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I am a Quality & Compliance Leader with broad experience in pharmaceuticals, medical devices and biologics industries. Over the past 25 years, I have demonstrated competency in drug Quality Assurance and compliance, process development, global regulatory agency requirements, risk management, coaching, process optimization and inspection preparation and management.Skilled at providing strategic analysis and leadership in development and implementation of quality strategies to gain product approval and certification maintenance. Proven record of applying quality tools and methodology to enhance and create cost effective innovative solutions. Excellent interfacing, collaborative, and relationship building skills, able to lead, train, and implement successful projects.My career spans many different Quality roles, international experience and cross-functional relationships. Over the years, I have developed core strengths in:► Leadership: Led and facilitated cross-functional teams to develop and update Quality Standards supporting Corporate Policies to ensure compliance with regulatory expectations for current Good Manufacturing Practices.► Facilitation: Represented business partners to assure business needs were addressed in Corporate Policies and Standards leading to Operating Unit success.► Project Management: Manage execution of portfolio of 44 Change Control Process Improvement projects & 14 Operations projects. Collaborated with business to implement improvements in the organization using Lean methodology.I am happy to make new professional acquaintances. Reach out if you would like to learn more about my experience.
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Principal ConsultantStaniague, LlcUnited States
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Sr. Director, Head Of Quality AssuranceInvox Pharma Mar 2024 - PresentLondon, England, Gb -
Director, Gcp QualityInvox Pharma Jul 2023 - Mar 2024London, England, Gb
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Director, Gcp QualityF-Star Therapeutics, Inc. Jul 2022 - Jul 2023Cambridge, Cambridgeshire, Gb -
Assoc. Director, Gcp Quality Inspection ManagementRegeneron Apr 2019 - Jul 2022Tarrytown, New York, Us -
Process Innovation Project Leader (Secondment)Ortho Clinical Diagnostics Jun 2018 - Apr 2019Raritan, Nj, Us-Manage execution of portfolio of 44 Change Control Process Improvement projects, and 14 Operations projects.-Provide thought leadership and influence to drive key decisions and drive customer satisfaction/improvement.-Project management incorporating input across multiple functions and outside partners.-Build relationships and effectively communicates status and opportunities for improvement throughout the team and across multiple levels of the business.-Collaborate with business to implement improvements in the organization using Lean methodology. -
Manager, Global Quality Systems Change ManagementOrtho Clinical Diagnostics Oct 2015 - Jun 2018Raritan, Nj, Us-Collaborate with global function leaders to drive process efficiency relating to changes to product, process, and related documentation. -Lead team of subject matter experts responsible for developing change orders and change plans used to execute changes in the organization. -Apply strong emphasis on organizational change, process improvement and problem solving to drive efficiency, compliance, and reduction in cost of quality. -Build close engagement with Regulatory, Validation, Operations, Quality, Compliance, Sales and Marketing, and Regional functions to ensure the Change Management process delivers solutions that enable the business to achieve strategic goals compliantly. -Head of Change Review Board, and served as member of Phase Development System Process Steering Committee and Complaint Handling Counsel. -Manage global projects. -Responsible for hiring, developing, and managing talent globally.
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Senior Compliance AuditorBristol-Myers Squibb Jun 2015 - Oct 2015Lawrence Township, Nj, Us-Led clinical site audits for monoclonal antibody products (Opdivo & Yervoy) clinical trials, inspection readiness, and system audits of Pharmacovigilance and Epidemiology. -Applied audit principles, procedures, and methods to prioritize and focus on matters of significance.-Collected information through effective interviewing, listening, observing and reviewing documents, records and data.-Evaluated independently and critically the quality management system and operations, balancing weaknesses against requirements and expectations. -
Post-Market Surveillance Manager, Quality AssuranceGe Healthcare, Life Sciences Oct 2013 - Jun 2015Chicago, Us-Responsible for post market surveillance QMS, quality and compliance in global post-marketing activities (Medical Affairs, Pharmacovigilance, and Product Complaints).-Communicated recommendations and solutions across direct organization and with cross-functional partner organizations.-Involved in complex decision making sometimes with external parties.-Managed Global Complaint Handling Units with direct reports in US and Norway.-Planned and managed system audits for 114 Pharmacovigilance local safety units globally.-Performed Root Cause Analysis, Corrective and Preventive Action and inspection management (EMA, MHRA, FDA including BIMO) process. -
Qa Leader - R&D Medical Diagnostics (Quality Partner For Clinical Operations And Pharmacovigilance)Ge Healthcare, Life Sciences Apr 2011 - Oct 2013Chicago, Us-Responsible for International audits of Pharmacovigilance, GE Healthcare affiliates, clinical sites, and distributors. Quality partner to R&D/Clinical & Pharmacovigilance.-Interfaced directly with customers and internal groups to resolve customer complaint Investigations and drive robust root cause analysis.-Developed global risk management tool to direct audits of high-risk pharmacovigilance responsible entities.-Hosted corporate audits of Pharmacovigilance.-Assisted with health authority inspections of both Clinical and Pharmacovigilance.
