Start Date: 1st of December / Hours: 40 hours per week (40% working from home is possible) / Location: Randstad
A Dutch biopharmaceutical company dedicated to advancing innovative vaccine development. They collaborate with national and international partners to improve global public health through the research, development, and production of vaccines for infectious diseases.
Position Overview: They are currently seeking an experienced and dynamic Quality Assurance Manager to lead our Quality Assurance team. The QA Manager will be responsible for maintaining the highest standards of quality and compliance throughout our vaccine development and production processes. This is a leadership role with six direct reports.
Key Responsibilities:
- Develop, implement, and oversee a comprehensive Quality Management System (QMS) in alignment with relevant regulatory standards and Intravacc's quality policies.
- Lead, mentor, and guide a team of six direct reports within the QA department, fostering a culture of quality, teamwork, and continuous improvement.
- Conduct internal and external audits, ensuring strict compliance with regulatory requirements, such as GMP, GLP, and GCP.
- Collaborate closely with cross-functional teams, including Research & Development, Manufacturing, Regulatory Affairs, and other stakeholders to embed a culture of quality and regulatory compliance throughout the product life cycle.
- Review and approve batch records, standard operating procedures (SOPs), and other quality-related documents.
- Lead investigations into quality incidents and deviations, implementing corrective and preventive actions (CAPAs) to address root causes effectively.
- Stay current with industry trends and changes in regulatory requirements to ensure Intravacc's continuous compliance and competitive edge.
Qualifications:
- Bachelor's or higher degree in a relevant scientific discipline.
- A minimum of 10 years of progressive experience in quality assurance roles within the biopharmaceutical or vaccine industry.
- Strong knowledge of regulatory requirements, including GMP, GLP, and GCP.
- Proven experience in managing and leading a QA team, with a demonstrated ability to inspire and develop direct reports.
- Exceptional communication, interpersonal, and leadership skills.
- Experience with regulatory submissions and inspections is a valuable asset.
Interview process: 1 stage interview process via TeamsStart Date: 1st of December / Hours: 40 hours per week (40% working from home is possible)
A Dutch biopharmaceutical company dedicated to advancing innovative vaccine development. They collaborate with national and international partners to improve global public health through the research, development, and production of vaccines for infectious diseases.
Position Overview: They are currently seeking an experienced and dynamic Quality Assurance Manager to lead our Quality Assurance team. The QA Manager will be responsible for maintaining the highest standards of quality and compliance throughout our vaccine development and production processes. This is a leadership role with six direct reports.
Key Responsibilities:
- Develop, implement, and oversee a comprehensive Quality Management System (QMS) in alignment with relevant regulatory standards and Intravacc's quality policies.
- Lead, mentor, and guide a team of six direct reports within the QA department, fostering a culture of quality, teamwork, and continuous improvement.
- Conduct internal and external audits, ensuring strict compliance with regulatory requirements, such as GMP, GLP, and GCP.
- Collaborate closely with cross-functional teams, including Research & Development, Manufacturing, Regulatory Affairs, and other stakeholders to embed a culture of quality and regulatory compliance throughout the product life cycle.
- Review and approve batch records, standard operating procedures (SOPs), and other quality-related documents.
- Lead investigations into quality incidents and deviations, implementing corrective and preventive actions (CAPAs) to address root causes effectively.
- Stay current with industry trends and changes in regulatory requirements to ensure Intravacc's continuous compliance and competitive edge.
Qualifications:
- Bachelor's or higher degree in a relevant scientific discipline.
- A minimum of 10 years of progressive experience in quality assurance roles within the biopharmaceutical or vaccine industry.
- Strong knowledge of regulatory requirements, including GMP, GLP, and GCP.
- Proven experience in managing and leading a QA team, with a demonstrated ability to inspire and develop direct reports.
- Exceptional communication, interpersonal, and leadership skills.
- Experience with regulatory submissions and inspections is a valuable asset.
Interview process: 1 stage interview process via Teams