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Quality Assurance Director

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Date: Oct 4, 2021

Location: Bethlehem, PA, US, 18017

Company: Lubrizol Corporation

Lubrizol Life Sciences Health's CDMO business is the leading CDMO for complex formulation development for the pharmaceutical industry, with over 20 years of successful experience and a solid base of clients ranging from the world’s largest pharmaceutical and biotech companies to small VC backed start-ups. As a member of the LLS Health team, you will be working for a company that is engaged in important, exciting, and socially relevant projects. LLS Health is a fast-paced environment that features a variety of projects, technical challenges, and opportunities for growth. To learn more about us, visit www.particlesciences.com and https://www.lubrizol.com/Life-Sciences.

 

The Quality Assurance Director is responsible for strategic oversight and leadership to QA, to ensure project objectives are met to a high-quality standard and according to commitments while ensuring current Good Manufacturing Practices (cGMPs) compliance and compliance to appropriate regulations. The primary responsibilities of this position include providing direction for programs, processes and team members of the department, as well as setting the tone for compliance and on time delivery of department deliverables.

 

Key Responsibilities include, but are not limited to:

  • Responsible for staffing and overseeing training, effective execution of responsibilities, professional development of employees and conducting performance reviews
  • Outlines and executes on department and business objectives, identifying continuous improvement initiatives, monitors progress of deliverables, and provides support to staff to ensure success 
  • Directs the batch record review and lot disposition activities to ensure product delivery in compliance with applicable regulatory submissions and approvals and within prescribed timelines
  • Provides strategic oversight and leadership to client representatives to ensure project objectives are met to a high-quality standard and according to commitments
  • Responsible for the Quality Metric review process, assesses data for adverse trends, develops solutions and oversees implementation related to area 
  • Facilitates QA support and works closely with other functional units including Manufacturing, Validation, Facilities Engineering, and Quality Control to assess and resolve quality issues with regards to the facility and products manufactured 
  • Resolves and assists in solving compliance and customer issues
  • Develops and implements procedures, programs and policies that support GMP operations and overall compliance strategy
  • Ensures quality investigations and corrective and/or preventive action plans to resolve potential product quality and compliance issues are appropriately implemented
  • Continuous review of all systems and procedures (SOPs) for efficiency, best practices and regulatory compliance improvements and adherence with site policies.
  • Works with senior management to initiate new client proposals and projects. This includes analyzing client proposals for resource allocation and QA costs generated by Business Development

 

Minimum Qualifications:

  • BA/BS degree, preferably in a scientific field
  • 10+ years of relevant experience in pharmaceuticals, preferably within a Quality role
  • Must have previous leadership experience, including performance management
  • Comprehensive and practical working knowledge of applicable GMP regulations, ICH guidelines, FDA guidelines, USP, EP, JP and other applicable regulations and guidance
  • Knowledgeable and/or exposure to sterile manufacturing processes with exposure to contract manufacturing a plus.
  • Excellent communication and interpersonal skills required
  • Strong attention to detail and organization skills required
  • Proven technical writing and editing skills

 

 

Lubrizol offers competitive benefits: Medical, Dental, Vision, 401(k), Age-Weighted Defined Contribution Planand so much more!

Visit http://benefits.lubrizol.com to learn more.

 

 

Lubrizol Life Science Health's CDMO business is located in Bethlehem, PA, part of the Lehigh Valley region of Pennsylvania. Lehigh Valley includes the cities of Allentown, Bethlehem and Easton. The region is slightly over an hour to both Philadelphia and New York City, which places you right in the action. Buzzing with business, culture, knowledge and entertainment, the Lehigh Valley is a vibrant place for people of all ages and walks of life to live, learn, work and play.  This region offers a little bit of everything for everyone - ethnically-diverse communities, affordable housing, award-winning schools and universities, world-class healthcare, ski resorts, museums, casinos, shopping, restaurants, sports and nightlife. From the yearly Musikfest festival, to skiing in the Poconos, to hiking or biking through the many state parks, you can make it happen right here in the Lehigh Valley.

 

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.

Do You Need Assistance?

Please let us know if you need an accommodation to proceed with your application for a posted job, or with any other aspect of the interview or assessment process.  You can either call 440-943-4200 and ask for Talent Acquisition or send an email to talentacquisition@lubrizol.com. Please note that this phone line and email address are not to be used for checking on the status of an already submitted application and not to be used by third party recruiters.


Nearest Major Market: Allentown

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