Karen N. Ryan
Elmwood Park,USA
Summary
Experienced professional in regulated manufacturing of clinical and commercial sterile fill and solid dosage drug products, as well as combination products. Demonstrated success in applying quality systems-based initiatives and innovation to drive performance as both an independent contributor and team leader. Expert knowledge of cGMP, CFR, EU, and other global requirements within biopharmaceutical manufacturing. Strong interpersonal and written communication skills, coupled with proficiency in a wide range of software tools and learning management systems.
Overview
40
40
years of professional experience
1
1
Certification
Work History
Sr. Director, Commercial Quality
Capstone Development Services/LG Pharmaceuticals
07.2024 - Current
- Responsible for the development, implementation, and management of Capstone’s internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance. Responsible for collaboration with Technical Operations, Product Development, Supply Chain, Regulatory Affairs and Clinical Operations to provide oversight of quality matters related to the manufacturing, testing, and release of commercial products.
- Acts as the company authority for the interpretation of global GMP regulations and guidance documents related to pharmaceutical drug substance and drug product manufacturing
- Quality Subject Matter Expert on sterile injectable drug product and combination drug product manufactured in US, EU, India, Taiwan and exported/imported to US
- Acts as primary spokesperson to all third parties on quality and compliance issues including regulatory agencies, corporate alliance partners, CMOs, CDMOs, and suppliers
- Responsible for setting quality policy and approving GMP standards, including policies, procedures, analytical methods, product specifications, master batch records, raw material and API specifications, and validation documents
- Responsible for the disposition of commercial drug product
- Responsible for the design, management and continuous improvement of all quality systems including change control, deviations, CAPA, complaint handling, returned goods, vendor management and supplier quality, quality agreements, document/records control, and archive, and GMP training
- Responsible for QA oversight and approval of validation protocols, programs, and reports for the process, cleaning, equipment, analytical methods, shipping, and computerized systems
Manager, Commercial Quality
Xellia Pharmaceuticals
10.2023 - 07.2024
- Responsible for the development, implementation and improvement of Quality Management Systems for the Xellia US Commercial Organization.
- Provide key support for Product Release, Good Distribution Practice systems, Product Complaints, and most marketing approval commitments. Responsible for the development, implementation, and management of Xellia’s internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance. Responsible for collaboration with Business Development, Supply Chain, Regulatory Affairs and Medical Affairs to provide oversight of quality matters related to the manufacturing, testing, and release of commercial products.
Vice President, Global, Quality Assurance
Athenex Inc.
02.2021 - 05.2023
- Responsible for the development, implementation, and management of Athenex’s internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance. Responsible for collaboration with Business Development, Supply Chain, Regulatory Affairs and Clinical Operations to provide oversight of quality matters related to the manufacturing, testing, and release of Clinical Trial Materials (CTM) and commercial products.
- Acts as the company authority for the interpretation of global GMP regulations and guidance documents related to pharmaceutical drug substance and drug product manufacturing
- Quality Subject Matter Expert on sterile injectable drug product, 503B compounded drug product, ointment, and oral drug product manufactured in US, EU, China, India, Taiwan and exported/imported to US and multiple countries including UK, Germany, and Switzerland
- Acts as primary spokesperson to all third parties on quality and compliance issues including regulatory agencies, corporate alliance partners, CMOs, CDMOs, and suppliers
- Responsible for setting quality policy and approving GMP standards, including policies, procedures, analytical methods, product specifications, master batch records, raw material and API specifications, and validation documents
- Responsible for the disposition of commercial and clinical drug product
- Responsible for the design, management and continuous improvement of all quality systems including change control, deviations/investigations, CAPA, complaint handling, returned goods, vendor management and supplier quality, quality agreements, document/records control, and archive, and GMP training
- Responsible for QA oversight and approval of validation protocols, programs, and reports for the process, cleaning, equipment, analytical methods, shipping, and computerized systems
Executive Director, Quality Assurance
Assertio Therapeutics, Inc.
