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Senior Manager, Qualified Person & Quality Assurance Responsible, Turkey

BiogenIstanbul, tr

30+ gün önce

İş tanımı

Company Description

Job Description

We are seeking a highly skilled and motivated Qualified Person (QP) to oversee the importation, release, storage, and distribution of Biogen products in Türkiye. This role is pivotal in ensuring our products meet the highest standards of quality and compliance with national and international regulations.

Key Responsibilities :

QP Finished Product Lot Certification :

Serve as the Qualified Person (QP) in line with Turkish regulations.
Independently certify imported products for the Turkish market, ensuring they meet all GMP and regulatory requirements.
Oversee the compliance of Biogen products with national and international regulations, as well as internal policies.
Manage authorized activities and ensure meticulous record-keeping.
Review and approve Product Quality Reviews (PQR / APR).

Licenses and Compliance Maintenance :

Stay informed about GMP / GDP and evolving regulatory requirements, ensuring licenses and distribution models are current and compliant.

Lead and coordinate GMP and GDP Health Authority Inspections and internal audits.

Oversee risk management and self-inspection programs to maintain high standards.

Quality Assurance Operational Activities :

Ensure Biogen Türkiye operates under a compliant Quality Management System (QMS), aligned with global standards.

Develop, implement, and maintain local procedures in accordance with both local regulations and Biogen’s global QMS.

Lead local implementation of QMS, prepare and host Quality Management Reviews (QMR), and oversee customer qualification.

Manage investigations, CAPAs, change controls, and continuous GMP / GDP training programs.

Approve subcontracted activities and develop local Quality Agreements.

Product-Related Market Issues :

Coordinate local recall activities and manage product returns.

Oversee technical product complaints and market activities, ensuring effective communication with Health Authorities.

Address suspected falsified products and manage temperature excursions.

Ensure customer complaints are resolved effectively and promptly.

Qualifications

Bachelor’s degree in Pharmacy, Medicine, or Chemical Sciences (minimum 4 years).

Certification as a Qualified Person according to Turkish regulations.

Minimum of ten years’ experience in manufacturing, quality assurance, or quality control within the pharmaceutical or biotech industry.

Demonstrated expertise in GMP / GDP compliance and quality oversight.

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. to learn more about our DE&I efforts.