Bruce Wallace Email and Phone Number
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A Quality Assurance professional with significant experience in the human/veterinary pharmaceutical industry and a passion for working with people to develop quality solutions that allow organisations to thrive.Key Skills:● Development and management of cGMP pharmaceutical quality systems, quality assurance, quality control, supplier management, root cause analysis, risk assessment and inspection management● Pharmaceutical manufacturing● Strong focus on developing leadership and performance● Auditing● Technology transfer● Contract manufacturing● Proficient in a variety of ERP and eQMS systemsMy approach to quality is summarised in a quote from Antarctic explorer Roald Amundsen, "Victory awaits him who has everything in order — luck, people call it. Defeat is certain for him who has neglected to take the necessary precautions in time; this is called bad luck.”I take quality and patient safety very seriously, but that doesn’t mean I take myself so seriously. I relocated from the US in 2009 for the outdoor lifestyle and now call New Zealand my home. When I’m not at work, I like hiking with my wife, gardening and traveling.
Helius Therapeutics
View- Website:
- helius.co.nz
- Employees:
- 19
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Chief Quality OfficerHelius Therapeutics Jan 2020 - PresentAuckland, New Zealand
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Global Head Of QualityArgenta Manufacturing Ltd. Mar 2017 - Jan 2020Auckland, New Zealand● Responsible for the oversight of quality functions at Argenta’s three manufacturing sites (UK, NZ, USA)● Development and ownership of Argenta’s global quality systems● Management of client quality relationships● Point of contact to regulatory agencies for GMP compliance and quality mattersKey Achievements● The Quality team hosted FDA inspections at each of Argenta’s global sites with zero 483 observations issued.● Supported US-based Argenta Quality team to hire staff, build quality systems and host a successful FDA inspection (no 483 observations) within 4 months of purchasing site.● Conducted EU GMP readiness audit of US site to prepare for EMA inspection, resulting in successful issuance of GMP certificate. -
Head Of QualityArgenta Manufacturing Ltd. Jan 2012 - Mar 2017Auckland, New Zealand● Responsible for all Quality functions at the Argenta NZ site including Quality Assurance, Quality Control, Document Control, R&D Compliance and Laboratory Services.● Responsible for quality systems, cGMP compliance and maintaining accreditations with necessary regulatory agencies to allow export to over 40 global markets. ● Directly led Quality Assurance, Document Control and R&D Compliance departments from 2012 to 2016Key Achievements:Successfully hosted 3 FDA inspections, 4 ACVM inspections and more than 25 GMP audits from major multinational pharmaceutical companies. ● Dramatically reduced numbers of manufacturing deviations through focus on strong CAPAs and ownership of quality standards within operations areas.● Successfully hosted MedSafe GMP inspection to support the supply of human clinical trial materials.● Participated in successful Ministry of Health inspection to support Argenta’s license for handling Class B controlled drugs.
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R&D Compliance OfficerArgenta Manufacturing Ltd. Feb 2009 - Dec 2011Auckland, New Zealand● Responsible for quality oversight of R&D group ensuring that products and data used for regulatory submission and clinical trials were of appropriate GMP standards.● Developed a quality management system for R&D that combined a “fit-for-purpose” level of stringency with the agility and flexibility to meet critical product development timelines.