08.2020 - 02.2021
- Responsible for the development, implementation, and management of Assertio’s internal and external quality strategy, and Quality Assurance (QA) systems to achieve compliance with company standards, cGMP, FDA regulations and guidance. Responsible for collaboration with Contract Manufacturing, Supply Chain, Regulatory Affairs and Clinical Operations to provide oversight of quality matters related to the manufacturing, testing, and release of Clinical Trial Materials (CTM) and commercial products.
- Acts as the company authority for the interpretation of GMP regulations and guidance documents related to pharmaceutical drug substance and drug product manufacturing
- Acts as primary spokesperson to all third parties on quality and compliance issues including regulatory agencies, corporate alliance partners, CMOs, and suppliers
- Responsible for setting quality policy and approving GMP standards, including policies, procedures, analytical methods, product specifications, master batch records, raw material and API specifications, and validation documents
- Responsible for the disposition of commercial and clinical drug product
- Responsible for the design, management and continuous improvement of all quality systems including change control, deviations/investigations, CAPA, complaint handling, returned goods, vendor management, quality agreements, document/records control and archive, and GMP training
- Responsible for QA oversight and approval of validation protocols, programs, and reports for the process, cleaning, equipment, analytical methods, shipping, and computerized systems
- Manages internal and external audit programs for all GXP activities including CMOs, CDMOs and CROs
Sr. Director, Alliance Management
NantBio Inc.
04.2017 - 06.2018
- Responsible for collaborating with Manufacturing Operations, Product Development, Quality Assurance, Regulatory Affairs, and Legal to identify and qualify new Contract Service Providers (CSP) and to maintain relationships with existing Contract Service Providers (CSP) in the areas of API, Drug Substance, and Drug Product manufacturing, testing, storage, and distribution.
- Acted as primary contact to Contract Service Providers (CSP) for manufacturing, testing, storage, and distribution of Investigational Drug Product
- Directed the Contract Manufacturing system to ensure documentation including confidentiality agreements, manufacturing and testing agreements and quality technical agreements are executed in a compliant and timely manner
- Provided support for NantWorks audit teams as the Subject Matter Expert in audits of existing CSPs and potential CSPs
- Provided technical support for internal manufacturing of Clinical Drug Product by ensuring appropriate implementation of change controls, equipment and area qualifications, Master Batch Records, and SOPs. Also directs investigations of deviations to determine root cause and appropriate CAPA.
- Provided support for internal storage and distribution operations of Investigational Drug Product by reviewing and approving documentation including SOPs, investigations related to temperature excursions during shipping, and technical reports supporting extension of expiration periods based on stability data
- Participated as Subject Matter Expert on Acquisition and Integration teams
Director, Quality Operations
Celgene Corporation
10.2014 - 03.2017
- Responsible for collaborating with Technical Operations to identify and qualify new Contract Service Providers (CSP) and responsible for directing oversight of Vendor Quality Managers (VQM) responsible for management of existing Celgene CSPs.
- Directed the Vendor Quality Management system to ensure Change Controls, Investigations, Deviations, Customer Complaints, CAPAs, and other related documentation related to CSPs is managed in a compliant and timely manner
- Provided support for Celgene audit teams as the SME in audits of CSPs and potential CSPs
- Provided direction for authoring and maintenance of Quality Technical Agreements with Celgene CSPs
- Responsible for oversight of API and drug product batch record review and disposition for commercial products manufactured in the Americas
- Managed, hosted, and facilitated Health Authority inspections and internal audits. Responsible for generating responses for Health Authority Inspections and internal audits. Interacted with HA officials to convey the compliance level of quality systems during inspections and through direct communication with HA officials. Provided support as needed for CSP Health Authority Inspections
- Generated and approved Field Alert, Recall and other regulatory notifications for submission to applicable Health Authorities.
