Mark Balboni Email and Phone Number
Principal & General Manager | GMP Compliance, Data Integrity and Quality Systems at
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Balboni Consulting Group LLC
Mark Balboni's Location
Beaverton, Oregon, United States, United States
Mark Balboni's Contact Details
Mark Balboni work email
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Mark Balboni phone numbers
About Mark Balboni
I am an experienced Quality Assurance and Good Manufacturing Practice generalist with a breadth of skills and adaptability, who is also a problem solver and data analyzer. I also enjoy being a mentor and a coach, which is especially rewarding as you witness the learning and growth over time.KEY SKILLS• Extensive knowledge concerning the cGMP regulations and compliance requirements,especially the applicability in an R&D environment, as well with novel technologiessuch as cell & gene therapy and complex issues like data integrity matters.• School-trained in quality assurance principles, statical process control, inspectiontechniques, conducting interviews• Highly skilled in problem detection and identification, developing solutions in short andlong-term corrective actions; as well as elimination of unnecessary work and seekingefficiencies in processes.• Quite comfortable working in a variety of settings, including startups and R&D-orient-ed ventures, medium-sized firms on up to multinational pharmaceutical and biotech-nology companies• Knowing what good looks like and what it takes to be best-in-class
Mark Balboni's Current Company Details
Balboni Consulting Group Llc
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Principal & General Manager | GMP Compliance, Data Integrity and Quality Systems
Mark Balboni Work Experience Details
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Principal & General ManagerBalboni Consulting Group Llc Apr 2019 - PresentUsOwner and Founder of a GMP and Quality Systems consulting firm, providing timely services to clients in the pharmaceutical, biotechnology, and medical device industries, both in the US and internationally.Portfolio of GMP Consulting Services:• GMP AUDITING: Sterile and non-sterile finished products/devices, suppliers of APIs and raw materi-als, testing labs, warehouses (GDP). This includes large and small molecule products as well as celland gene therapy treatments.• STRATEGIC ADVISEMENT: Healthcare authority communications/meetings, remediation and verifica-tion• INSPECTION SUPPORT: Hosting, front/back room support, mock interviews, etiquette training, readi-ness assessments, application conformance reviews• DATA INTEGRITY: Training, procedure development, auditing, staff interviews, internal investigations,coordination with legal counsel• DEVIATION INVESTIGATIONS & CAPA: Problem identification and resolution, report writing• TRAINING: General GMP topics, FDA interaction and preparation for FDA inspections, 1:1 mock in-terviews, auditing techniques• TECHNICAL WRITING: Validation protocols and reports, SOPs, annual product reviews, FDA corre-spondence, audit responses, strategic plans, trend analysis reports, and other technical reports• DATA / TREND ANALYSIS: Collection, review, analysis, and summary reporting for deviations, OOS,change controls, CAPA, complaints, product returns• PROJECT MANAGEMENT: Compliance remediation efforts, organizational/systems redesigns
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Vice President - TechnicalParexel May 2018 - Apr 2019Durham, North Carolina, UsProvided timely, cost-effective, and value-added solutions for clients facing serious regulatory issues, including 483s, Warning Letters, and Consent Decrees. Collaborated frequently with site executive leadership, FDA third-party law firms, and in-house counsel. Served as both a technical expert and mentor. Developed and assisted with the implementation of an entire data integrity program, including creation of multiple new procedures and rewrite of others. -
Principal & General ManagerBalboni Consulting Group Llc Apr 2017 - May 2018UsOwner and founder of a GMP and Quality Systems consulting firm who provides timely services to clients in the pharmaceutical, biotechnology and medical device industries in both the US and internationally.
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Senior Director Gmp ComplianceBiomarin Pharmaceutical Inc. Aug 2015 - Apr 2017San Rafael, Ca, Us-Lead an internal/external GMP and Computer Validation/Data Integrity audit function of 9 staff.-Successfully managed a department budget of $3M-Provide strategic advisement to executive staff on GMP compliance matters and acted as an internal SME-Designed/redesign and built key systems to support the audit functions in a growing company.-Ensured a high state of readiness for healthcare authority inspections and partner audits -
PresidentMark Balboni Llc Jan 2014 - Jul 2015Owner and founder of a successful GMP and Quality Systems consulting firm who provided timely services to clients in the pharmaceutical, biotechnology and medical device industries in both the US and internationally.
