Graeme Lowe Email and Phone Number
Graeme Lowe's Location
Le Landeron, Neuchâtel, Switzerland, Switzerland
Graeme Lowe's Contact Details
Graeme Lowe work email
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Graeme Lowe personal email
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Graeme Lowe phone numbers
About Graeme Lowe
I am used to operating in a global role leading teams in multiple locations, this means that above all I value Diversity & Inclusion, in a global role where English is not always the first language it is so important to value your team, to listen & above all to trust them. I have experience in the Pharma/API, Sterile DP/DS & Car-T. I have continually looked for challenge and change, one of my main qualities is the ability to solve problems and make decisions and deliver change. In all the different roles below I have made it a priority to lead and develop my staff, maintain the highest Quality Standards, deliver excellent customer service and financial performance possible. I have extensive experience of Regulatory Audits and have been through numerous audits from FDA, MHRA, ANVISA, Swiss Medic and other countries.
Graeme Lowe's Current Company Details
Graeme Lowe Work Experience Details
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Executive Director External Manufacturing Quality PharmaBristol Myers Squibb Dec 2023 - PresentLawrence Township, Nj, Us
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Head Of Quality Internal Manufacturing PharmaBristol Myers Squibb Feb 2020 - Nov 2023Lawrence Township, Nj, Us
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Vice President Quality, Internal ManufacturingCelgene Aug 2019 - Feb 2020Summit, New Jersey, UsThe VP Quality Internal manufacturing is responsible for direction of the Quality Operations teams supporting manufacturing, Laboratory operations and releasing or certifying of all Celgene’s products produced in Celgene's Internal Manufacturing Network. This role provides leadership in an environment that promotes and maintains a team-based collaborative culture within the quality, manufacturing and laboratory operations involved in the manufacture of commercial products. This role is is a change agent for Quality. The function is responsible for establishing an effective Quality Control, Analytical Science & Technology, Quality Assurance department & Quality Systems to support manufacturing and packaging operations at site facilities in Boudry (CH), Couvet (CH), Phoenix (USA) & Zofingen (CH), In Addition oversees such activities at contractors employed to produce products. The function is responsible to evaluate GMP compliance capability at the site facilities and to make recommendations as required regarding any resources necessary to achieve compliance to current or emerging regulations. -
Executive Director, Head Of Internal Manufacturing Quality At CelgeneCelgene Dec 2018 - Feb 2020Summit, New Jersey, UsThe Global Head Small Molecule Quality Operations is responsible for direction of the Quality Operations teams supporting manufacturing, Laboratory operations and releasing or certifying of all Celgene’s products produced. This role is a leadership role that will provide an environment that promotes and maintains a team-based collaborative culture within the quality, manufacturing and laboratory operations involved in the manufacture of commercial products. This individual is a change agent for Quality.The function is responsible for establishing an effective Quality Control, Analytical Science & Technology, Quality Assurance department to support manufacturing and packaging operations at site facilities in Boudry, Couvet, Phoenix & Zofingen. The function is responsible to evaluate GMP compliance capability at the site facilities and to make recommendations as required regarding any resources necessary to achieve compliance to current or emerging regulations.
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Executive Director, Global Head Of Commercial Laboratory OperationsCelgene Oct 2017 - Nov 2018Summit, New Jersey, Us• Responsible for the Commercial Quality Control Laboratories (Inc. Microbiological labs) located at Boudry, Couvet and Phoenix and Summit (CAR-T)• Directs all operational aspects of the Laboratories in support of Stability, raw material, in-process, finished product, environmental monitoring and investigative related testing functions.• • Oversee complex investigations / quality testing issues/deviation in order to analyze and propose corrective actions to prevent re-occurrence and work with QA for product disposition.• Identify best practices both internally and external, through comprehensive bench marking, define the implementation strategies and roll out through network.• Work with Heads of Manufacturing to ensure full alignment of Commercial Product Testing schedules to comply with business needs.• Develop “best in class” compliant laboratory practices.