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Gmp Compliance AssociateMerck Jun 2005 - May 2007West Point, Pennsylvania, Usa● Provided support and guidance to Global Clinical Supply Operations (GCSO) to ensure GMP compliance and timely release of clinical study supplies.● Reviewed clinical supplies packaging and shipping documentation for cGMP compliance and blinding of supplies.● Responsible for release of clinical supplies for use in trials.● Performed inspections of GCSO production areas and external contract vendors to ensure cGMP compliance.● Conducted complaint investigations registered against clinical supplies.● Trained new GMP Quality employees in the review of clinical packaging/shipping documents as well as the clinical complaint investigation process.● Authored and revised several SOPs to support roll-out of Merck’s Enterprise Resource Planning Clinical Supplies Operations (ERPCSO) system. -
Quality Assurance AnalystMerck Oct 2003 - Jun 2005West Point, Pennsylvania, Usa● Lead investigator for Product Quality Complaints (PQC) and Adverse Experience Reports (AER) registered against vaccine and sterile pharmaceutical products.● Proofed biological PQC investigations to ensure accuracy of information. Provided monthly complaint trends to Vaccine and Sterile operations senior management.● Coordinated and led monthly Vaccine Operations complaint meetings.● Provided complaint data as well as direct support for inspections by the EMEA Dutch Inspectorate and the FDA Team Bio inspections, both of which resulted in zero observations
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Quality Assurance InvestigatorMerck Oct 2002 - Oct 2003West Point, Pennsylvania, Usa● Conducted PQC and AER investigations for vaccine and sterile pharmaceutical products.● Investigations include review of manufacturing, sterile filling, lyophilization and packaging documents, market control retention samples, laboratory release testing data, quarantines and Atypical Process Reports (APRs), as well as submission of samples for laboratory testing.● Conducted direct teleconferences with customers, healthcare professionals and other complainants to gather complaint information, and to provide product education, when appropriate● As part of Polysaccharide Production, coordinated, documented, and tracked process-specific, cGMP and safety training, including the delivery of new employee orientations.● Maintained departmental training and safety records such that they were organized, cGMP compliant, and inspection-ready at all times.
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Training CoordinatorMerck Mar 2002 - Oct 2003West Point, Pennsylvania, Usa● Supervised three shifts of biotechnicians and general workers.● Scheduled and oversaw daily production activities, authored deviations and completed corrective actions.● Performed document review of vaccine manufacturing records to ensure cGMP compliance. ● Conducted documentation and facility readiness audits prior to FDA PAI inspection, resulting in zero “483” observations.
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Production SupervisorMerck Jan 2001 - Feb 2002West Point, Pennsylvania, Usa● Provided technical support to biotechnicians producing the PNEUMOVAX®23 vaccine.● Reviewed manufacturing documentation for cGMP compliance. Authored deviations and completed corrective actions. Revised downstream SOPs.● Completed inventory and financial management transactions in IMPACT ERP system.
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Associate Production SupervisorMerck Apr 2000 - Dec 2000West Point, Pennsylvania, Usa● Provided technical support to biotechnicians producing the PNEUMOVAX®23 vaccine.● Reviewed manufacturing documentation for cGMP compliance. Authored deviations and completed corrective actions. Revised downstream SOPs.● Completed inventory and financial management transactions in IMPACT ERP system.
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BiotechnicianMerck Jun 1999 - Mar 2000West Point, Pennsylvania, Usa● Carried out activities associated with the production of the Polysaccharide powder component of the PNEUMOVAX®23 vaccine in strict accordance with SOPs and MPDs. Activities included, CIP/SIP of production vessels, media and buffer preparation, aseptic equipment assembly, fermentation, recovery, and purification of batch material.● Performed internal safety and cGMP audits.
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Participation Program ManagerLandmark Education Corporation Jul 1998 - Jun 1999Greater Philadelphia Area -
Staff ScientistStroud Water Research Center Aug 1995 - Jul 1998Avondale, Pennsylvania, Usa
Bruce Wallace Skills
Bruce Wallace Education Details
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Biology, General
Frequently Asked Questions about Bruce Wallace
What company does Bruce Wallace work for?
Bruce Wallace works for Helius Therapeutics
What is Bruce Wallace's role at the current company?
Bruce Wallace's current role is Chief Quality Officer at Helius Therapeutics.
What is Bruce Wallace's email address?
Bruce Wallace's email address is br****@****a.co.nz
What schools did Bruce Wallace attend?
Bruce Wallace attended Gettysburg College.
What skills is Bruce Wallace known for?
Bruce Wallace has skills like Fda Gmp, Root Cause Analysis, Pharmaceutical Industry, Quality Assurance, Gmp, Standard Operating Procedure, Good Laboratory Practice, Validation, Technology Transfer, Quality System, U.s. Food And Drug Administration, Corrective And Preventive Action.
Who are Bruce Wallace's colleagues?
Bruce Wallace's colleagues are Caleb Wigman, Shweta Vagal, Hon Man Adrian Lau, Matthew Byerly, Bethany Reade, Hardy Susanto, Stephen Landkroon.
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