Christopher Ames Email and Phone Number
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A dedicated pharmaceutical quality assurance leader with over 25 years of experience, I am passionate about ensuring the safety and efficacy of pharmaceutical products. I have a relentless commitment to quality, compliance, and team empowerment guiding quality programs for traditional pharmaceuticals and biologics, collaborating with manufacturing and regulatory colleagues, and enhancing quality systems. I have a proven track record of building and leading high-performing quality teams while fostering a culture of quality excellence. If you're seeking a quality leader with a track record of elevating quality standards, let's connect to explore how I can add value to your team.Highlights of Core Competencies:Ethical and Professional Conduct: Uphold the highest ethical standards in pharmaceutical quality assurance, ensuring data integrity and product safety, and promoting professional conduct among team members.Team Leadership: Proven ability to build, motivate, and lead cross-functional quality teams, fostering a culture of quality excellence, continuous improvement, and accountability.Communication and Stakeholder Engagement: Strong interpersonal and communication skills for collaborating with cross-functional teams, senior management, and regulatory agencies to convey quality-related information and resolve issues.Validation and Qualification: Experience in validation and qualification processes, including equipment, processes, and systems, to ensure consistency and reliability in pharmaceutical manufacturing.Supplier and Vendor Management: Proficient in managing and assessing third-party suppliers and contract manufacturers to ensure their compliance with quality and regulatory standards.Risk Management: Skilled in identifying, assessing, and determining the criticality and potential impact of quality-related issues within pharmaceutical operations in order to mitigate quality and compliance risks, enabling proactive measures to prevent issues and enhance product safety.Root Cause Analysis: Adept in identifying and addressing the root causes of quality and compliance issues to prevent their recurrence.Change Control and CAPA: Excel in managing change control procedures and corrective and preventive action processes to address and resolve non-conformances and quality issues effectively.Regulatory Compliance: Possess deep understanding of global regulatory requirements, including FDA, EMA, and other regional authorities, to ensure adherence to Good Manufacturing Practices (GMP).
Idrx
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Head Of QualityIdrx Sep 2024 - PresentLeading the Quality function at IDRx as we develop IDRX-42 for GIST and our quality systems
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Pharmaceutical Quality ConsultantAmes Gmp Quality Solutions Llc Jan 2024 - Present
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Senior Director Quality OperationsEqrx Aug 2021 - Nov 2023Responsible for the Quality Assurance oversight of GMP activities for EQRx. Also providing oversight to Quality Systems.
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Executive Director Quality Assurance / Quaity ControlAkorn, Inc Aug 2019 - Jul 2021Lake Forest, Il, UsSite Quality Head. Provided leadership to all Quality activities on site. Departments included chemistry lab, microbiology lab, validation, training, Quality Assurance, Quality Systems, and remediation team -
Senior Director Quality Assurance GmpAkebia Therapeutics May 2018 - Aug 2019Cambridge, Ma, UsProvided leadership for the quality assurance oversight of the drug substance and drug product manufacturing at contract manufacturers for clinical and commercial products. -
Experienced Pharmaceutical ProfessionalNew England Dec 2017 - May 2018Experienced Pharmaceutical Professional with a demonstrated history of working in the pharmaceutical and biotechnology industry for innovator, generic, and contract manufacturing companies. Held corporate and site management roles in validation and equipment qualification and site and department leadership roles in quality. Excellent oral and written communication, organizational, interpersonal, and collaborative skills. Experienced in most parenteral and solid drug product dosage forms and active pharmaceutical ingredients. Highly skilled in all aspects of validation: process, cleaning, sterilization, aseptic process, analytical method, and facility, equipment, and utility qualification.
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Quality DirectorEmergent Biosolutions Oct 2017 - Dec 2017Gaithersburg, Maryland, UsSite Sold by Sanofi Pasteur to Emergent Biosolutions.Site Quality Head. Provide strategic direction, guidance, and leadership to the Quality Organization at the Canton site ensuring the quality and compliance systems meet company policies and regulatory agency expectations. Accountable for the site quality department including the chemical and microbiological testing, compliance, documentation, batch record review and release, training, and stability of commercial products. Provided oversight of establishment and monitoring metrics, supplier quality program, validation, computer systems, and quality systems while fostering continuous improvement and inspection readiness. Provided review and approval of Standard Operating Procedures (SOPs), batch records, specifications, and change control documentation. Supervised staff of 4 direct reports and an extended team of 40, which includes regular feedback, performance appraisals, and career development. -
Director Site Quality OperationsSanofi Pasteur Mar 2016 - Oct 2017Paris, France, FrSite Quality Head. Provide strategic direction, guidance, and leadership to the Quality Organization at the Canton site ensuring the quality and compliance systems meet company policies and regulatory agency expectations. Accountable for the site quality department including the chemical and microbiological testing, compliance, documentation, batch record review and release, training, and stability of commercial products. Provided oversight of establishment and monitoring metrics, supplier quality program, validation, computer systems, and quality systems while fostering continuous improvement and inspection readiness. Provided review and approval of Standard Operating Procedures (SOPs), batch records, specifications, and change control documentation. Supervised staff of 4 direct reports and an extended team of 40, which includes regular feedback, performance appraisals, and career development. -
Director Commissioning And QualificationSanofi Pasteur Oct 2014 - Mar 2016Paris, France, FrProvided strategic direction, guidance, coaching, leadership and communication between sites in the harmonization and improvement of the commissioning and qualification practices at all six (6) US and European sites. Provided site support where needed. Led the internal global Validation Community of Practice for sharing best practices and review of global qualification and validation documents. Participated in the design review and establishment of qualification approaches for major capital projects.
