Brandon Foose Email & Phone Number

Remote

- Accountable for the Quality management of external suppliers' products, processes and related documents ~ Assure that the products supplied to patients are manufactured, tested in accordance with cGMPs, the registration file and any additional country specific requirements ~ Determine if product requirements (Quality Agreement, regulatory, or otherwise) are met and ensure that a quality systems are maintained ~ Monitor quality activities and systems at supplier and subcontractor facilities ~ Generate Quality risk and performance dashboards where contextual KPIs inform business partners on progress and overall health of contractor performance- Set objectives for projects and manage multiple projects within the division to drive quality excellence- Ensure all site Quality and Regulatory Systems and operations remain in full compliance with Regulatory filings and submissions- Work closely with the Business Excellence and Operations and Audit Resource to operationalize the responsibilities related to relationship management and oversight of vendors- Establish and provide the Quality and Compliance (QC) team with Quality Assurance Compliance guidance and decisions- Perform deviation investigations into quality issues including Root Cause Analysis, CAPA, and CAPA Effectiveness- Approve investigations and Change Control activities to ensure compliance with configuration management policies- Oversee and manage, prepare and deliver site Good Manufacturing Practices (also cGMP) training on Quality Systems- Support audits and inspections- Lead virtually based cross functional teams- Strong negotiation skills and is diplomatic in communication with internal and external customers

King Of Prussia, Pa

· Build partnerships within and outside of compliance to define, implement and advance strategic initiatives that improve business unit core value drivers· Lead Third Party Oversight program liaising with Business Owners, Technical Subject Matter Experts, Procurement, Quality Assurance, and Third Parties (CMOs, CROs, Academic)~ Ensure deliverables met and data/documentation meets expectations~ Developed/maintain dashboard and visualizations tools to increase visibility for Leadership Team· Drive impactful business results utilizing compliance metrics · Develop strategies and transfer knowledge to business partners for execution of tactical work plans· Coordinate Market Specific Requests for strategic (high priority) global regulatory filings, serving as single point of contact between scientific lines and regulatory leads· Assist in achieving objectives, regularly participating in Product Quality review and translate compliance strategic programs into business results

Collegeville, Pennsylvania

· Lead and assist in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues internally and externally - Assessments of External Service Providers (national and foreign based) that are engaged in GLP work, supply of materials for GLP work and the analysis of clinical samples - Internal assessments of GLP and clinical laboratories functions - Inspections of procedures and reports for GLP studies· Primary business contact for specific business areas (GMP, WREF [facilities], and Records Management)· Training coordinator for US Lab QA and GLP related training - Lead/contribute to the training, education, guidance and influencing of customers/business areas on quality and compliance policy and practices· Proactively identify, communicate and monitor business changes that could impact on quality or compliance within the department and across departments· Identify and mitigate compliance risks through effective assessments and/or via providing advice and consultancy to GQA and business units regionally and globally· Provide advice and consultancy to project teams and external partners to reduce regulatory risk· Identify business or reputational risks and suggest risk management solutions· Assure products meet regulatory requirements and that they conform to regulatory submissions· Establish improvement processes and set specific measurable targets and goals linked to GQA and business needs· Build and maintain effective internal business relationships within GQA and business units

Conshohocken, Pa

· Champion Biopharm Product Development & Supply (BPDS) implementation of Internal Control Framework and Risk Management· Drive compliance and continuous improvement activities through evaluation of metrics, KPIs, and emerging trends at various levels (local business unit, department, etc.)· Coordinate department-wide Management Monitoring Program, coordinate higher level internal Audit preparedness· Oversee quality metrics and dissemination for monthly, quarterly, and annual reporting to various groups of stakeholders· Lead R&D-wide project risk alignment and trending initiative· Coordinate and maintain of the compliance risk register; coordinating assessment of BPDS compliance risks and action plans· Involved in extensive matrix working both internal and external - Leading deviation investigations, Root Cause Analysis, continual improvement, data integrity, and 3rd party oversight· Responsible as an SME during external regulatory inspections and internal reviews and audits· Represent QRMC to internal parties and forums (Risk Management, Quality Council, Change Management, project teams) and external entities (Due Diligence for suppliers, Management Monitoring) · Coordinate regulatory submission review process for BPDS and support review and approval of submission content· Support asset filings and regulatory strategies and address key risk elements for ways-of-working (e.g. data integrity)· Engage Quality Assurance for ensuring cGMP compliance and maintenance of system infrastructure· Own and support cGMP systems (new and future) for effective management and visibility (trending and metrics) of performance· Liaison between QRMC and BPDS departments for development, understanding and implementation of quality systems and processes aligned with QMS and GSK Policy· Remain informed of current QMS, FDA, EU, PMDA, MHRA and other relevant industry standards and ensure their assessment of BPDS compliance risks and action plans

