Quality Assurance Release Manager

Torrance, CA
Jun 26, 2022
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time

The Swiss based Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of pepTides and oligonucleoTides. As a full service provider Bachem offers products for clinical development and commercial applications as well as a comprehensive catalog and exclusive custom synthesis. With 50 years of experience and subsidiaries in Switzerland, the United States, the United Kingdom and Japan, Bachem is the partner of choice for the biotech and pharma industry worldwide.
Bachem. Leading Partner in Tides

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

Your Responsibilities

The Quality Assurance Release Manager is responsible for operations related Quality Assurance activities including review and approval of GMP documents and release of GMP materials. In conjunction with the Director of Quality Assurance and VP of Quality, this individual ensures manufacture of drug substances in compliance with FDA and international regulatory requirements for research, pre-clinical, clinical and commercial Active Pharmaceutical Ingredients (APIs).

Your Tasks

  • Timely release of GMP materials
  • Review and/or approval of technical protocols and reports
  • Review and/or approval of quality records e.g. deviations, investigations, CAPA’s
  • Ensure GMP compliance and continuous improvement of BTO’s quality system
  • Write/review/approve standard operating procedures (SOPs), specifications, etc.
  • Support customer & regulatory audits. Participate in responses to audit observations
  • Review and/or approval of trending data
  • Review and/or approval of Change Controls
  • QA representative in project teams e.g. harmonization of systems and processes across Bachem sites, implementation of new systems or processes

Your Profile

  • Bachelor’s Degree in Science related field, Chemical Engineering, Biology or equivalent
  • Minimum of 5 years’ experience in a GMP/regulated industry
  • Minimum of 3 years in QA management position
  • Experience in GMP manufacturing environment, Quality Assurance, Quality Control
  • Experience with 21 CFR Parts 210, 211, ICH Q7
  • Experience with GMP document control
  • Experience in both internal and external auditing
  • Ability to work with regulatory agencies
  • Strong technical writing skills
  • Excellent written and oral communication skills
  • Basic 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
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one’s time
  • Communicate effectively and ability to function well in a team environment

Candidates for positions as US employees of Bachem Americas, Inc. (“Company”) must be in the process of or fully vaccinated against the COVID-19 virus and provide the Company with proof of vaccination as a condition of employment, except for U.S. employees who request and qualify under applicable law for disability and religious accommodation from the COVID-19 vaccine mandate. An applicant who receives an offer of employment from the Company for a position as a U.S employee will be required to provide proof of vaccination status, or request and receive a disability or religious accommodation for which the applicant is entitled under applicable law, before their first day of employment or any later deadline specified by the Company in the offer letter. The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regard to an individual’s disability, religion or on any other basis prohibited by law.