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Director Quality Assurance ValidationSanofi Pasteur Sep 2011 - Oct 2014Paris, France, FrDeveloped and provided leadership, strategic direction, and resource scheduling to the quality assurance group who provided QA oversight to all aspects of validation including process, cleaning, sterilization, analytical method, computer system, and equipment commissioning and qualification (manufacturing and laboratory) in the Allston facility. Recruited and supervised staff of six (6) direct reports, which included regular feedback, performance evaluations, and career development and management of 4-15 contractors. Prioritize reviews to manage multiple projects. Managed and led the QA oversight and defense during the third-party review of Consent Decree Validation activities covering facility, equipment and utility qualifications following renovation of the QC laboratories, biologics purification facility, and development laboratories, validation of steam sterilization and cleaning, validation of revised methods, revalidation of the manufacturing process, and creation of procedures for validation (process, cleaning, sterilization), qualification, and test method validation. Reviewed and approved Standard Operating Procedures (SOPs), batch records, specifications, and change control documentation. Qualified trainer for site validation procedures.
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Director ValidationHospira Sep 2010 - Sep 2011Lake Forest, Il, UsResponsible for the Validation program within Hospira at the corporate level as well as the site level. Provided coaching, guidance and direction to the corporation for process, cleaning, and sterilization validation and equipment qualification. Acted as Subject Matter Expert for validation. Provided strategic direction, guidance, and leadership in the identification and implementation of best practices, harmonization and improvement of the validation programs at all the twelve (12) global sites in the US and Europe. Provided on-site support for validation efforts when required. Managed 12 site Validation Managers at global locations and an additional three (3) direct reports at the corporate level Subject Matter Experts. -
Director Global ValidationCatalent Pharma Solutions Jul 2007 - Sep 2010Somerset, Nj, UsLed the implementation of qualification and all validation aspects of the global quality system at all the Catalent global sites in the US, Europe, Australia, Asia, and South America. Provided oversight and functioned as a technical resource or Subject Matter Expert for validation. Authored and lead finalization of corporate policies and standards for process validation, cleaning validation, and facility, equipment, and utility qualification. Established metrics to measure right the first time, on-time projects, and deviations to monitor compliance, effectiveness, and efficiency of validation programs. Led the identification and implementation of best practices in validation. Provided on-site support, coaching, mentoring and guidance to the site validation organizations on process validation, packaging validation, cleaning validation, equipment qualification, process automation, sterilization validation, aseptic process simulations, and computer system validation programs. -
Director Of EngineeringRoche Pharmaceuticals May 2003 - Jul 2007Switzerland 🇨🇭 , ChDirect the validation program at the Roche sites in Nutley and Totowa, NJ. Responsibilities included:• Process validation, packaging validation, cleaning validation, equipment qualification including process automation, and computer system validation programs for the on-going manufacturing of solids, liquids and sterile antibiotics. • Authored the site Validation Master Plan and provided oversight or approval of the Sub Plans. • Implemented a stream lined approach to equipment qualification and process validation. • Provided support for process and product investigations. An integral management team member of the site implementation of a lean six sigma program and have received basic Six Sigma training and Project Champion’s training. • Primary contact for Validation issues during regulatory authority (e.g. FDA, EMEA) audits. • Provided input and review of the Roche global validation guidances. -
Director Validation SupportSchering Plough Feb 1991 - May 2003Rahway, New Jersey, UsCareer at Schering began as a validation engineer and rose through various positions of increasing responsibility in quality and validation to Site, Quality Head, Director of Validation and Director of Validation Support. In the last role, I supported the validation efforts at three sites under the Schering Consent Decree.
Christopher Ames Skills
Christopher Ames Education Details
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University Of ConnecticutChemical Engineering
Frequently Asked Questions about Christopher Ames
What company does Christopher Ames work for?
Christopher Ames works for Idrx
What is Christopher Ames's role at the current company?
Christopher Ames's current role is Experienced Pharmaceutical Quality Assurance Leader | Excel in Driving GMP Quality Optimization and Compliance, Regulatory Excellence, and Cross-functional Team Success.
What is Christopher Ames's email address?
Christopher Ames's email address is ch****@****orn.com
What schools did Christopher Ames attend?
Christopher Ames attended University Of Connecticut.
What skills is Christopher Ames known for?
Christopher Ames has skills like Process Validation, Biotechnology, Pharmaceutical Industry, Change Control, Aseptic Processing, Validation, Quality Assurance, Fda, 21 Cfr Part 11, Gmp.
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