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Director, Quality Engineering

Bachem is a listed technology-based company focused on peptide chemistry. The company provides a full range of services to the pharma and biotech industries. It specializes in the development of innovative, efficient manufacturing processes and the reliable production of peptide-based active pharmaceutical ingredients. A comprehensive catalog of biochemicals and exclusive custom syntheses for research labs complete the service portfolio. Headquartered in Switzerland with subsidiaries in Europe, the US and Asia, the group has a global reach with more experience and know-how than any other company in the industry. Towards its customers, Bachem shows total commitment to quality, innovation and partnership.

In order to continue our organic growth, we are constantly looking for talent.

Your Responsibilities

The Quality Engineering (QE) Director is responsible for overseeing Quality Engineering teams who

support validation and qualification of equipment, facilities/utilities and cleaning validation activities for

API manufacturing at both Bachem America’s locations (Vista & Torrance).  The incumbent will provide

leadership and guidance to the QE managers and QE employees. The QE Director will lead the

harmonization of validation processes at both Bachem sites. This position is responsible for managing,

developing and implementing validation processes to ensure products meet the appropriate regulatory

agency’s validation requirements, internal company standards and current industry practices. This

position will work in close cooperation with Manufacturing, Engineering and other functional areas in

managing validation activities under the QE scope of work.  Responsible for presenting validation

practices during the regulatory agencies and customers audits.

 

Your Tasks

  • Hire, manage, and develop teams to support validation activities at both locations
  • Manage continued growth, development, and retention of the team
  • Set strategic direction for the QE organization
  • Responsible for making key decisions and formulating policies that are aligned with strategic objectives of the QE function and Bachem
  • Collaborate with Manufacturing, Engineering, QA and other functional areas in managing validation activities under the QE scope of work
  • Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases
  • Develops key performance metrics that measure the effectiveness of the QE organization
  • Develop validation master plan (VMP) to assure compliance with regulatory requirements
  • Oversee or independently develop a cleaning validation strategy for equipment and parts. Develop and execute or approve cleaning validation protocols and generate validation reports
  • Oversee or independently plan and execute validation studies for equipment, facilities/ utilities and cleaning
  • Write validation protocols, validation final reports and Standard Operating Procedures (SOPs), and technical reports
  • Draft or review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures
  • Conduct and document investigations related to validation activities
  • Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
  • Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per FDA, and other regulatory agencies requirements. Contribute to GMP systems improvements

 

Your Profile

 

  • Bachelor’s Degree in science related field (engineering, chemistry, or equivalent)
  • Minimum of 10 years pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities) including experience in writing and execution of protocols, reports and operating procedures
  • At least 5 years of experience in people management and leadership
  • Experience in drug GMP manufacturing
  • Strong knowledge of GMPs, FDA & EU guidelines/requirements related to validation
  • Experience with root cause analysis, failure mode analysis and analyzing complex technical problems. Possess sound technical judgement
  • Experience in writing standard operating procedures and technical reports
  • Excellent written and oral communication skills
  • Proficient computer knowledge, including Microsoft Word, Excel and PowerPoint
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment

 

Preferred:

  • Master’s Degree in science related field
  • Six Sigma Green or Black Belt

 

We Offer

You will be part of a motivated team overseeing the entire development cycle of respective APIs. If you are

looking for a new challenge and want to join a motivated team in an internationally renowned company,

you should seize this opportunity.

 

 

 

 


 

 


Nearest Major Market: Los Angeles

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