QA Manager

ONE NUCLEUS; Town Of Cambridge; Remote; AUD 90,000 - 110,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a dedicated QA Manager to join their team on a remote basis in Australia. This critical role will maintain oversight and ensure quality compliance of commercial drug substances and products during the maternity leave of the CMO. Candidates need proven experience in Quality Assurance, CMO oversight, and a relevant scientific degree.

Qualifications

• Proven industry experience in pharmaceutical Quality Assurance, CMO oversight, or in-plant GMP pharmaceutical manufacturing.
• A working knowledge and practical experience with biologics.

Responsibilities

• Oversee cGMP activities and processes for commercial drug substances.
• Provide QA oversight for technology transfers of commercial products to CMOs.
• Participate in CMO Business Review Meetings.

Skills

Experience in pharmaceutical Quality Assurance

Knowledge of cGMP activities

Ability to conduct regulatory inspections

Education

Relevant degree in a scientific discipline

Job description

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:

• Oversee cGMP activities and processes for commercial drug substances, intermediates, and finished drug products manufactured by CMOs, supported by line management.
• 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.

Role Requirements:

• 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.

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements.