Similar posts
Quality Assurance Manager
- Contract
- Good Manufacturing Practice (GMP)
- United States
This vacancy has now expired. Please see similar roles below...
Quality Assurance Manager - Contract - Gaithersburg, Maryland MD
Proclinical is seeking a dedicated professional to manage and enhance quality processes across international operations in the biotechnology industry.
Primary Responsibilities:
The successful candidate needs to be a dedicated professional in order to manage and enhance quality processes across international operations in the biotechnology industry. The role focuses on leadership, oversight of teams, and establishing collaborative relationships with Contract Manufacturing Organizations (CMOs).
Skills & Requirements:
- Bachelor's degree in Sciences or Engineering.
- Substantial Quality industry experience is a necessity.
- Working knowledge of relevant EU and global GMP regulations and ICH, ISPE standards/guidelines.
- Experience with CMOs, CLOs, vendors, and regulatory inspections is beneficial.
- Knowledge of computerized systems, automation, operations and manufacturing/testing within the biotechnology industry.
The Quality Assurance Manager's responsibilities will be:
- Lead and oversee teams managing CMO sites to ensure adherence to approved policies, regulations, and quality agreements.
- Review and approve cGMP documentation, support quality investigations, manage CAPA for CMO activities, and coordinate approval of all changes made to manufacturing.
- Establish and maintain collaborative relationships with CMOs.
- Oversee timely reporting and closure of Quality events, and proactively monitor the performance of CMOs.
If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado on a.maldonado@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
INDCQA
Related jobs
€75000 - €85000 per annum
Marburg (35037), Deutschland
Hobson Prior is seeking a Compliance Expert for Supply Chain Processes.
Highly Competitive Salary
Philadelphia, USA
Proclinical is seeking a dedicated and skilled QC Cell Therapy Supervisor. This is a permanent position located in Philadelphia, PA.
Highly Competitive Salary
New Haven, USA
Proclinical is actively seeking a Quality Assurance Technician for Medical Device Development. This is a contract role located in New Haven, CT.