Share this Job

Sr. Manager Quality Assurance Life Sciences, Medical

Apply now »

Date: Aug 3, 2022

Location: Brecksville, OH, US, 44141 Victor, MT, US, 59875 Corona, CA, US, 92879 Franklin, WI, US, 53132

Company: Lubrizol Corporation

90322 

The Lubrizol Corporation, a Berkshire Hathaway company, is a market-driven global company serving customers in more than 100 countries. We own and operate manufacturing facilities in 17 countries, as well as sales and technical offices around the world. Through our global sales and manufacturing networks, we are able to deliver the products and services our customers need, where and when they need them.

 

 

Job Summary:

  • The Sr. Manager of Quality Assurance for Lubrizol Life Science (LLS) Health is accountable for developing and governing quality assurance (QA) policies and processes for primarily the LLS health medical contract manufacturing sites. Working with the commercial, manufacturing, and quality control (QC) teams, this role will establish QA policies and processes that are designed to prevent instances of product defects and to support the “culture of quality” in the operations and manufacturing of LLS products and ingredients. This role interacts with internal stakeholders, customers, and external organizations and agencies to align the quality goals and activities of the GBU with the applicable product and manufacturing quality standards.  

 

Essential Duties & Responsibilities:

  • Establish and govern quality policies and assurance systems for medical contract manufacturing operations and businesses.
  • Ensure quality systems operate effectively and meet customer, agency and company requirements and goals and that they are continuously improved.
  • Act as the externally facing Quality Leader for LLS Health business and operations, leading the negoatiation and finalization of customer quality agreements, and representing Lubrizol to government agencies (FDA), customers, and industry bodies.
  • Lead the definition and implementation of systems, tools, and processes that enable effective operation and continuous improvement of quality performance and overall organizational efficiency and effectiveness (ERP, QMS, MES, and similar).
  • Directly manage the Quality Teams (direct reports) from Corona, Montana, Franklin, and BMT sites in Europe.
  • Schedule, prioritize and conduct supplier audits in support of quality assurance practices and “culture of quality” for LLS sourcing activities.
  • Act as the Quality subject matter expert and input into creation of business strategy (strategic initiatives, product strategy, acquisition strategy, quality and regulatory policy and strategy).

 

Skills, Experience, and Qualifications:

  • BS Degree or higher in a scientific field (chemistry, biochemistry,biology, engineering)
  • Minimum of 10 years experience building and managing quality systems that meet FDA regulations for medical devices.
  • Minimum 7 years of direct people leadership with progressive responsibility.
  • Demonstrated success negotiating with and successfully managing audits with customers and government agencies.
  • Strong communication and presentation skills with demonstrated ability to present to and successfully advocate for institutional change;
  • Strong analytical and problem solving skills;
  • Comfortable with and able to influence senior leadership;
  • Able to lead interdisciplinary teams (HSE, PSCD, Legal, Finance etc);
  • Travel up to 25% of time. 
  • Experience with defining, implementing and operating ERP, digital QMS, digital manufacturing and batch execution systems is preferred.

 

#LI-JL1

While headquartered in the United States, Lubrizol is truly a global specialty chemical company.  We have a major presence in five global regions and do business in more than 100 countries. Our corporate culture ensures that Lubrizol is one company throughout the world, but you will find each region is a unique place to work, live and play.

 

Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.


Nearest Major Market: Cleveland

Job Segment: QA, Quality Assurance, QC, Quality Manager, ERP, Technology, Quality