Leo Posner Email and Phone Number
Leo Posner work email
- Valid
- Valid
- Valid
- Valid
- Valid
Leo Posner personal email
Leo Posner phone numbers
• Pharmaceutical experienced Ph.D. leader in QO and QA roles in Vaccine, Biopharmaceutical, Contract, Consumer and Medical Device companies. • Have demonstrated strengths in quality operations, supplier quality, laboratory management, analytical methods development, quality assurance, project management and regulatory compliance. • Extensive experience with regulatory inspections, internal and external audits and addressing agency observations. • Experienced in manufacturing operations,managing enterprise capital projects and departmental budgets.• Company award recognized leadership, teamwork and personnel development.Specialties: Extensive cGMP experience with pharmaceutical, consumer, vaccine, medical device and contract manufacturers. •Six Sigma APEX Green and Black Belt Certification•PMP and FPX Certification•Highly proficient in StatLia, MS Office applications, Documentum, Compliance Wire, SAP Quality Module, EtQ, Visio, TrackWise, SmartLAB•President and Board Member of Parenteral Drug Association (PDA), Delaware Valley Chapter, and American Association of Pharmaceutical Scientists
-
LinkedinAmbler, Pa, Us
-
Quality HeadThe Janssen Pharmaceutical Companies Of Johnson & Johnson Jul 2021 - PresentRaritan, New Jersey, UsLeading North American Stability and Laboratory operations for Janssen Pharmaceutical’s small molecule product platforms. The organization is responsible for development, clinical, tech transfers and stability testing for consumer and finished product dosage forms. -
Franchise Quality LeaderJohnson & Johnson Medical Devices Companies Jul 2019 - PresentNew Brunswick, New Jersey, UsLed the External Manufacturing Quality organizations for DePuy, Synthes and Ethicon Endo Surgery developing, implementing and executing strategic initiatives for Trauma, Joint Reconstruction, Spine, Mitek sports and Surgical Device product franchises. -
Na Director, Supplier Qa, Strategy & IntegrationDepuy Synthes Companies Of Johnson & Johnson Jan 2016 - Jul 2019Raynham, Ma, Us• Led the Regional Supplier Quality Assurance organization and provided supplier control processes across DePuy Synthes manufacturing sites. • Developed and implemented a worldwide risk management strategy to further improve the region's risk profile.• Responsible for identifying, mitigating and escalating quality and compliance risks within DePuy Synthes supply chain.• Developed and monitored quality systems to ensure each site met its objectives for supplier controls.• Ensured effective support for regulatory, internal audit and Notified Body inspection at the sites and strategic suppliers. -
Director, External Manufacturing QaJohnson & Johnson Jul 2013 - Jan 2016New Brunswick, Nj, Us• Platform leader for McNeil Consumer Healthcare’s external contract packaging organization. Ensuring all quality and compliance standards are adhered to across six external packaging sites.• Responsible for overall compliance of all McNeil products filled, packaged and trade customized to GMPs/GDPs and applicable regional regulations.• Ensure receipt of bulk product and final packaging in all configurations conforms to McNeil and external contract processes for distribution, product/process changes, in-line assessments and final product release.• Review and approve all packaging line trial protocols, packaging line validation reports and technical transfers related to manufacturing and packaging as well as the review and approval of all Quality Agreements related to each external manufacturer.• Lead enterprise due diligence assessments for existing contract manufacturers to identify and mitigate potential risks • Support McNeil’s quality system by reviewing and approving deviations, CAPAs, change control, notification and escalation to management, quality metrics and continued presence with each contract manufacturer. -
Site Quality LeaderJohnson & Johnson Nov 2010 - Jul 2013New Brunswick, Nj, Us• Directing all site regulatory and compliance activities including Quality Assurance, Product Release, Validation, Quality Control, Quality Systems, External Partner relationships, and Regulatory Compliance. • Responsible for the daily management of 8 direct reports, 115 indirect reports and overall operation of the site Quality Compliance business unit. • Chair the site Quality Council, Escalation to Management events and QSMR reporting to McNeil Quality Council. • Leading all site efforts related to the Consent Decree and execution of the Work Plan• Leading all site regulatory activities including managing inspections, observation responses, Inspection Readiness and Field Alert reporting. • Responsible for coordination of quality review and approval of site process change requests, consumer complaints and deviations. • Review and approve all level one site investigations and leading the site deviation reduction program. • Successfully managing a multi-million dollar operating budget.
-
Director, Regulatory ComplianceCharles River Laboratories Oct 2006 - Dec 2010Wilmington, Massachusetts, Us• Responsible for ensuring the clinical biopharmaceutical manufacturing site operates within strict regulatory compliance to both GMP and GLP environments. • Responsible for direct liaison between regulatory authorities for inspections, registrations and responses to regulatory and client events.• Directed all regulatory and compliance activities associated with Product Release, Site Validation, Quality Systems, Vendor/Supplier relationships, Deviation Management and Regulatory Affairs. • Represented all manufacturing sites as a member of the senior management team to develop quality strategies for three domestic and four international sites.• Responsible for the release or rejection of clinical and manufacturing batches for clinical Phase I and II studies.• Hosted multiple external audits and regulatory inspections (FDA, IMB, EMA, TGA and USDA) • Managed the site’s quality systems (deviations, change control, CAPA, Quality Agreements) -
Director, Quality ControlNeose Apr 2005 - Nov 2006Us• Managed all Quality Control activities for Analytical Operations (Biochemistry, Immunoassay, Virology, Microbiology and Analytical Development), Environmental Monitoring, Auditing and Stability. • Managed the tech transfer of analytical methods to multiple CROs. • Representative of the Product Specification and Stability Steering Committee.• Drafted the analytical and stability CMC sections for the firm’s IND filing.• Developed the stability program for the company’s APIs and protein therapeutic candidate.• Quality representative for regulatory and third party manufacturing corporate audits. -
ManagerMerck & Co 1995 - 2005Rahway, New Jersey, Us• Directed the professional development of salaried supervisors and analytical chemists.• Managed the laboratories daily operation averaging over 80,000 assays performed in a year.• Managed all financial aspects of a $3 MM budget.• Coordinated over fifteen analytical method transfers for vaccine and sterile pharmaceutical products. • Led three area heads in compiling analytical CMC filings for vaccine supplement. • Conducted the review and approval of all laboratory atypical assay investigations. • Lead and resolved multiple analytical issues. • Represented the laboratory organization in fourteen domestic and international regulatory inspections and eight PAIs.• Divisional QMS leader for laboratory related gaps.• Capital project leader for the construction of the Sterile Pharmaceutical Laboratory.• Project manager for the design and roll out of the Template Records Information Management system (TRIM Captura 4.3) within Laboratory Operations.
Leo Posner Skills
Leo Posner Education Details
-
Seton Hall UniversityOrganic Chemistry -
Fordham UniversityChemistry
Frequently Asked Questions about Leo Posner
What company does Leo Posner work for?
Leo Posner works for Linkedin
What is Leo Posner's role at the current company?
Leo Posner's current role is Quality Head at the Janssen Pharmaceutical Companies of Johnson & Johnson.
What is Leo Posner's email address?
Leo Posner's email address is lp****@****jnj.com
What is Leo Posner's direct phone number?
Leo Posner's direct phone number is +126757*****
What schools did Leo Posner attend?
Leo Posner attended Seton Hall University, Fordham University.
What skills is Leo Posner known for?
Leo Posner has skills like Microsoft Office, Visio, Gmp, Cgmp, Validation, Quality Assurance, Sap Qm, Contract Operations, Consumer Healthcare, Vaccines, Biosimilars, Cro.
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial