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Director, Quality

Avantor
Carpinteria, United Statesfull_timeVerifiedPosted 7 Jun 2024
💰 $262,000/yr($157,000/yr$262,000/yr)

About the role

The Opportunity:

Avantor is looking for a Director, Quality to join our NuSil team supporting manufacturing of high purity silicone products. In this role, you will provide leadership, technical, and strategic guidance, supporting quality operations for chemical manufacturing of high-purity silicone products.

This role will be a full-time, onsite position based out of our Carpinteria, CA facility.  You will also provide support to manufacturing sites in Bakersfield, CA, and Irving. TX.  If you are a transformative leader seeking an exciting opportunity to drive quality initiatives – let’s talk!

What we’re looking for  

  • Education: B.S. in science or quality related discipline.  Prefer an advanced degree or MBA.

  • Experience: 10+ years of experience in a combination of Quality and Regulatory roles in a regulated cGMP manufacturing environment.

  • 7+ years of experience in managing others and managing multi-sites is preferred.

  • Preferred experience in advanced silicone industry; chemical manufacturing experience is a plus.

  • Experience in quality systems, quality assurance, and quality control.

  • Extensive knowledge in relevant regulations (FDA cGMPs: 21CFR Parts 820, 210, 211, ICH Q7, EMA GMPs, and other international regulations), ISO 9001, and ISO 13485.

  • Continuous improvement certification, certified auditor, ASQ certifications, etc. are preferred.

  • Ability to travel 25%.

  • A proven leader, in a manufacturing environment, that can build and mature Quality organizations, systems and risk-based processes to achieve business objectives.

  • A quality, compliance and business minded individual that values a growth mindset, partnerships, and collaboration.

  • Excellent communication, interpersonal and people management skills.

  • Ability to effectively interact with all levels of the organization, regulators, customers, and suppliers.

  • Demonstrated knowledge on the application of regulated quality and production risk-based processes.

  • Strong analytical and problem-solving skills.

How you will thrive and create an impact  

  • As part of the Avantor’s Quality Operations leadership team, lead the site Quality teams to establish, and achieve, a vision, strategic plans, initiatives, and annual objectives.

  • Develop and cultivate high performing Quality teams, Management Systems, and cross-functional partnerships.

  • Ensure compliance to the applicable regulatory requirements, effectiveness and efficiency of the Quality Management System, Quality Assurance and Quality Control programs across the sites. Lead harmonization efforts to improve standardization.

  • Ensure sites are driving continuous improvement, via the QMS and ABS, to achieve Quality compliance, performance targets, and business objectives.

  • Provide leadership, guidance, and expertise on quality matters, to include product field actions and complaints, external audit compliance and compliance requirements.

  • Proactively communicate with top management, customers, regulatory agencies (FDA, DEA, etc.) and internal stakeholders on Quality strategy plans and annual objective progress, regulatory compliance, product performance, and improvement initiatives.

  • Performs other duties as assigned.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today!

Pay Transparency:

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Avantor

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