Quality Assurance Manager – New Jersey
Global Life Science Hub is partnered with an innovative biopharmaceutical company dedicated to developing novel medicines to address unmet medical needs. With multiple FDA approvals and a focus on various therapeutic areas, including oncology, and infectious diseases, this company has made significant strides in developing small-molecule and biological drug candidates.
They are about to triple their production with highly ambitious growth plans to double in size in the next 2.5 years. Due to such critical growth, we are now searching for a Quality Assurance Manager to ensure that the manufacturing operations have appropriate QA oversight.
- Supervise comprehensive and compliant investigations, including Deviations and CAPAs.
- Conceptualize, initiate, oversee, and execute enhancements to quality systems and processes.
- Ensure full compliance with regulatory cGMP requirements in all operations.
- Draft, review, and authorize SOP system documents to ensure adherence to cGMP standards, as needed.
- Manage the review and approval of raw materials, components, manufacturing documents (e.g., standard formulas, test analyses, batch production records, and batch packaging records) for release.
- Oversee the review and approval of quality control documents, including quality specifications and testing standards.
- Provide supervision and guidance to QA staff.
- Monitor the effectiveness of Quality Systems by developing metrics such as batch record errors, training deviations, etc., and conducting trend analysis for management review, while also escalating issues and driving resolutions.
- Conduct qualification audits of vendors/suppliers.
- Participate in deviations and OOS result investigations.
- Ensure a comprehensive root-cause analysis and implement corrective and preventive actions.
- Plan and facilitate Quality Review Board meetings.
- Perform other required or assigned functions.
- Adhere to all company policies and standards.
- Possession of a Bachelor’s or Master’s degree in Life Science or a related field.
- A minimum of 10 years of pertinent experience in the pharmaceutical quality assurance domain
- At least 3 years of experience in a direct supervisory capacity.
- Proficiency in GMP document review, Quality Management System maintenance, and quality auditing.
- Familiarity with the requirements and procedures associated with document control and quality assurance.
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com