Job description
Overview:
The successful candidate will have a sound working knowledge of cGMP regulations, ISO/IEC 17025 in relation to contract development and manufacturing.
In this role, you will have interaction with Clients, Regulatory Agencies, and Accrediting Bodies and will be responsible for advising operational colleagues of the importance of quality, accuracy and integrity in the provision of the inspection and testing services we provide.
Responsibilities:
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization. Diversity Statement:
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
Element has an opportunity for an experienced
Quality Manager II. Reporting to the Quality Director, Life Sciences, you are an essential member of the Life Sciences Business Unit Quality team and responsible for supporting the quality function across the Element Life Sciences laboratories, manage customer, accreditation and regulatory body relationships and drive standardization and best practice in cGMP/GLP Quality systems and processes.
The successful candidate will have a sound working knowledge of cGMP regulations, ISO/IEC 17025 in relation to contract development and manufacturing.
In this role, you will have interaction with Clients, Regulatory Agencies, and Accrediting Bodies and will be responsible for advising operational colleagues of the importance of quality, accuracy and integrity in the provision of the inspection and testing services we provide.
You will be involved in leading quality at the business unit level and will work closely with the Quality Director to ensure that Element quality policies, processes and procedures are effectively implemented. As a quality leader within Element, you will be capable of driving a culture of quality assurance and quality improvement, working closely with your operational colleagues and the wider Element quality community.
Responsibilities:
- Develop and ensure compliance with Element Quality system and processes related to the GMP/GLP scope of testing services
- Provide Quality support and GMP/GLP expertise to operational and divisional management and location quality management. Support in audit preparation and post audit activity implementation
- Support the Quality Director, Life Sciences planning and execution strategy to drive standardization of GMP/GLP quality techniques and technologies, quality and technical processes and procedures and advise on their continuing suitability based on industry experience and customer expectations
- Establish and maintain strong relationships with clients, regulatory authorities and accreditation bodies. Ensure proactive management of all relevant customer relationships working with the Quality Director, Life Sciences, the commercial team and peers
- Identify and implement best practice in quality, technical processes and the quality management system
- Promote the Quality Manager II role as the subject matter expert within Element and identify technical specialists (“go to colleagues”) for the various GMP/GLP activities and establish an effective internal network
- Support the regulatory training and development of colleagues involved in GMP/GLP testing in Element
- Work with the Quality Director, Life Sciences to establish an effective Quality community to share quality best practice across the business unit
- Ensure through personal continued professional development that changes in the technical, quality and regulatory landscape relating to GMP/GLP testing activities are anticipated and processes adjusted accordingly
- Establish, demonstrate and promote a continuous improvement mind set within the business unit quality community
- Participate and advise on adjustments to GMP/GLP quality procedures and processes, as necessary
- Promote Element’s technical and quality capabilities through participation in participation in industry organizations, industry conferences and through written technical papers
- Support the creation and maintenance of new policies, processes and procedures (quality and support procedures) related to all of Element’s GMP/GLP activities
Provide guidance and expert advice to management or other groups on technical, systems, quality, risk management or process-related business improvement aspects - Support development of a world-class service provision in relation to pharmaceutical and antimicrobial testing
- Provide leadership and representation of Element to third party organizations, customers, accreditation bodies / committees, suppliers / vendors
- Effectively desk review procedures to prepare GMP/GLP sites for 24/7/365 site audit readiness for all customers, regulatory agencies, and Quality
- System accreditation (e.g. ISO 17025) with detailed pre-audit reports as required by internal QMS and other assessment bodies.
- Conduct internal audits as required by QMS
- Travel within North America (approximately 30% dependent on location)
- Maintain high level of ethics in day to day operations and decisions.
- 10-15 years’ experience with clear evidence of building and leading successful teams
- Bachelor’s degree (or equivalent qualifications and experience) in a relevant scientific or engineering discipline
- Advanced knowledge of GMP in a contract development and manufacturing environment
- Strong problem-solving skills with in-depth Root Cause Analysis experience
- Highly proficient in reviewing, analyzing and charting quality KPI’s in Excel and for presentation to management
- Effective organizational and time management skills with the ability to multi-task and prioritize assignments or projects as required
- Excellent communication skills, with the ability to represent Element to clients, industry bodies and regulators in a positive and professional manner
- Ability to develop effective solutions for complex problems and support clients with their testing programs at a high level
- Ability to collaborate effectively in a dynamic, cross-functional matrix environment, effectively influencing colleagues, setting clear expectations, establishing accountability, monitoring progress and achieving agreed strategic goals
- Ability to quickly gain the trust and respect of colleagues, clients and senior leadership within Element
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Company Overview:
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 7,500 brilliant minds operating from 200 sites across 30 countries. Together we share an ambitious purpose to ‘Make tomorrow safer than today’.
When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.
While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.
Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.
All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.
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