Anthony Onuoha
South Plainfield,NJ
Summary
A Successful Senior Quality Manager II at Bristol Myers Squibb, with over 20 years’ experience working in a regulated environment including: Cell Therapy, Pharmaceuticals, Molecular Diagnostics, Medical Device, Dietary Supplements, and Consumer Health industries, etc.
Overview
14
14
years of professional experience
Work History
Senior Quality Manager II
Celgene/ Bristol Myers Squibb
03.2021 - Current
- Manages and oversees quality events emanating from BMS Summit 12’s Manufacturing Shared Services (MSS) Value Stream that comprise of S12 Supply chain, Manufacturing Shared Services Production Organization, Contract Manufacturing Organization (Markens and Cellex facilities.), QC Incoming, Facilities and Engineering dept, and Equipment, Calibration and Qualification (ECQ), departments
- Ensure that quality events arising from these areas are effectively investigated and closed on time, with appropriate CAPA and Effectiveness checks identified and implemented
- Manages and oversee QA staff that review and approve such quality events
- Effectively oversee the training, growth, and development of my staff
- Regularly provide guidance, coaching and training as needed to my direct reports that translates into increased team efficiency, output, continuous improvement, and growth
- Contribute to the training and development of the entire QA Technical Operations deviation department staff through various technical presentations shared with the department staff
- Successfully led internal and external cross-functional teams and resolved internal and external site conflicts
- Recently, initiated and led a series of high-level meetings between QA Cell Therapy Manufacturing S12; QA External Manufacturing CTDO Patient Material; QA Global Apheresis Operations; and Global MSAT Cell Therapy Packaging Technology, that resolved multi-site disagreements emanating from handling of multi-site deviations due to Temperature Excursion quality events (with regulatory impacts) observed during Apheresis Transportation and receipt at S12
- I spearheaded and defined an acceptable path forward to handling such deviations involving multiple BMS sites
- Ensured that both global stakeholders and our MSS value stream customers and QA staff were trained on the solution articulated
- Resolved multisite conflicts arising from ownership of Marken, and/or Cellex (CMO’s) related deviations
- Successfully organized cross-functional meetings comprising of North American S12 Supply Chain Systems and Compliance
- Strategy and Business Operations (warehouse); Europe’s Scheduling & Cell Logistics
- CTDO Patient Operations Org; the Warehouse & Distribution Hub Cell Therapy Europe, and Cell Therapy Global External Manufacturing and Supply Chain Quality teams, that resulted in the following: Identification of appropriate site owners of finished Drug Product quality events observed at Marken
- Identification of appropriate site owners of quality events originating from Cellex but observed at S12
- Establishment of point contact between Europe’s Scheduling, Cell Therapy and Logistics Team (SCLT) and S12’s Warehouse/Supply Chain System and Compliance, to ensure effective transfer of information pertaining to quality events arising from BMS drug products distributed in Europe through Markens
- Establishment of point contact between S12 and Cell Therapy Global External Manufacturing and Supply Chain Quality, to ensure effective transfer of information pertaining to quality events arising from Cellex during receipt of incoming Leukapheresis, CMAT, and PBMC at S12
- Ensured that quality events arising from BMS Drug Products distributed in Europe (through Markens), and/or due to Receipt of Incoming Leukapheresis, CMAT, and PBMC from Cellex, are effectively processed following governing procedure, QMS SOP-13-2A
- BMS Business Technical Approver (BTA) of critical, major, and minor deviations that make it to the Investigation Review Board (IRB) and CAPA Review Board (CRB)
- Also, an active member of BMS IRB/CRB
- Aging Deviation Clinic: Ran the aging deviations clinic at BMS Summit site that significantly drove down the number of deviation records that have exceeded their due dates, through providing guidance and assistance to Lead Investigators, which enabled them overcome various roadblocks that originally hindered their deviation closure on-time
- QA Deviation Clinic: Actively coordinated and assisted Manufacturig Science and Technology (MSAT) deviation Investigators that walked-in to this clinic with answers that helped remove roadblocks they encountered during investigations
- Was the sitewide Owner of BMS Summit 12 Monthly trending of deviations for potential trends (Jan2023 – Apr2023) that resulted in efficient closing of deviations, identification of potential trends, opening of trend investigations that addressed potential trends, and ensured that RCA resulted in appropriate CAPA’s for them
- Prepared, coordinated, and ran cross-functional daily Breyanzi and Abecma Products Huddle meetings in 2022
- Conducted gap analysis of newly generated quality events and assigned action item owners to close identified gaps, thereby facilitating on time generation and completion of newly generated deviation records within its given lifecycle
