Bruce Wallace Email & Phone Number

Auckland, New Zealand

Auckland, 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.

Auckland, 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.
• 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.

Auckland, 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.

West 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.

West 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

West 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.
• 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.

West 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.

West 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.

West 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.

West 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.
• Performed internal safety and cGMP audits.

Greater Philadelphia Area

Avondale, Pennsylvania, USA