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Sr Drug Safety Specialist, PharmacovigilanceGe Healthcare, Life Sciences Jun 2008 - Apr 2011Chicago, Us-Ensured timely notification of IND Safety Reports to FDA and clinical investigators and wrote summary safety information for IND Annual Reports.-Trained, directed, and provided guidance and assistance to two Drug Safety Associates on daily Pharmacovigilance activities (including MedDRA coding on cases, narrative writing, handling challenging adverse event calls, running queries in drug safety database, and answering questions on compliance and documentation).-Reviewed peer literature and assessed inclusion in NDA Annual reports to FDA for all products.
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Drug Safety Specialist PharmacovigilanceGe Healthcare, Life Sciences Mar 2007 - Jun 2008Chicago, Us
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Drug Safety Associate, PharmacovigilanceAmersham Health Mar 2002 - Mar 2007FDA Inspection support of PharmacovigilanceCase quality and compliance reviewerExpedited Reporting Compliance (KPI)Serious Adverse Events (SAE) processingNarrative WritingLabeling AssessmentExperience with MedDRA codingPeriodic Safety Update Reports (PSUR) writing and data analysisReviewed and prepared medical literature for inclusion in Annual Reports to FDA- Designed an Access database to assist associates track results (abstracts) of literature searches.Advanced user in ARISg (Global Adverse Reaction Information System)System validation and user testing (PQ, OQ)
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Medical Affairs AssociateAmersham Health Feb 2001 - Mar 2002Responsible for:-Processing adverse event, product complaint reports from customers and patients-Professional services for MD, PharmD, RN, and RTs on use of our products (technical information, indications, literature, and patient guides).
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Logistics AnalystAmersham Health Jan 1999 - Feb 2001Responsible for:Managing orders and supplies of nuclear medicine products (radioisotopes) to a network of hospitals, independent pharmacies, and Amersham Health Pharmacies.Production planning for Iodine I-123 capsules.
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Print Production SpecialistCorporate Express Inc Jan 1997 - Aug 1998Responsible for operating printing press producing high volume and/or high quality point-of-sale pressure sensitive labels.-Flexo & Letterpress 4 to 8 impression stations, 6 to 12" webs.-Water & solvent based inks, UV-cure inks
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Accounts Receivable SpecialistMoore Labels, Inc. Feb 1996 - Jan 1997
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Internship - Credit & Risk ManagementPainewebber Uk Holdings May 1995 - Sep 1995 -
Internship - Credit & Risk ManagementPainewebber Uk Holdings May 1994 - Sep 1994
Gerald Stanley Skills
Gerald Stanley Education Details
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University Of PhoenixBusiness/E-Business
Frequently Asked Questions about Gerald Stanley
What company does Gerald Stanley work for?
Gerald Stanley works for Staniague, Llc
What is Gerald Stanley's role at the current company?
Gerald Stanley's current role is Principal Consultant.
What is Gerald Stanley's email address?
Gerald Stanley's email address is ge****@****ail.com
What is Gerald Stanley's direct phone number?
Gerald Stanley's direct phone number is +131847*****
What schools did Gerald Stanley attend?
Gerald Stanley attended University Of Phoenix.
What are some of Gerald Stanley's interests?
Gerald Stanley has interest in Education, Health.
What skills is Gerald Stanley known for?
Gerald Stanley has skills like Fda, Pharmacovigilance, Pharmaceutical Industry, Gcp, Clinical Trials, Capa, Quality System, Clinical Research, Quality Auditing, Regulatory Affairs, Medical Devices, Quality Assurance.
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