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Manager Quality Assurance and Regulatory Affairs

Date: Nov 5, 2021

Location: South Haven, MI, US, 49090

Company: W. R. Grace & Co.

 

Requisition ID: 19256

Built on talent, technology, and trust, Grace is a leading global supplier of catalysts and engineered materials. The company’s two industry-leading business segments—Catalysts Technologies and Materials Technologies—provide innovative products, technologies, and services that enhance the products and processes of our customers around the world. Grace employs approximately 3,900 people in over 30 countries.

 

Job Description

This position, under the direction of the Corporate Compliance Manager with dotted reporting line to Site Manager, is responsible for all QA, RA and QC functions at the site.   This position serves as the QA expert on site.  

  • Ensures site compliance with cGMP and applicable state, federal, and global regulations. Manage Quality Systems to assure compliance to all applicable regulations by proactively interpreting regulatory and compliance requirements, establishing and maintaining quality systems for South Haven. 
  • Directs Quality Control Department to assure that all raw material, in-process, finished product, and stability testing is completed in a timely manner.
  • Directs Quality Assurance Department to assure that all aspects of South Haven operations are audited and validated. Manages supervisors and professional staff who perform external vendor and internal audits, training, complaint and deviation investigation, and host third party, government agency and client audits. Ensures timely disposition of finished product.
  • Reviews proposed regulations and makes recommendations for implementation.
  • Plans, directs, and administers departmental resources.  Prepares budgets and ensures budget goals are attained. 
  • Evaluates performance of individuals in department.  Prepares and implements development/succession plans. 

Required Skills

  • Demonstrated ability to manage and lead professional laboratory staff in order to achieve goals.
  • Demonstrated ability to evaluate and resolve complex technical problems.
  • Broad based knowledge of pharmaceutical QA/QC, manufacturing processes, and regulatory requirements

Required Experience

  • BA/BS in a scientific discipline, such as Chemistry, Microbiology, or Biochemistry plus 7 years relevant experience OR
  • MS plus 5 years relevant experience OR
  • Ph.D. plus 3 years relevant experience
  • Knowledge of cGMP and/or pharmaceutical industry experience       
  • Proven track record of strong communications and leadership skills           #WRGRACE

 

 

Grace is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Grace via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Grace. No fee will be paid in the event the candidate is hired by Grace as a result of the referral or through other means.

 

EOE Statement:  W. R. Grace & Co. is committed to creating a diverse environment and is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other legally protected status.

 

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation.


Nearest Major Market: Kalamazoo