Assocaite Director, Qualified Person
Location: Germany
Job Description:
We are seeking a highly qualified and experienced Associate Director to join our team. The ideal candidate will be a Qualified Person (QP) with a strong background in vaccines and holding a 15.3 qualification. This role is critical in ensuring the quality and compliance of our vaccine products, and the successful candidate will play a key role in our leadership team.
Key Responsibilities:
Oversee the quality assurance processes for vaccine production, ensuring compliance with regulatory standards and guidelines.
Act as the Qualified Person (QP) for the release of vaccine batches, ensuring all products meet the required quality standards.
Develop and implement quality management systems and processes to ensure continuous improvement in vaccine production.
Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure the successful development and commercialization of vaccine products.
Provide expert guidance on vaccine-related quality issues and regulatory requirements.
Lead and mentor a team of quality professionals, fostering a culture of quality and compliance.
Stay updated on the latest developments in vaccine technology and regulatory requirements, ensuring the company remains at the forefront of the industry.
Conduct internal audits and inspections to ensure compliance with GMP (Good Manufacturing Practice) and other relevant standards.
Represent the company in interactions with regulatory authorities and other external stakeholders.
Key Qualifications & Skills:
Degree in life sciences, pharmacy, or a related field.
Qualified Person (QP) certification with a 15.3 qualification.
Extensive experience in the pharmaceutical industry, with a strong focus on vaccines.
In-depth knowledge of GMP, regulatory requirements, and quality assurance processes.
Proven track record of successfully managing quality assurance in vaccine production.
Excellent leadership and team management skills.
Strong analytical and problem-solving abilities.
Exceptional communication and interpersonal skills.
Ability to work effectively in a fast-paced, dynamic environment.
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