Quality Manager

Location: Massachusetts  |  Massachusetts  |  United States
Sector: Life Sciences
Consultant: Chris Hutchinson
Job Reference: HQQMUSA
Salary: £63300 - £87900
Job Status: Permanent / Full Time

My client is seeking a Quality Manager professional to support the company’s QA Compliance program. As part of the Supplier Quality Management, the successful candidate will perform a broad range of external and internal audits and take part in the development and improvement of existing Quality Systems to ensure the QMS operates in compliance with applicable regulations, guidelines, and management expectations. In addition, the candidate will participate in sustaining inspection readiness and support continuous QA improvement, among other administrative tasks.

REQUIRED COMPETENCIES

A bachelor’s degree with a minimum of 8 years’ experience working in an environment subject to FDA and International Health Agency regulations and guidelines.

Minimum of 5 years of progressive, challenging QA/QC experience in pharmaceutical, biotech or medical device industries.

Minimum of 3 years of internal and/or external GxP auditing experience.

Current working knowledge interpreting and implementing United States Code of Federal Regulations, ICH Guidelines, EU regulations, and other local government regulatory requirements governing cGMP and GLP operations.

Must be able to demonstrate ability to evaluate and apply compliance requirements and guidelines to applicable situations.

Experience in the conduct and reporting of audits, and the translation of findings into corrective action plans that mitigate risks to the company.

Preferred Qualifications

Certification as a CQA Auditor, CQE, etc.

BA/BS or advanced degree in Biological Sciences or related fields.

Advanced working knowledge of Health Agencies GLP/GCLP/GCP regulations and guidelines, including 21 CFR Part 11, and their appropriate application to various situations.

Advanced experience leading GxP and GCLP audits in a variety of categories both domestically and internationally.

Experience with allogeneic and autologous Gene/Cell Therapy Products

Experience in Quality Operations oversight of external CxOs at a virtual company.

The company is looking to pay $90,000 up to $125,000 with a very generous bonus  

If you are interested in this please get in touch and send your CV, we are looking to interview candidates as soon as possible.