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Director, Strategic Compliance Services, Parexel ConsultingParexel May 2012 - Dec 2013Durham, North Carolina, UsLeadership and Management:• Served as a member of the consulting practice leadership team and managed a staff of 6 consul-tants.Project Management:• Led 20+ client assignments, managing teams of 4-12 consultants. Projects ranged from 3 weeks to8 months in duration.Client Business Development:• Successfully negotiated new client business with total sales in the tens of millions of dollars. Re-sponsibilities included preparing scopes of work, price estimates, and defending bids.Specialized Roles:• Acted as a loan executive for a client at a large chemical manufacturing site, supporting the site’sQuality Assurance Department for 3 months.• Worked full-time for 8 months at a sterile biologics manufacturer, focusing on media fill protocols,SOP reviews, facility evaluations, and validation studies for various processes.Regulatory and Quality Systems Experience:• Prepared Annual Product Reviews for 6 months at a client site specializing in transdermal systems.• Extensive experience preparing companies for FDA Pre-Approval inspections.• Hands-on experience designing and building Quality Systems.
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Principal Consultant, Parexel ConsultingParexel Mar 2005 - Apr 2012Durham, North Carolina, Us
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Associate Director Regulatory ComplianceBiogen Jun 2004 - Mar 2005Cambridge, Ma, Us• Strategic and Operational Direction: Directed strategic, tactical, and operational processes en-suring adherence to regulatory licenses, CMC commitments, and internal procedures.• Risk Assessment and Regulatory Expertise: Led the site risk assessment team and served as acompliance expert on GMP compliance matters.• Audit Management: Directed and participated in critical contract and vendor audits, as well as in-ternal audits of a sterile biologics manufacturing facility.• Team Supervision: Supervised the West Coast Drug Compliance Team, providing managementoversight and fostering professional development. -
Senior Consultant, Kmi/ParexelParexel May 1999 - Jun 2004Durham, North Carolina, UsAudit Experience:◦ Conducted GMP/FDA pre-approval (Mock PAI) and GMP/QSR audits for pharmaceuticaland medical device companies.◦ Performed comprehensive audits covering quality systems, including operational and riskassessments related to equipment qualification and process validation activities.• Reporting and Advisory:◦ Wrote and presented reports providing strategic assessments and problem resolutions.◦ Advised management on GMP compliance matters, including strategies for corrective andpreventive actions (short-term and long-term).◦ Conducted eviews under attorney-client privilege, providing compliance advice and as-sistance in FDA communications to mitigate legal risks.• Project Management:◦ Managed multiple medium to large GMP compliance projects, involving 10-12 consultantsand spanning up to 3 weeks in duration.• Compliance and Validation Expertise:◦ Performed extensive reviews and evaluations of equipment and utility system qualifications,process validation efforts, and validation master plans.◦ Specialized in assessing various sterilization approaches, including moist heat, filtration,ethylene oxide, and gamma irradiation.◦ Completed numerous audits and remediation activities for clients manufacturing drugs,medical devices, and biologics.• Documentation and Standards:◦ Prepared GMP improvement plans, compliance standards, and audit checklists, includingthose for Pre-Approval Inspections, Active Pharmaceutical Ingredients, HVAC qualification,and corporate/site stability programs.◦ Reviewed and prepared responses to FDA 483 and Warning Letters, aseptic media fill pro-tocols, and 21 CFR Part 11 risk assessments.• Industry Engagement:◦ Delivered presentations on various GMP-related topics at industry events.