Conshohocken, Pa

· Utilize strategic leadership and vision to maintain cGMP · Provide compliance oversight within Biopharm Product Development & Supply· Involved in extensive matrix working both internal and external ~ Working on deviation investigations, Root Cause Analysis, continuous improvements, data integrity, and 3rd party oversight· Ensure alignment of biopharmaceutical compliance systems with established R&D and external regulatory policies· Engage appropriate Quality organizations and IT organizations to ensure cGMP compliance and maintenance of system infrastructure· Assist with Regulatory Submission review process for QC, provide commentary for regulatory submission and provide review and endorsement on new submissions· Compile monthly reports highlighting progress against Key Performance Indicators and other quality metrics· Work with Biopharm Regulatory Affairs and represent QC/GSK in consultation meetings with external agencies · Act as a Subject Matter Expert (SME) for QC processes during external regulatory inspections· Establish new business processes and maintenance of current work processes required to support the cGMP clinical manufacturing· Perform Compliance reviews for Certificates and Records of Analysis (CoA and RoA)· Uphold knowledge of current FDA, EU, QMS, and industry standards and ensure their assessment of GMP· Support cGMP systems including Change Control, CoA generation, record management, good documentation practices, Risk Management, SOPs, process improvement, regulatory submission process improvement, and data review· Evaluate compliance risks and action plans – make recommendations for implementation· White (Yellow) Belt lean sigma certified through GSK – Also a White Belt mentor

Conshohocken, Pa

• Responsible for running cGMP samples on biochemical assays such as various ELISAs, qPCR, HPLC, SDS-Page, Caliper, and Total Protein Assays for release and in-process testing • Provide bioanalytical support for biopharmaceutical products produced within Biopharm R&D • Responsible for participating in assay qualification and tech transfer • Adherence to standard operating procedures to maintain cGMP compliance Real time documentation in Electronic Notebook and LabWare/LIMS, maintain Critical Reagent Inventory • Participate in the investigating of OOS and atypical results obtained during cGMP analytical testing • Draft or revise analytical methods or SOPs in a cGMP documentation system • Preparation for internal and quality group audits• Establish and maintain critical reagent inventory tracking, Reference Standard ordering and tracking in COMET• Consolidate concentration data for drug substance processing steps from manufacturing batch records and track completion of testing records according to sample summary tables • Attend project Analytical Sub-Team and BioPPD meetings to gain exposure to project related activities and project team interactions• Attend Weekly Quality Forum sponsored by Quality Assurance to discuss deviations and CAPAs • White Belt lean sigma certified through GSK

Collegeville, Pa

• Lead and support timely and comprehensive investigations of Deviations and Customer Complaints - Lean Sigma White Belt (GSK Yellow Belt equivalent) and Business Lead Investigator trained for Deviation and CAPA ownership/authorship/leadership • Identify most probable root cause – lead RCA meetings, populate TrackWise, and coordinate closure with Pre-Clinical QA • Develop and support implementation of Corrective and Preventative Actions (CAPAs) to resolve gaps determined from quality investigations• Compile metrics pertaining to quality issues/trends site wide and globally to identify and address gaps• Own local Risk Register/Concerns Log and coordinate global meetings • Represent Packaging Operations at site Tier 1 Quality council and across various other matrix team settings• Oversee, develop, improve and carry out the Level 1 audit program and ensure its effectiveness• Key business contact for management during and following external regulatory audits and internal MIA and Level 2 audits• Provide input to the design and continuous improvement of GDS Operations processes including SOPs and Training• Coordinate training activities to ensure records are managed and readily accessible for scheduling and auditing purposes • Lead and participate in Communities of Practice (Quality Leads, Training, and Level 1 Audit) and Quality Forums• Point of contact for Quality Alerts and coordinate global and site specific responses• Coordinate and guide project work for Co-Op students hired to support specific initiatives• Maintain and evolve knowledge of cGMPs and regulatory requirements, experience in packaging/labeling of pharmaceutical products, equipment packaging, and labeling operations to support clinical trials/supplies and investigational materials

Royersford, Pa

• Collaborate with Biological Reagents and Assay Development group in the design and implementation of biochemical and cellular assays for large (HTS), small (focus screens), and continuous (compound profiling) screens as support for designated research sectors or across sectors when applicable (kinases, methyl transferases, etc.) Includes publication of protocols and maintaining current laboratory notebooksResearch sectors include, but not limited to: epigenetic, cancer metabolism, heart failure, etc. • Present and report published data to program teams and engage in dialogue regarding lead optimization, MOA, Structure-Activity-Relationship, and in vivo and in vitro progress • Develop and carry out assays for a novel approach to HTS, Encoded Library Technology DNA-tagged compound libraries are screened against protein targets and DNA is subsequently quantified through qPCR, amplified through emulsion-PCR or cluster generation, and sequenced on Roche 454 and/or Illumina • Techniques applied: qPCR, PCR, DNA sequencing, IC50, EC50, FLINT, FRET, IMAP, Fluorescent Polarization, absorbance, Scintillation Proximity assays, SDS Page protein gels, protein binding and affinity assays, enzymology(titrations, time courses, determining kM, etc.), and other common techniques • Platforms competent in:Roche 454, Illumina, LightCycler 480, Fluorescence Plate Readers and Imagers (Envision, Viewlux, SpectraMax, Acquest, Analyst, etc.) SpotFire, thermo cyclers, liquid handling devices (Matrix, Thermo Combi, Multidrop, Hummingbird, etc.) other basic laboratory apparatuses, Lotus Notes, Microsoft Excel, GraFit, compound routing and ordering

• Performed stability and release assays for PCR diagnostic products (HBV, HIV, HPV, etc.) • Conducted automated and manual PCR amplification and detectionManual – thermo cyclers (TC 9600 and 9700), Microwell plates, plate readers (light absorbency), etc. Automated - COBAS systems, ABI. Prism 7700 (real-time PCR), etc. • Executed automated and manual RNA and DNA extraction techniques Manual – centrifuges, ultracentrifuges, heat blocks Automated – AmpliNAT MPX, GT-12, etc. • Completion of batch sheets and entry into LIMs for validation; Adherence to GMPs, SOPs