About this role
The team is seeking a Senior Executive Quality Assurance – Biologics to oversee quality assurance activities related to biologics manufacturing. This role is essential in ensuring compliance with current Good Manufacturing Practices (cGMP), regulatory guidelines such as FDA, EMA, ICH, and maintaining company quality standards.
Key Responsibilities:
- Provide QA oversight for biologics manufacturing operations, including upstream, downstream, and fill-finish processes.
- Manage training programs to ensure all staff are compliant with quality standards.
- Oversee document management and Quality Management System (QMS) activities.
- Handle development quality assurance activities to ensure product integrity and compliance.
- Collaborate with cross-functional teams to address quality issues and implement corrective actions.
Required Skills & Qualifications:
- Bachelor's degree in Life Sciences, Pharmacy, or a related field.
- Strong knowledge of cGMP, FDA, EMA, and ICH guidelines.
- Proven experience in quality assurance within the biologics sector.
- Excellent communication and leadership skills.
- Proficiency in quality management systems and documentation practices.
Experience:
- Minimum of 5 to 8 years in Quality Assurance, specifically in biologics manufacturing or related fields.
What we offer:
- Opportunity to work in a dynamic and innovative environment.
- Professional development and career advancement opportunities.
- A collaborative team culture focused on quality and compliance.
Applications are read by our talent team, usually within two working days.
If you look like a fit we will call you, and you will hear from us either way.