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Program Manager, Quality Assurance BSD

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.

Your Responsibilities

The Program Manager fulfills a critical role for the Central Function Quality Systems group. This individual will be responsible for assisting with the development/ harmonization of Quality Systems at Bachem US sites and subsequent maintenance and oversight of these systems. This position will collaborate with QA and other team members at sites in the US and Europe to implement different modules of MasterControl, an electronic quality management system (or other electronic tracking tools). This position will also assist with preparing the US sites for regulatory inspections and conducting audits on behalf of Bachem America sites. The incumbent will assist with developing metrics and issuing reports to assess the health of Bachem US quality systems.

 

 

Your Task

·         Develop metrics for Quality Systems in support of management review and various quality reports

·         Assist with creation of shared Quality Systems documents for Bachem Americas sites to achieve harmonization

·         Assist with implementation of different modules of Master Control software at Bachem US

·         As part of the Central Function Quality System team you may be required to assist with maintenance/oversight of some of the following Quality 

          Systems:

·         Quality Event Reporting

·         Document Management System

·         Change Control/Equipment Change Control

·         Data integrity program

·         Supplier Quality program

·         Material Qualification Program 

·         Internal audit program

·         External audit program

·         Annual Product Review

 

Your Profile

 

Required:

·         Bachelor’s Degree in a science related field – Chemistry, Biology or equivalent

·         Minimum of 5 to 8 years of experience in quality assurance

·         Extensive experience in cGMP manufacturing, Quality Control, or Quality Assurance

·         Experience in writing standard operating procedures, specifications and technical reports

·         Experience conducting audits

·         Experience with the Material Qualification process

·         Experience in developing quality system metrics

·         Technical writing experience

·         Excellent written and oral communication skills

·         Excellent computer skills, including Microsoft Word, Excel and PowerPoint and Access

·         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

·         Detail oriented with the ability to troubleshoot and resolve problems

·         Ability to work independently and manage one’s time

·         Ability to interact well with co-workers, customers, regulatory agency auditors and senior management

·         Communicate effectively and ability to function well in a team environment

 

Preferred:

·         Master’s Degree in Science related field

·         Experience with Master Control or other electronic quality management system

·         Lean or six-sigma Green and/or Black belt certification

 

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: San Diego

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