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Gmp Manager Research ComplianceAllergan Mar 1996 - May 1999Dublin, Coolock, IeGMP Compliance and Auditing:◦ Directed GMP compliance and managed both internal and external audits for all R&D areasinvolved in drug and device development, focusing primarily on ophthalmic drug products,intra-ocular lenses, and lens care solutions. Audits included: site clinical supply aseptic fillmanufacturing operations, R&D and QC labs that developed specifications, tested raw ma-terials, completed release testing, and monitored product stability.◦ Supervised and trained two GMP auditors.◦ Reviewed CMC and Stability sections of NDAs and performed audits on data intended forFDA submission.◦ Conducted reviews of utility system qualifications for two newly constructed manufacturingfacilities (sterile clinical supply pilot plant and commercial biological production site).Software Auditing:◦ Audited software developers for document management systems, laboratory informationmanagement systems, and analytical instrument-driven software.◦ Reviewed and/or approved in-house computer hardware and software IQ/OQ/PQ docu-mentation (requirements specifications, test plans/protocols, final reports, test scripts, andraw data) for clinical patient databases and environmental monitoring/control systems.Inspection Readiness:◦ Assisted in the preparing for two separate New Drug Application pre-approval inspectionsby FDA at the Corporate HQ R&D operations, which were successful◦ Assisted in preparing the BOTOX sterile bulk manufacturing facility for its successful Cali-fornia state licensing inspection.◦ Collaboration with Pharmaceutical Sciences on audit approaches, document and datatechnical reviews, coaching, logistics and administration -
InvestigatorFda May 1990 - Mar 1996Silver Spring, Md, UsAs a member of the District Drug Team and the Pacific Region NDA/ANDA Pre-Approval Inspection Cadre, I performed drug GMP and pre-approval inspections. My inspections covered a range of dosage forms and facilities, including:• Finished Drug Product Manufacturing Operations: Inspected various dosage forms such as ster-ile solutions (both aseptically processed ophthalmics and terminally sterilized large volume par-enterals), semi-solids, solid oral dosage forms (tablets, hard and soft gelatin capsules), and positronemission tomography (PET) drug products.• Medical Device Manufacturers: Attended FDA’s resident Medical Device School and performedinspections of medical device manufacturers.• Active Pharmaceutical Ingredient (API) Manufacturers: Conducted inspections of API manufac-turers and contract test labs that performed chemical and microbiological analyses.• Training and Collaboration: Completed two lengthy LVP training inspections with an FDA NationalDrug Expert.• Law Enforcement Collaboration: Worked with state and federal law enforcement officers on nu-merous criminal investigations involving anabolic steroids, illegal importation of Chinese patentmedicines, Prescription Drug Marketing Act violations, and health fraud.AWARDS: Received three awards from the FDA Commissioner’s office related to: NDA/ANDA Drug Pre-Approval Inspections, team inspection of a large silicone breast implant manufacturer, and for multiple investigations related to the trafficking and distribution of anabolic steroids. -
Captain, Medical Service CorpsArmy National Guard Jan 1982 - Apr 1994Arlington, Virginia, UsServed in leadership and staff positions as a commissioned officer, including com-pany commander of a 240-person hospital unit. Was also prior service as an enlisted member of the U.S. Army Reserve, serving as a cannon fire direction specialist in a field artillery unit. Honorably Discharged in 1996. -
Quality Assurance EngineerAmerican Racing Equipment, Inc. Feb 1990 - May 1990Rancho Dominguez, Ca, UsConducted deviation investigations. Calculated scrap rates and performed supplieraudits. -
Quality Assurance Specialist (Ammunition Surveillance)United States Department Of The Army Apr 1989 - Dec 1989Arlington County, Va, UsAttended an intensive resident course in rural Illinois for 8 months covering basicquality assurance principles, fundamentals of statistical process control (SPC), in-spection and testing of ammunition, explosives and guided missiles.
Mark Balboni Skills
Fda
Gmp
Pharmaceutical Industry
Capa
Regulatory Affairs
Validation
Sop
Biotechnology
Quality System
21 Cfr Part 11
Change Control
U.s. Food And Drug Administration
Quality Assurance
Gxp
V&v
Data Integrity
Training
Auditing
Strategic Advisement
Technical Writing
Data Trend Analysis
Regulatory Inspection Support
Regulatory Requirements
Mark Balboni Education Details
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Weber State UniversityChemistry
Frequently Asked Questions about Mark Balboni
What company does Mark Balboni work for?
Mark Balboni works for Balboni Consulting Group Llc
What is Mark Balboni's role at the current company?
Mark Balboni's current role is Principal & General Manager | GMP Compliance, Data Integrity and Quality Systems.
What is Mark Balboni's email address?
Mark Balboni's email address is ba****@****xel.com
What is Mark Balboni's direct phone number?
Mark Balboni's direct phone number is +1 415 506*****
What schools did Mark Balboni attend?
Mark Balboni attended Weber State University.
What are some of Mark Balboni's interests?
Mark Balboni has interest in Education.
What skills is Mark Balboni known for?
Mark Balboni has skills like Fda, Gmp, Pharmaceutical Industry, Capa, Regulatory Affairs, Validation, Sop, Biotechnology, Quality System, 21 Cfr Part 11, Change Control, U.s. Food And Drug Administration.
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