Robert Benda Email & Phone Number

South San Francisco, California, Us

Lead the management of Star Therapeutics and its affiliates quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations (GxP) by developing systems, processes and conducting audits of projects, processes, and vendors.

Los Angeles, Ca, Us

Primary Objective of PositionThe Senior Director, Commercial Quality Assurance will lead the Commercial Quality Assurance function at Puma Biotechnology. This individual will be responsible for building and managing a Commercial Quality Assurance group to oversee all quality aspects of commercial drug manufacturing for Puma, including release of all manufactured drug substance and drug products lots, and quality oversight of work performed by Puma’s Contract Manufacturing Organizations (CMO), while ensuring timely delivery of quality products and services.The Senior Director, Commercial Quality Assurance will develop quality strategy and operations processes in compliance with Good Manufacturing Practice (GMP) and applicable regulations and guidance. This individual will also create and implement quality systems required to manage, control, and keep track of the commercial quality processes.

Calabasas, Ca, Us

• Develop and lead implementation and monitoring of company-wide quality system based on US FDA regulations and international standards such as ISO.• Implement and monitor effective and efficient quality document management process for timely processing of document changes and distribution of quality information.• Implement and monitor internal and supplier audit programs to ensure compliance with quality system requirements.• Conduct audits to identify non-compliance in adherence to SOPs, regulations, and GxPs Provide GCP/QA consultation to all staff • Lead and implement an effective Corrective and Preventive Action (CAPA) program as a part of continuous improvement.• Act as a company liaison during customer and regulatory quality and qualification audits. Ensure any corrective and preventive actions during external audits are communicated and implemented in a timely manner.• Arrange and coordinate management review meetings by presenting quality data with actionable information for continuous improvement and achievement of quality objectives. • Act as a management representative for quality system and ensure that quality policy and quality objectives are communicated and achieved in a timely manner.• Drive accountability and continuous improvement through training, SOPs, and workflows as needed to proactively improve quality, efficiency, and standardization.• Manage, hire, train, motivate, and develop team members in the quality organization with a positive focus on continuous improvement for their growth within the organization.• Apply technical knowledge, scientific experience and expert judgment to a broad range of difficult problems to develop effective and efficient solutions in a timely manner.

Boston, Ma, Us

● Assures that the upstream and downstream supply chain is compliant with all relevant FDA and EMA regulations regarding critical supplies, GMP equipment, and vendor activities associated with product distribution.● Maintains an audit schedule of vendors and conducts periodic audits of their facilities to insure a capability to provide an uninterrupted supply of materials that meet Intarcia Quality Specifications● Assures that incoming materials used in GMP operations comply with Intarcia Quality Specifications● Assures that internal procedures for warehousing and distribution are compliant with FDA and EMA regulations● Assures that each lot of critical supplies is withheld from use until the lot has been sampled, tested, or examined consistent with CFR 21, Part 211 and EMA regulations● Assists the Executive Director of Regulatory Affairs and Quality Assurance and Executive Management of Intarcia in the development and maintenance of crisis management programs and product recalls● Maintains a state of GMP compliance and inspection readiness. Plans for, organizes, and assists the Executive Director of Regulatory Affairs and Quality Assurance during regulatory inspections to ensure successful outcome● Organizes and chairs a Material Review Committee ● Provides periodic updates to senior management

Quality Assurance oversight of manufacturing, testing, and lot disposition for clinical supplies. Owner and administrator of all quality systems such as deviation, change control, CAPA, complaints, material review board. Quality oversight of external CMO and partner sites.● Manage Global QA Operations including quality oversight of all CMC activities across both Janssen AI sites, several partner and contractor sites, and interaction with many J&J SMEs ensuring regulatory compliance in US, EU, and Canada● Oversee external manufacture of API, drug substance, drug product, and finished supplies at several global partner and contract manufacturing sites including batch documentation review and lot disposition for small volume injectables (adjuvants, vaccines, and monoclonal antibodies)● Created all GMP quality systems and lot release procedures after transition from Elan to Janssen AI● Manage stability coordination group including data trending and period of use assignment● Provide quality oversight of API manufacturing suite commissioning and decommissioning activities● Prepare for product commercialization including creation of all quality systems and lot release procedures for releasing commercial product● Participated in inspection readiness activities in preparation for PAI including internal audits of all GMP documentation and systems, creating systems for partner oversight during inspections and through commercialization, and participating in mock inspections●Provide all GMP related training to personnel including procedural training and GMP compliance training●Lead team for implementation of Trackwise system for deviation and change control management●Perform all activities related to previous position

Dublin 2, Ie

● Oversee technology transfer and external manufacture and testing of API, drug substance, drug product, and finished supplies at several global partner and contract manufacturing and testing sites including batch documentation review and lot disposition for small volume injectables and oral drugs (small molecules, peptides, vaccines, and monoclonal antibodies)● Responsible for compliance management and oversight of QA Systems including deviation, CAPA, change control, material review board, and complaint management systems and database management for all ensuring timely completion and remediation assessments● Lead Management Review Program and quality metrics● Hire staff and oversee training and orientation of new auditors●Serve as primary representative for company at contract manufacturing and testing sites ensuring compliance to regulations and leading remediation efforts when required● Prepare all manufacturing and lot release related documentation from external manufacturing sites and performs lot release●Manage all issues related to product release and testing internally and externally while coordinating activities and timelines across all functional groups and partner sites●Maintain strong knowledge of the monoclonal antibody and small molecule manufacturing processes ● Responsible for oversight of clinical labeling and packaging of all clinical products ● Prepare, review, and approve GMP related documents such as methods, specifications, protocols, reports, validations, SOPs, batch records, labels, and other manufacturing related documents● Perform GMP audits both internally and externally for contractors and partners● Participate in budgeting activities for QA department ● Review analytical data and data summaries for release, stability, and other study testing both in-house and from contractors assuring cGMP compliance prior to submission to a regulatory filing

Dublin, Ie

Quality Control for a commercial transdermal manufacturing facility. Tested and released raw materials, intermediates, and finished products. Supported environmental monitoring of facility.● Supervisor of finished product and intermediate testing group● Performed analyses of all commercial products and stability studies including raw materials, intermediates, and final products for transdermal drug delivery systems● Compiled and reviewed data for approval and efficient release to QA● Performed research on materials in relation to functionality of product and method development ● Interviewed, evaluated, and recommended candidates to support commercial requirements● Performed method validation and transfer for raw materials, intermediates, and finished products● Created and performed IQ, OQ, PQ Validation for instruments and equipment ● FDA escort and QC representative for PAI and GMP inspections● Assisted in development of yearly budget● Provided oversight for creation and control of QC documents such as methods, SOPs, and specifications● Coordinated with Regulatory Affairs, Product Development, Manufacturing, and Analytical R&D to evaluate data and troubleshoot problems● Responsible for tracking and reconciliation of DEA controlled substances● Reviewed and approved all artwork for printed packaging components for global markets● Responsible for training analysts in SOPs and methods● Trained to support QA with line audits, sampling, AQL evaluation, and batch record review● Performed vendor audits● Established labs for USP/EP water testing and printed packaging component testing for QC

Mba, Sustainability

Ba, Biochemistry