Cambridge Isotope Laboratories, Inc. (CIL) is searching for a North America ISO Quality Manager based onsite in our Tewksbury, MA facility. CIL is the global leading company in a highly technical, extremely fast-growing industry and is a critical supplier to several scientific and high technology markets. CIL's growing customer base spans academia, pharmaceutical, medical diagnostic and semiconductor industries enabling collaborations with Nobel laureates, industry-leading scientists, and chemists. CIL partners with leading instrument manufacturers as well pioneering research groups that have expertise in product development and drive market growth. CIL is a subsidiary of the Otsuka Pharmaceutical Group and has had consistent growth for over 40 years.The North America ISO Quality Manager will be responsible for the maintenance and continual improvement of the organization’s Quality Management System for non-GMP products at all facilities in North America. This individual will be hands on, working with multiple sites and with multiple departments, to ensure that all non-GMP processes continue to conform to ISO 9001 standards. Required competencies include customer focus, chemical process manufacturing, working with cross-functional teams and leading change throughout the facility.Responsibilities
Work with site leadership to maintain and continuously improve an ISO 9001: Current version system / program for all non-GMP products that conforms to customer, internal, ISO 9001 and regulatory/legal requirements
Align programs between sites where possible to provide one quality vision
Implement other ISO standards as required by business needs
Responsible for supplier management program to ensure evaluation of, and reporting on, vendor quality systems
Coordinate and/or perform internal audits
Develop short-term and long-term plans and programs, together with supporting budget requests and financial estimates and monitor expenditure to achieve ISO certification and maintenance going forward
Lead periodic management review meetings for non-GMP products
Manage the Corrective Action and Preventive Action (CAPA) Review Board, internal and external audits, management review, and training programs
Monitor production process/procedures for continuous improvement
Define, develop and recommend corporate objectives and policies; Leverage industry practices and apply to internal systems and processes
Make recommendations for corrective action necessary to ensure conformity with quality specifications
Investigate (and correct) customer issues and complaints relating to quality and manufacturing operations
Design, develop and implement training programs
Coordinate and implement Lean, Kaizen and/or 5S activities with each functional work cell
Oversee Quality and Manufacturing Operations team to meet corporate KPI
Any projects/tasks assigned by the company
Requirements
Bachelor's degree required
10+ years of experience in an ISO chemical manufacturing environment
Experience handling the successful implementation of an ISO 9001:2015 program. Experience with ISO 14001 preferred
Strong knowledge of ISO elements
Proven track record of driving continuous quality improvement in a manufacturing environment
Certification such as a Lead Auditor or ASQ strongly preferred
Working experience with CAPAs and internal audit systems
Superior leadership, facilitation, and communication skills
Experience in electro-mechanical equipment or reagents is a plus but not required
Experience working in regulated environment is a must
Experience in auditing, interpreting, and applying regulations and compliance concepts is a plus
Detail oriented
Excellent communication and interpersonal skills and ability to work independently and with cross-functional teams
Travel to various North American facilities is required, twice quarterly
BenefitsCIL and CIS offer a competitive salary and comprehensive benefits including generous paid time off, Long Term Incentives, 6% matching 401K plan and health insurance with no in-network deductible.CIL is an EEO/Affirmative Action employer.Learn more about us on our website: www.isotope.comAbout Us:Cambridge Isotope Laboratories, Inc. (CIL) is the world’s leading producer of stable isotopes (http://www.isotope.com/userfiles/files/assetLibrary/METMATTHEWS.pdf) and stable isotope-labeled compounds. With approximately 750 employees and laboratories in four countries, CIL specializes in the process of labeling biochemical and organic compounds with highly enriched, stable (nonradioactive) isotopes of carbon, hydrogen, nitrogen and oxygen. Our chemists substitute common atoms (e.g., 1H, 12C, 14N, 16O) with rare, highly valued isotopes (e.g., 2H or D, 13C, 15N, 18O) so that the final product can be readily measured or traced using mass spectrometry (MS) or nuclear magnetic resonance (NMR). CIL’s products are utilized in laboratories, medical, government and academic research centers and health care facilities worldwide.We are proud that CIL products have contributed to medical advancements in cancer research, new-drug development, environmental analysis, and medical diagnostic research. In the past decade, as the fields of proteomics and metabolomics have developed as leading techniques for determining biomarkers for disease presence, progression and the monitoring of therapeutic response, CIL has worked closely with industry leaders and researchers to provide the stable isotope-labeled tools needed for improved quantitation and qualification of complex biological systems.After decades of research, stable isotopes have found their place in an ever expanding commercial scale applications in pharmaceuticals, semiconductors, flat panel displays as well as other high technology fields specifically with deuterium oxide (D2O) and deuterium gases. Pharmaceutical companies have begun to investigate deuteration of molecules that may provide advantages over their existing nondeuterated counterparts. In addition, increasing research into the potential medical advantages of new deuterated drugs is also occurring. In high technology, deuterated organic molecules and deuterium gas are commonly used in the manufacturing of microelectronics and OLEDs, which contribute to the increased lifetime of the devices.Learn more about us on our website: www.isotope.com