- Ensured timely review of manufacturing and laboratory investigations of over 30 lead investigators
- Have passionately driven efficiency at BMS with bold solutions and recommendations that has ensured continuous improvement in the site’s handling of deviations
- An insightful recommendation to BMS S12’s Site Leadership Team, was implemented and it contributed to the discontinuation of a Non GMP eTriage system of deviation management, and the use of a “Deviation Sweeper” to drive efficiency
- Have successfully worked with various cross-functional teams at BMS to drive solutions that included on-time shipping of patient lots, on-time closure of deviation records, on-time mitigation plans, and on-time CAPA's
- Work with manufacturing and laboratory management to ensure investigations comply with global regulatory requirements
- Provide quality oversight to Interim Disposition Assessments and Initial Impact Assessments by Subject Matter Experts pertinent to the disposition of deviation impacted patient lots
- Participate in Material Review Board (MRB) meetings for the disposition of patient lots impacted by a deviating quality event
- Ensure that MRB decisions are effectively captured in the quality system’s electronic database prior to the disposition of a nonconforming patient lot
- Very good with the Infinity database for quality event
- Six Sigma White belt certified.
Senior Quality Investigator
Auro Packaging LLC – A Subsidiary of Aurobindo Pharma USA Inc.
07.2020 - 03.2021
- Led, conducted, wrote, reviewed, and approved quality investigations that pertained to over the counter and prescription drugs manufactured by Aurobindo Pharma USA and packaged at Auro packaging LLC
- Was in-charge of market complaint investigations, root cause analysis, correction, corrective actions, and preventive actions (CAPA)
- Responsible for maintenance of quality assurance investigation database and market complaint trend analysis, etc
- Ensured that quality investigations were completed, written, and approved in a timely manner
- Provided awareness training to Quality assurance and Packaging staff as needed.
Senior Quality Investigator
PharMeDium Health Corporation – A Subsidiary of AmerisourceBergen Corp
05.2019 - 07.2020
- Provided quality oversight to quality control laboratory and manufacturing processes
- Carried out root cause analysis investigation of laboratory and manufacturing nonconformances and/or deviations
- Identified root cause, correction, corrective actions, and preventive actions
- Oversaw their implementations
- Wrote, reviewed, and approved investigation reports
- Ensure that quality investigations are completed, written, and approved in a timely manner
- Collaborated with cross functional teams and provided guidance and resolutions to manufacturing and/ or quality control issues
- Recommended quality process improvements to increase efficiency and performance of systems, operations, and personnel and prevent recurrence of incidents or events
- Trained junior quality control and quality assurance investigators to conduct manufacturing and quality control deviation investigations
- Ensured that manufacturing instructions, standard operating procedures and pertinent quality documents identified for updates and revisions, are completed in a timely manner and implemented
- Assisted with regulatory/compliance/customer audits
- Utilized the MasterControl quality systems electronic database.
Senior Investigation Consultant (Contract Position)
Akorn Pharmaceuticals Inc
08.2018 - 04.2019
- Performed laboratory and manufacturing investigations: Out of specifications (OOS), out of trends (OOT), deviations etc
- Wrote investigation reports, generated CAPA and/or SCAR
- Reviewed investigation reports
- Coordinated, and ensured that non-conformances were adequately investigated for determination of root cause and product impact per FDA regulations
- Ensured that root causes, corrections, corrective actions, and preventive actions were effectively identified and implemented to ensure conformance, avoid recurrence and prevent occurrence
- Performed trend analysis
- Assisted with regulatory/compliance/customer audits
- Interfaced in a collaborative team environment with Manufacturing, Quality Control, Quality Assurance, Operations, Maintenance, Technical Support, and other departments to resolve quality problems
- Utilized TrackWise quality systems electronic database.
Senior Quality Engineer (Contract Position)
Zimmer Biomet (Compression Therapy Concepts)
06.2016 - 03.2017
- Remediation and integration of Compression Therapy Concept’s (CTC) Quality Management System into Zimmer-Biomet’s
- Ensured that CTC processes and procedures were in compliance with ISO13485 and 21 CFR Part 820
- Authored and executed Operation Project Plans for complaint remediation and integration
- Remediated CTC’s Complaint and Repair Processes to conform with ISO13485
- Revised/authored various Quality Standard Operating Procedures and Work Instructions, including: Good Manufacturing Practice, Complaint Handling Procedure, Return Goods Authorization (RGA) procedure and others for the company
- Trained CTC employees on the remediated procedures
- Performed quality engineering reviews of device history records to ensure compliance with stated requirements.
