quality Control, and Compliance functions for GRAMs clinical and commercial operations.

• Quality Assurance Sr. Manager

  • Apr 2018 - Sep 2020

  Senior Quality Assurance Manager providing leadership to Quality Assurance Managers and specialists. Responsible for the oversight and management of batch record review, raw material, in-process and finished product release process, review/assessment/approval of non-conformance reports, including deviations, laboratory / OOS investigations and environmental investigations as well as Corrective / Preventive Action (CAPA) systems. Interact with clients in support of these related systems… Show more Senior Quality Assurance Manager providing leadership to Quality Assurance Managers and specialists. Responsible for the oversight and management of batch record review, raw material, in-process and finished product release process, review/assessment/approval of non-conformance reports, including deviations, laboratory / OOS investigations and environmental investigations as well as Corrective / Preventive Action (CAPA) systems. Interact with clients in support of these related systems. Interface with auditors, including client representatives and regulatory agencies.



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Development Services Manager

  • Oct 2016 - Apr 2018

  As a Development Services Manager, I was responsible for leading the on-boarding of the Pfizer Kalamazoo site as a key site in the Pfizer CentreOne drug product contract manufacturing (CM) network, facilitating site evaluations of CM opportunities from PC1 Business Development Managers, and program management of Kalamazoo’s DP CM business portfolio, interfacing with project managers and teams to lead financial reporting and customer interface from project initiation through technology transfer,… Show more As a Development Services Manager, I was responsible for leading the on-boarding of the Pfizer Kalamazoo site as a key site in the Pfizer CentreOne drug product contract manufacturing (CM) network, facilitating site evaluations of CM opportunities from PC1 Business Development Managers, and program management of Kalamazoo’s DP CM business portfolio, interfacing with project managers and teams to lead financial reporting and customer interface from project initiation through technology transfer, process validation, submission and commercialization.

• Business Operations Lead

  • Sep 2015 - Sep 2016

  As a Business Operations Lead, I was responsible for the business operational management of the Pfizer CentreOne (PC1) Leadership Team (LT). In partnership with LT colleagues, I was responsible for the development and implementation of short and long-term PC1 business process/portfolio/resource strategy.

• Manager/TL Quality Operations

  • May 2014 - Aug 2015

  QO Manager/TL of the Non-Sterile Liquids & Semi-Solids, Biological Processing, Sterile Manufacturing and Medical Devices quality team. This team supports real time quality impact support to ensure timely release of conforming Drug Product as well as timely completion of non-conformance investigations reports with effective corrective/preventative actions.

• Mgr/TL Quality Operations

  • Feb 2013 - Apr 2014

  Mgr/TL Quality Operations for the Early Stage Testing Lab, Method Validation and Cleaning Validation Team. This team supports analytical method transfer and testing for new product introductions to the site. This team also supports all method validation activities and cleaning validation (API&DP) for the entire site.

• Manager Quality Operations

  • Nov 2011 - Jan 2013

  Led and facilitated support for product transfers (Continuous Improvement, Co-development, Site to Site, Animal Health, Human Health, Biologics) for the unit which includes QO Cleaning Validation, Analytical Method Validation, and Early Stage Testing Lab (ESTL).

• Senior Quality Operations Specialist- Technical Transfer Project Management

  • Aug 2007 - Oct 2011

  Provided QA support for over 20 projects, including Continuous Improvements, Co-Development, Site to Site Transfers and Organic Growth. Experience spanning Sterile Injectables, Liquids and Semi Solids and APIs for Human Health, Animal Health and Biologics.

• Senior Quality Operations Specialist – Plant Support

  • Jul 2006 - Aug 2007

  Conducted and reviewed non-conformance investigations related to the manufacturing, packaging and testing of product. Provided guidance and oversight in identifying root cause and preventative/corrective action. Assigned release recommendations to implicated materials. Evaluated and approved permanent changes to approved manufacturing, packaging, equipment, and test plans. Reviewd and / or approved annual product review reports. Evaluated the data associated with the annual product review… Show more Conducted and reviewed non-conformance investigations related to the manufacturing, packaging and testing of product. Provided guidance and oversight in identifying root cause and preventative/corrective action. Assigned release recommendations to implicated materials. Evaluated and approved permanent changes to approved manufacturing, packaging, equipment, and test plans. Reviewd and / or approved annual product review reports. Evaluated the data associated with the annual product review reports for trends. Accountable for review and approval of validation, qualification, and/or technology transfer deliverables (user requirements, impact assessments, plans, reports, etc.) for conformance with company procedures.

• Quality Assurance Team Leader

  • Dec 2005 - Jul 2006

  Provided direction and leadership to the Quality Assurance Specialists and Administrative Assistants. Supported transfer activities by providing batch records, analytical documents and regulatory information. Participated in site closure activities, including review of associated documents and manage resources during site closure. Executed Site Compliance Contact functions to ensure quality documentation is in compliance with corporate, regulatory and FDA regulations by acting as a liaison… Show more Provided direction and leadership to the Quality Assurance Specialists and Administrative Assistants. Supported transfer activities by providing batch records, analytical documents and regulatory information. Participated in site closure activities, including review of associated documents and manage resources during site closure. Executed Site Compliance Contact functions to ensure quality documentation is in compliance with corporate, regulatory and FDA regulations by acting as a liaison between Global Manufacturing Compliance and site. Facilitated the use of the Quality Systems approach to develop and maintain systems to assure that APIs manufactured and released meet corporate, cGMP, and legal quality requirements, and are appropriate for their intended use.

• Quality Assurance Associate

  • Jul 2001 - Nov 2005

  Executed Site Compliance Contact functions to ensure quality documentation is in compliance with corporate, regulatory, and FDA regulations by acting as a liaison between Global Manufacturing Compliance and site. Managed review and approval of Product Change Requests to ensure compliance with regulatory filings. Facilitated generation of Annual Product Reviews. Reviewed Laboratory Investigations to ensure compliance with regulatory standards, company policies, practices and processes. Audited… Show more Executed Site Compliance Contact functions to ensure quality documentation is in compliance with corporate, regulatory, and FDA regulations by acting as a liaison between Global Manufacturing Compliance and site. Managed review and approval of Product Change Requests to ensure compliance with regulatory filings. Facilitated generation of Annual Product Reviews. Reviewed Laboratory Investigations to ensure compliance with regulatory standards, company policies, practices and processes. Audited plant sites to ensure adherence to cGMPs, and conduct training to improve employee knowledge of quality regulations. Guide manufacturing personnel to resolve deviation reports and assist in defining process improvement opportunities. Primary interface with Third Party suppliers which facilitates testing, release of material and deviations.Reviewed and approved Standard Operating Procedures (SOPs) to ensure compliance with site and corporate practices. Supervised administrative personnel within department

• Analytical Chemist

  • May 1998 - Jun 2001

  Perform physical, chemical or instrumental measurements in the laboratory maintaining integrity of reagents, instrumentation, testing procedures and samples.