Quality Lead for Zoetis Denmark ApS, Farum.
Be a part of a global market-leading company within animal health.
As our new Site Quality Lead, you will work closely with the Manufacturing Site Leadership, Engineering and R&D, but also global functions such as Global QSS, Quality Auditing, GMT etc.
A Glimpse of your workday
The Site Quality Lead role is accountable for leading all Quality functions at the Farum site including quality assurance, quality control, quality operations, and compliance. Product quality and the site’s regulatory compliance standing – maintaining a state of Inspection Readiness. The role achieves site and corporate quality objectives through leadership, development, and coaching of staff and assures systems and processes are in place to meet or exceed Zoetis and regulatory requirements. As such, the Site Quality Lead is designated as the Management Representative in accordance with ISO 9001.
The Site Quality Lead champions the Quality Culture and takes proactive steps to prevent any decay in the state of quality and compliance at the site. The role is accountable to ensure the site Quality Policy is understood, implemented and maintained at all levels of the site organization. The Site Quality Lead role is responsible for ensuring the independence and authority of the Quality unit is maintained and for ensuring adequately trained resources are available to support the quality system.
The Site Quality Lead role manage the day to day quality operations and is accountable for ensuring an annual site Quality Plan has been established; Standard Operating Procedures and instructions have been established; and, a plan for Quality Audits has been established and maintained.
The position also co-chairs the site management team (with the Site Lead) to drive continuous improvement and compliance objectives as well as prioritizing quality improvement initiatives. The Site Quality Lead uses data and metrics to drive continuous improvement in site quality systems as well as Product Quality. Additionally – the role is responsible for creating and executing the Site Quality Roadmap. The position is accountable for ensuring Management with Executive responsibility are informed and conduct the Management Review to evaluate the effectiveness of the quality system and alignment with the Quality Policy and Quality Plan.
The position reports to the Platform Quality Leader, located in US.
· Establishing / Reinforcing the Quality Culture on the Site;
· Implementation of Quality Standards
· Maintain Site Inspection Readiness. Promote Compliance Audit findings/remediation.
· Ensure that products are manufactured in compliance with Registration File (and appropriate Reg Bodies)
· Ensure Product Release is done within Regulatory Standards and pertinent Registration Files.
· Insuring QC Testing meets Regulatory Compliance and GMPs.
· Proactive Ownership of the Site Risk Assessment process.
· Oversee the development and implementation of the Quality Plan / Quality Road Map
· Share Leadership of Site Quality Councils and Metrics
· Develop metrics to deliver product and process improvement.
· Maintain the Supplier Quality program and vendor certification.
· Insure the Validation Master Plan is compliant and up to date. (Validation strategy and site compliance)
· Create and be accountable for the Site QA/QC Budget.
· Champion Leadership Development for the Site Quality Staff.
· Overall Site Product Portfolio Quality Stewardship owner and accountability.
· Facilitate agency inspection and notified body audits
Staff and Leadership Responsibilities
· Leadership Development / Coaching of Staff; Creation of Learning Organization
· Stewardship of the Quality Culture within the QA Function as well as the Site.
· Insure Training and Development plans are in place for all QA associates.
· Development of Site QA operations budget and resource planning for roll up to the Site Quality Budget.
· Strong Communication skills written and verbal
· Support the development of Quality goals and targets as part of the organization’s strategic plan.
Education, skills and ExperienceTo have success in this job the ideal candidate should hold at least a Science or Engineering BS and demonstrated significant leadership experience in a Quality Role in Animal Health / Human Health Medical Device and In Vitro Diagnostics.
In addition, Operations or Quality Experience in Medical Device as well as USDA and EU regulated work experiences is an advantage.
Good experience with Six Sigma and/or Lean Manufacturing and strong in ISO 9001 preferred.
It is required that you are fluent verbally and in writing in both English and Danish.
Who you are
You can lead in Change Management environment, and act as a Change Agent
As a passionate problem solver, you have a root cause analysis methodology
With a process-oriented mindset and a data and continuous improvement orientation, you are able to work well in a complex environment.
This is a unique and challenging job in a global market-leading company, where you will have opportunities to excel and expand your competencies together with highly skilled and committed colleagues.
You become part of an ambitious company with strong core values also regarding its workforce.
In Farum, we have a multidisciplinary and multicultural environment with more than 80 colleagues and 10 different nationalities, an informal work atmosphere with a willingness to help, and always room to have fun.
At Zoetis we are passionate about our customers and the animals in their care. We discover, develop and manufacture the world’s most innovative and effective products for animal health-medicines, vaccines, diagnostics, genetic tests, biodevices-and we are creating the next generation of integrated solutions and services to support this evolving industry. We know our people drive our success. Our colleagues are proud of our company culture and the meaningful role we play in caring for animals. The Zoetis Core Beliefs define the commitments we make to our colleagues, customers and stakeholders every day. They have guided the creation of our award-winning workplace and our proud position as a leading partner of choice in animal health.
Diversity, Equity & Inclusion
Our Colleagues Make the Difference, and we know their differences make Zoetis stronger. We strive to create an environment where each colleague feels valued and cared for and where we can be our best every day. Our Diversity, Equity & Inclusion (DE&I) focus and commitment begins with our leadership team of diverse backgrounds, experiences and ethnicities (50% of our executive team members are women), and it is demonstrated in our support of our colleagues and industry. Our Diversity, Equity & Inclusion Council, representing colleagues across locations, functions and communities, serve as ambassadors and champions for DE&I initiatives. In addition to the Diversity, Equity & Inclusion Council, Zoetis has six colleague resource groups that bring together colleagues who share similar backgrounds, experiences, or interests and work together toward goals aligned with our strategic business priorities.
Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a Best Place to Work for LGBTQ Equality, a 100 Best Company for Working Mothers, a Top Company for Executive Women, among many others.
For animals. For health. For you.
Read more about QA Site Lead Zoetis here!