Director of Quality - Berlin, Deutschland - Barrington James

Barrington James

Geprüftes Unternehmen

Berlin, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Job Type
Permanent
Emp Type

- full-time

Expertise
QA / RA
Salary Type
Annually
Salary
Negotiable
Job Title: Director of Quality
Pharmaceutical Vaccine Manufacturing
Location: Berlin, Germany
Are you passionate about ensuring the highest quality standards in pharmaceutical manufacturing? Are you ready to make a significant impact on public health by leading the quality assurance efforts for vaccine production? Join our dynamic team as the Director of Quality and contribute to the global fight against diseases. We are a reputable pharmaceutical company dedicated to developing and manufacturing lifesaving vaccines, and we are looking for an experienced and visionary professional to oversee our quality operations in Berlin.
Responsibilities:
Develop and implement a comprehensive quality management system for vaccine manufacturing, ensuring compliance with regulatory requirements (e.g., GMP, GLP, GCP).
Establish and maintain quality control standards and procedures to ensure product safety, efficacy, and consistency.
Lead a team of quality professionals, providing guidance, mentoring, and support to drive a culture of excellence and continuous improvement.
Collaborate with crossfunctional teams, including R&D, production, regulatory affairs, and supply chain, to develop and implement quality strategies and initiatives.
Conduct regular audits and inspections to identify and address potential quality issues, and drive corrective and preventive actions.
Oversee the qualification and validation of manufacturing processes, equipment, and facilities, ensuring compliance with industry standards.
Manage relationships with regulatory authorities and participate in regulatory inspections and audits.
Monitor industry trends and regulatory changes, and proactively implement necessary updates to quality systems and processes.
Drive the implementation of quality metrics and KPIs to monitor and improve the performance of quality systems and processes.
Requirements:
Bachelor's degree in Pharmacy, Chemistry, Biology, or a related field. Advanced degree (MSc, PhD) preferred.
Minimum of 10 years of experience in quality assurance or quality control within the pharmaceutical industry, with a focus on vaccine manufacturing.
Indepth knowledge of regulatory requirements (e.g., EMA, FDA) and guidelines governing pharmaceutical manufacturing (GMP, GLP, GCP).
Proven track record of successfully leading quality teams and implementing quality management systems in a pharmaceutical manufacturing environment.
Strong understanding of vaccine manufacturing processes, including formulation, aseptic processing, and fillfinish operations.
Experience with regulatory inspections and audits, with a solid understanding of the inspection process.
Excellent leadership and people management skills, with the ability to inspire and motivate a diverse team.
Strong analytical and problemsolving skills, with a keen eye for detail.
Excellent communication and interpersonal skills, with the ability to collaborate effectively with crossfunctional teams.
Fluency in English; knowledge of German is a plus.
Consultant:
Lauren Flynn