Quality Assurance Manager
Posted 6 days ago by Hyper Recruitment Solutions
£75 Per hour
Inside
Remote
England, United Kingdom
Summary: Our client, a leading pharmaceutical company, is looking for a QA Manager to oversee CMO activities during the maternity leave of the permanent CMO manager. This remote role requires one day on-site per quarter and focuses on ensuring the quality and compliance of commercial drug substances and products. The position is an initial 12-month contract classified as inside IR35 via an Umbrella company.
Key Responsibilities:
- Oversee cGMP activities and processes for commercial drug substances, intermediates, and finished drug products manufactured by CMOs.
- Provide QA oversight for technology transfers of commercial products to and between CMOs.
- Offer QA support for regulatory agency inspections at CMOs as necessary.
- Participate in CMO Business Review Meetings and facilitate the resolution of deviations, non-conformances, and other batch-related quality issues with CMOs to ensure product compliance.
Key Skills:
- Relevant degree in a scientific discipline.
- Proven industry experience in pharmaceutical Quality Assurance, CMO oversight, or in-plant GMP pharmaceutical manufacturing.
- A working knowledge and practical experience with biologics.
Salary (Rate): £75.00/hr
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: inside IR35
Seniority Level: undetermined
Industry: Other
Our client, a leading company in the pharmaceutical industry, is seeking a dedicated QA Manager to join their team on a remote basis, with 1 day per quarter on site. This role is designed to maintain CMO oversight and associated activities during the maternity leave of the permanent CMO manager. As the QA Manager, you will play a crucial role in ensuring the quality and compliance of commercial drug substances and products. This is an initial 12 month contract, inside IR35 via an Umbrella company.
KEY DUTIES AND RESPONSIBILITIES: Your duties as the QA Manager will be varied; however, the key duties and responsibilities are as follows:
- As the QA Manager you will oversee cGMP activities and processes for commercial drug substances, intermediates, and finished drug products manufactured by CMOs, supported by line management.
- As the QA Manager you will provide QA oversight for technology transfers of commercial products to and between CMOs.
- As the QA Manager you will offer QA support for regulatory agency inspections at CMOs as necessary.
- As the QA Manager you will participate in CMO Business Review Meetings and facilitate the resolution of deviations, non-conformances, and other batch-related quality issues with CMOs to ensure product compliance.
ROLE REQUIREMENTS: To be successful in your application to this exciting role as the QA Manager, we are looking to identify the following on your profile and past history:
- Relevant degree in a scientific discipline.
- Proven industry experience in pharmaceutical Quality Assurance, CMO oversight, or in-plant GMP pharmaceutical manufacturing.
- A working knowledge and practical experience with biologics.
Key Words: CMO Manager / pharmaceutical Quality Assurance / cGMP / technology transfer / regulatory inspections / biologics / commercial drug substances / project management / risk management / compliance / patient safety
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.