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Quality Director, FqmrShire Jun 2016 - Sep 2017Tokyo, Jp, Jp• Manage all aspects of the Quality Operations at the Neuchâtel facility, ensuring that quality systems and all quality related functions are in place and meet current Good Manufacturing Practices (cGMP), Shire and other regulatory quality standards and requirements.• Lead and manage a large Quality team of up to 150 colleagues.• Manage application of Shire strategic goals and develop Neuchâtel Strategic plan.• Vison and strategy, staffing, organization and development of personnel and organization• Achievement of defined goals and targets in order to drive the Neuchâtel plant to reach operational excellence.• Ensure safety, EHS, GMP rules are followed as well as related national and international rules within department.• Setup PMO´s and projects for team members to achieve daily operations goals as well as strategic quality goals.• Identify potential individuals and set appropriate development plans. Support the development and training of team members.• Report to VP Quality- Biologics on a routine basis the goals, the achievements, the gaps and the opportunities for improvement.• Implement and review of the effectiveness of quality systems.• Build-up and maintain good relationship with operations and other functions (e.g. R&D, RA, Marketing).• Manage inspections by third parties (e.g. inspections by notified bodies and by regulatory agencies) incl. internal assessments. • Regularly review quality and business activities during e.g. Quality Management Review, Business Review project review, CAPA Review and set corrective and preventive measures.• Member of the Core and Local Site Leadership Team.• Cooperation with other Shire facilities, especially process related facilities (TO, Lessines, Vienna, Singapore)• Lead the Continuous Improvement program for Quality, driving efficiency and NVA in the organisation. -
Senior Manager LaboratoriesBaxalta Mar 2015 - May 2016Illinois, Us• Leads the QC laboratory from a budget, Organizational, Lab Strategy and team development point of view• Develops 3 to 5-year strategy for the organization, develops operational budget and capital budget for quality control organization. Completes budget and adheres to budget/forecast. Continues to determine Value Improvement Projects (VIPs) to lower operational costs and improve lab efficiency• Interacts frequently with all levels of internal management as well as across functions and business units. • Directs organization of 4 to 5 direct reports (Managers) and approximately 100 indirect headcount. Manages overall coaching, training, development and succession plans for the team. • Actively participate in the Global lab Strategy• Develops and deploys the quality systems (e.g. laboratory investigations, out-of-specification investigations, LIMS, assay validation, management review, CAPA, and process control) that ensure products conform to defined requirements.• Understands and deploys processes to assure conformance to regulations. Actively leads or presents in regulatory inspections. • Manages interactions with customers and regulators concerning the quality of products, systems and processes. • Responsible for adherence to specifications and procedures that have been established to ensure product quality in area of responsibility. • Oversees the development and implementation of standards, methods, procedures and sampling for inspection testing and evaluating the precision, accuracy and reliability of the product. • Member of the facility Quality Leadership Team (QLT), delegates for the FQMR as required.• Out of specification or significant atypical trends should be investigated. Any confirmed out of specification result, or significant negative trend, affecting product batches released on the market should be reported and escalated accordingly. -
Director Of Development And Analytical Solutions (Das)Catalent Pharma Solutions Sep 2011 - Feb 2015Somerset, Nj, UsDirector and General Manager for the new DAS Laboratory based in Swindon. Responsible for Operations, Quality, Finance, PM & Contracts etc and Full P&L accountability. -
Quality Control ManagerCatalent Pharma Solutions Nov 2009 - Aug 2011Somerset, Nj, UsResponsible for two independant Laboratories, one supports the soft gel capsule business and one supports the Zydis facility.
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Quality Control ManagerPfizer Ltd Jan 1993 - Oct 2009New York, New York, UsThe main responsibilities are: -•Leading, coaching and developing the performance of the teams.•Managing the resources to ensure medium to long-term departmental objectives and time scales are achieved.•Planning and completing projects.•Ensuring continual compliance with FDA, MCA and GMP requirements.•Liasing with a cross section of Pfizer disciplines and external suppliers.•Ensuring the laboratories maintain a focus on customer service.•People management skills. •Driving RFT, Method one, Quick wins & Green Belt Initiative’s•A good understanding of Analytical Chemistry.•Batch release of Raw Materials, Intermediates, and API’s. •Implementation of the Raw Material Supplier Qualification Program.•Reorganising and reshaping the QO labs as required through the PNS transition.•Deputise for the Quality Director as and when required•Part of the Sandwich Site Extended Leadership Team
Graeme Lowe Skills
Fda
Analytical Chemistry
Gmp
Glp
Change Control
Validation
Technology Transfer
Capa
Gxp
V&v
Quality System
Lims
Regulatory Affairs
Computer System Validation
21 Cfr Part 11
Sop
Pharmaceutical Industry
Cleaning Validation
Contract Manufacturing
Hplc
Clinical Trials
Clinical Development
Pharmaceutics
Regulatory Submissions
Laboratory
Biotechnology
Aseptic Processing
Quality Control
Biopharmaceuticals
Chromatography
Vaccines
Drug Development
Formulation
Regulatory Requirements
Dissolution
Ind
Chemistry
R&d
Drug Discovery
Quality Assurance
Management
Life Sciences
Six Sigma
Medical Devices
Manufacturing
Graeme Lowe Education Details
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The University Of HuddersfieldBiochemistry & Biotechnology
Frequently Asked Questions about Graeme Lowe
What company does Graeme Lowe work for?
Graeme Lowe works for Bristol Myers Squibb
What is Graeme Lowe's role at the current company?
Graeme Lowe's current role is Executive Director External Manufacturing Quality Pharma.
What is Graeme Lowe's email address?
Graeme Lowe's email address is gr****@****rld.com
What is Graeme Lowe's direct phone number?
Graeme Lowe's direct phone number is +1 908-673*****
What schools did Graeme Lowe attend?
Graeme Lowe attended The University Of Huddersfield.
What skills is Graeme Lowe known for?
Graeme Lowe has skills like Fda, Analytical Chemistry, Gmp, Glp, Change Control, Validation, Technology Transfer, Capa, Gxp, V&v, Quality System, Lims.
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