Element Materials Technology

Head of Quality

Job Locations US-OR-Bend
ID
2021-7803

Overview

VR Analytical, Proud to be a part of Element has an opportunity for a Head of Quality to join our rapidly growing Life Sciences Group. The Head of Quality oversees and provides leadership for VR’s GMP compliance, Quality System and operations. They impart a vision of cultural excellence, and ensure quality improvement projects, at all levels, will meet or exceed internal and external customers’ needs and expectations.  This person helps drive our continued growth, commitment to high quality and success by driving and supporting implementation of strategic initiatives for improved efficiency, productivity and compliance.  The Head of Quality is an essential member of the management team. They work closely and collaboratively with Quality, Chemist and Leadership staff to complete challenging projects to accomplish organizational goals, provide ideas to improve efficiency at the group level, help guide our company into the future, and actively contribute to positive co-worker and customer relationships. Our ideal candidate is a very positive, energetic person that embraces challenges as opportunities, is an established leader, an expert communicator and top-notch team player. 

 

Responsibilities

  • Oversee all aspects of VR Analytical’s quality improvement efforts, such as developing and administering the processes, training and coaching employees, and facilitating change throughout the organization
  • Report on the state of the Quality System and compliance concerns to executive management, such as through monthly business reviews and quarterly Management Review Meetings
  • Report on the state of the Quality System and provide policy updates to staff
  • Direct solutions that reduce the costs of poor quality and compliance risks
  • Assess operational/compliance weaknesses, redundancies and inefficiencies and work with other leaders to incorporate process improvements (i.e. foster continual improvement) and review resource allocations
  • Participate in setting company direction and goals in conjunction with other department heads and ensure quality ambitions and business goals are aligned
  • Establish and impart the Quality Policy throughout the company
  • Establish quality procedures at all levels while minimizing direct and indirect costs
  • Communicate to executive management the importance and substance of compliance and quality objectives, and of management responsibilities of compliance
  • Develop Quality staff to be drivers of positive quality improvements and culture.  Includes all direct supervision responsibilities
  • Participate in the development and execution of onboarding and ongoing training for quality processes
  • Provide financial information on quality activities
  • Give presentations and write pieces on quality to promote VR’s marketable Quality System sophistication
  • Chair quality improvement teams
  • Monitor changing regulatory expectations, communicate them internally and integrate them into procedures
  • Facilitate and host customer and regulatory audits; communicate with audit contacts throughout the scheduling, execution, report and response phases, and ensure the customer qualification of VR is obtained and maintained
  • Review, approve, maintain and ensure compliance with contractual Quality Agreements
  • Facilitate FDA Regulatory Registration
  • Direct VR’s Quality System, which includes, but is not limited to, the following elements: laboratory investigations, nonconformances, deviations and CAPA program; internal/external audits; training program; equipment qualification; vendor qualification program; calibration and preventive maintenance program; document control; quality records maintenance; inspection and testing methods, defining and implementing quality metrics and compliance with 21 CFR Parts 11, 210, 211 and 820.

Skills / Qualifications

  • Bachelor’s degree or higher in a related scientific field, with 10+ years of hands-on experience in a QA role with increasing responsibilities in a pharmaceutical cGMP environment
  • Broad expertise of 21 CFR Parts 11, 210, 211 and 820 and the implementation of GMP principles, practices and procedures
  • Proven ability to be an exceptional leader, mentor, team player and decision maker.  Prior experience supervising staff required
  • Demonstrated ability to be a highly productive, self-motivated and self-directed team members
  • Exceptional written and verbal communication skills
  • Demonstrated change management skills and flexibility
  • Demonstrated experience in implementing and/or overseeing 21 CFR Part 11 compliance systems
  • Highly proficient in Microsoft Word and Excel, including advanced formatting, formula and chart creations
  • Passion for quality and culture
  • Project management experience a plus
  • Analytical chemistry background a plus

#LI-AL1

Company Overview

Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 6,500 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.

Diversity Statement

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: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

TIC Council Statement

Element is proud to be a full member of the Testing, Inspection & Certification Council (the “TIC Council”), an international association representing independent testing, inspection and certification companies. 

 

Members of the TIC Council must implement and abide by the TIC Council Compliance Code. Element has therefore issued an overarching Code of Conduct which is supported by our Compliance Programme. A copy of the Code of Conduct and more information about our Compliance Programme can be found in the Governance and Integrity section of www.element.com

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