Quality Manager (Contract Position)
Tekni-Plex
10.2015 - 03.2016
- Oversaw the Quality Assurance/Quality Control department
- Managed QA/QC staff comprising of 3 shifts and over 15 employees
- Ensured that test procedures and product specifications were properly written, reviewed, approved, documented, and carried out in accordance with GMP
- Oversaw the review and disposition of nonconforming materials and products
- Effectively interacted with Production and Development teams to maintain product supply and launch new products
- Oversaw customer complaints, root cause analysis, corrective and preventive actions, and supplier corrective actions
- Ensured that product specifications met customer requirements
- Authored Quality Plans for customers
- Worked with purchasing staff to establish quality requirements from external suppliers
- Oversaw customer audits and responses
- Prepared Quality KPI’s for company’s management review meetings
- Utilized CompliantPro Quality electronic database.
Quality Engineer (Contract Position)
Zimmer-Biomet TMT
10.2014 - 08.2015
- Worked to remediate and address various FDA 483 observations within Zimmer corporation
- Wrote, reviewed, and approved Validation Protocols and Reports (IQ, OQ, PQ), Deviations, Investigation Reports, etc
- Led TSV TM Dental shells process improvement team and provided technical expertise as needed
- Worked with manufacturing and Quality Control to established in-process monitoring specifications for the TSV TM Dental shells line of products
- Gathered relevant information and data needed to solve quality related problems that pertained to the TSV TM Dental Shells manufacturing process.
Quality Manager
NutraBio Inc
11.2010 - 09.2014
- Oversaw the setup of an entire quality control laboratory for this company
- Hired and trained Quality Control dept
- Staff
- Wrote most of the standard operating procedures for this company and ensured that they conformed to the 21CFR Part 111 that guided the dietary supplement industry
- Scheduled and oversaw all laboratory operations for testing, review and release of raw materials, intermediates and finished products to ensure compliance with company and FDA guidelines
- Ensured that appropriate analytical methods were developed and validated for raw materials, intermediates and finished products
- Managed and oversaw the company’s approval process for suppliers and/or manufacturers of raw ingredients
- Managed, approved and oversaw external laboratories utilized by Nutrabio Inc
- As needed, for raw materials and finished products analysis
- Oversaw the review and disposition of nonconforming products
- Oversaw corrective actions and preventive actions (CAPA)
- Oversaw company’s Consumer Complaints and their documentation
- Very experienced with FDA Surveillance Audits, 483 Observations/Responses and 21 CFR Part 111.
Education
PhD Chemistry -
University of Connecticut
Skills
- Quality Assurance
- Excellent Communication & interpersonal skills
- Teamwork and Collaboration
- Quality Management
- Leadership and team management
- Strong Organizational Skills
- Employee training & Supervision
- Time management
- Problem Solving & Critical thinking
- CAPA
- Continuous Improvement
- Regulatory Compliance
- Product quality
- Attention to details
- Customer service
- Documentation
- Strong Work Ethic
- Multitasking
- Decision-Making
- Relationship Building
- Team building
- Task Prioritization
Patents & Publications
Available on Request
References
Available on Request
Timeline
Senior Quality Manager II
Celgene/ Bristol Myers Squibb
03.2021 - Current
Senior Quality Investigator
Auro Packaging LLC – A Subsidiary of Aurobindo Pharma USA Inc.
07.2020 - 03.2021
Senior Quality Investigator
PharMeDium Health Corporation – A Subsidiary of AmerisourceBergen Corp
05.2019 - 07.2020
Senior Investigation Consultant (Contract Position)
Akorn Pharmaceuticals Inc
08.2018 - 04.2019
Senior Quality Engineer (Contract Position)
Zimmer Biomet (Compression Therapy Concepts)
06.2016 - 03.2017
Quality Manager (Contract Position)
Tekni-Plex
10.2015 - 03.2016
Quality Engineer (Contract Position)
Zimmer-Biomet TMT
10.2014 - 08.2015
Quality Manager
NutraBio Inc
11.2010 - 09.2014
PhD Chemistry -
University of Connecticut
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