- Performed Quality Operations review and approval for internal change controls, deviations, customer complaints, CAPAs, and documentation changes
- Supported RA CMC requests for site documentation to be included in Regulatory Authority product submissions and coordinated site SME review of Regulatory Authority product submissions to ensure filing timelines were met
- Managed and coordinated site Management Review meetings. Supported Management Review process, APR/PQR compilation, and implementation of global policy requirements
- Executed gap analysis assessments to ensure evaluation of key site functions are in compliance with regulatory requirements
- Maintained current knowledge of industry standards as it applies to cGMPs and global regulatory requirements
Director, QA/QC
Celgene Corporation
06.2012 - 10.2014
- Responsible for Quality Assurance Oversight (Vendor Quality Management) of contract manufacturing and testing operations for aseptically filled, sterile injectable drug product.
- Administered Management Review and Annual Product Quality Review system
- Provided direction of quality assurance personnel including the following functions: batch review and disposition, deviation/complaint/OOS/OOT/field alert/recall authoring/review/approval, hosting of regulatory inspections, writing and reviewing responses to regulatory agency observations, and participation in the External Audit program
- Responsible for contract testing operations at external laboratories located in the EU and management of relationships with marketing partners and affiliates located in Japan, Australia, Canada, China, and India
- Responsible for management of relationships with API and excipient suppliers for key proprietary product
- Recognized and resolved documentation discrepancies per GMP and company policies
Director, Quality Operations
Celgene Corporation
10.2010 - 06.2012
- Responsible for Quality Control and Quality Assurance Oversight of multiple internal and contract manufacturing facilities.
- Administered Management review and Annual Product Quality Review system
- Directed Quality Assurance and Quality Control personnel including the following functions: batch documentation issuance, Quality Control testing for raw materials and in-process/finished product, raw material/in-process/finished product batch review and disposition
- Responsible for oversight of the metrology, calibration and validation activities for commercial Quality Control and Product Development laboratories
- Responsible for oversight of deviation, complaint, Field Alert, and recall documentation authoring/review/approval
- Responsible for hosting regulatory inspections, writing, and reviewing responses to regulatory agency observations, participation in the Internal/External Audit program, and quality oversight of contract manufacturing operations
- Recognized and resolved documentation discrepancies per GMP and company policies
Director, Quality Operations
Abraxis Bioscience, LLC
04.2010 - 10.2010
- Responsible for Quality Control and Quality Assurance Oversight of multiple manufacturing facilities.
- Administered Management Review and Annual Product Review system
- Directed Quality Assurance and Quality Control personnel including the following functions: batch documentation issuance, Quality Control testing for raw materials and in-process/finished product, raw material/in-process/finished product batch review and disposition, metrology, calibration and validation activities for commercial Quality Control and Product Development laboratories
- Responsible for oversight of deviation, complaint, Field Alert, and recall documentation authoring/review/approval
- Responsible for hosting regulatory inspections, writing, and reviewing responses to regulatory agency observations, participation in the Internal/External Audit program and quality oversight of internal and contract manufacturing operations
Associate Director, Quality Assurance
Abraxis Bioscience, LLC
12.2007 - 04.2010
- Responsible for Quality Assurance Oversight of multiple manufacturing facilities, administration of Internal and External auditing programs, and Global Quality Assurance oversight.
- Responsible for batch disposition, deviation/complaint/recall review/approval, and launch of key proprietary product in global markets
- Responsible for hosting and managing multiple regulatory inspections (FDA, EMEA, PMDA, GCC).
- Responsible for writing and reviewing responses to regulatory agency observations
- Responsible for administration of the Internal and External Audit programs
- Responsible for Quality oversight of internal and contract manufacturing operations
Global Nanotechnology Program Quality Manager
Abraxis Bioscience, LLC
11.2006 - 12.2007
- Responsible for overseeing multiple activities related to approval and launch of key proprietary product in global markets including EU, India, Japan, Australia, China, and Korea.
