Pharmaceutical QA Manager

Job Description

We are seeking a motivated Pharmaceutical QA Manager to oversee quality assurance processes in our Luton facility. The successful candidate will be responsible for ensuring compliance with regulatory requirements and fostering a culture of quality within the organization.

Responsibilities

• Champion a culture of continuous improvement in quality processes.
• Monitor industry trends and regulatory updates to keep the company compliant.
• Engage in risk management practices to mitigate quality threats.
• Coordinate with suppliers to ensure quality standards are maintained in the supply chain.
• Manage internal QA personnel and support their ongoing development.
• Review and approve all quality documentation and protocols.

Requirements

Education

• Bachelor's degree in Pharmaceutical Sciences or related field
• Master's degree in Quality Assurance is preferred

Experience

• 5+ years of experience in quality control within pharma or biotech

Technical Skills

• Data Analysis
• Documentation Management

Soft Skills

• Negotiation
• Teamwork

Certifications

• ISO 9001 Lead Auditor
• GMP Certification

Languages

• English: Fluent

Advantageous

• Knowledge of regulatory submission processes: Experience in preparing submissions for regulatory agencies.
• Familiarity with clinical trial regulations: Understanding of the regulations surrounding clinical trials and studies.

Benefits

• Comprehensive health and wellness benefits
• 401(k) retirement plan with company match
• Flexible working environment
• Employee assistance programs

Company Culture

• Innovation: Fostering an environment where ideas are welcomed and innovation is celebrated.
• Continuous Improvement: We actively seek out ways to improve processes and systems.
• Diversity and Inclusion: We value diverse perspectives and strive for an inclusive workforce.