- Authored and reviewed Quality Technical Agreements, prepared for and coordinated EMEA pre-approval inspection for key proprietary product resulting in EU approval
- Participated on cross functional team resulting in successful launch of Abraxane in EU, India, Japan, Australia, China, Korea, and Russia
- Performed change control assessment of internal SOPs against global GMPs to ensure compliance to global regulations
- Authored, reviewed, and submitted responses to regulatory authority inspection observations
Manager, Quality Operations
American Pharmaceutical Partners
02.2002 - 11.2006
- Responsible for Quality Assurance Oversight of Aseptic Manufacturing facility operations for approximately 150 finished product codes.
- Responsible for manufacturing deviation/complaint review/approval, participation in regulatory inspections and internal/external audits, review/approval of equipment and document change controls, review/approval of equipment and process validations, and review/approval of QC Chemistry and Microbiology OOT, OOS, and deviation investigations
- Responsible for Incoming QC testing of components (vials, stoppers, seals, labeling material, supply items) and sampling of chemical raw materials
- Supported implementation of enterprise wide TrackWise, SAP, and Documentum systems
Supervisor, QC Chemistry
American Pharmaceutical Partners
06.1996 - 02.2002
- Responsible for oversight of QC Chemistry raw material testing.
- Supervised chemists performing compendia testing of API/Excipients to support manufacturing of approximately 150 finished product codes
- Provided review/approval of QC Chemistry OOS and deviation investigations
- Supported manufacturing plant WFI and Medical Air utility testing to meet USP requirements
Supervisor, Quality Assurance
Fujisawa
01.1989 - 01.1996
- Responsible for oversight of manufacturing Quality Assurance operations
- Supervised QA specialists responsible for daily auditing of manufacturing operations including formulation, component preparation, aseptic filling, lyophilization, crimping, visual inspection, and packaging for approximately 150 finished product codes
- Responsible for resolution of manufacturing quality issues and review/approval of manufacturing deviations
- Responsible for investigation and approval of product quality complaints
- Responsible for review and approval of equipment/document change control and quality oversight of facility/utility operations
Research and Development Scientist
Lyphomed
01.1987 - 01.1989
- Developed formulation processes to support abbreviated new drug product application regulatory submissions
Wholesale Operations Associate
Lyphomed
01.1986 - 01.1987
- Processed wholesaler chargeback credits
Education
Bachelor of Science - Biology
University of Illinois at Urbana-Champaign
Skills
- Collaborative leadership
- Culture transformation
- Team management
- Policy development
Affiliations
- 6/4/1994–Current Member-American Society for Quality (ASQ)
- Member-PDA
Certification
8/1982–5/1986 Certified Quality Engineer (CQE) American Society for Quality (ASQ) Milwaukee, WI
Timeline
Sr. Director, Commercial Quality
Capstone Development Services/LG Pharmaceuticals
07.2024 - Current
Manager, Commercial Quality
Xellia Pharmaceuticals
10.2023 - 07.2024
Vice President, Global, Quality Assurance
Athenex Inc.
02.2021 - 05.2023
Executive Director, Quality Assurance
Assertio Therapeutics, Inc.
08.2020 - 02.2021
Sr. Director, Alliance Management
NantBio Inc.
04.2017 - 06.2018
Director, Quality Operations
Celgene Corporation
10.2014 - 03.2017
Director, QA/QC
Celgene Corporation
06.2012 - 10.2014
Director, Quality Operations
Celgene Corporation
10.2010 - 06.2012
Director, Quality Operations
Abraxis Bioscience, LLC
04.2010 - 10.2010
Associate Director, Quality Assurance
Abraxis Bioscience, LLC
12.2007 - 04.2010
Global Nanotechnology Program Quality Manager
Abraxis Bioscience, LLC
11.2006 - 12.2007
Manager, Quality Operations
American Pharmaceutical Partners
02.2002 - 11.2006
Supervisor, QC Chemistry
American Pharmaceutical Partners
06.1996 - 02.2002
Supervisor, Quality Assurance
Fujisawa
01.1989 - 01.1996
Research and Development Scientist
Lyphomed
01.1987 - 01.1989
Wholesale Operations Associate
Lyphomed
01.1986 - 01.1987
Bachelor of Science - Biology
University of Illinois at Urbana-Champaign
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