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Quality Assurance Lead - Turkey-MEA

Locatie

Turkije

Functie/Business Area

Quality

Afdeling

Quality Assurance

Werkcategorie

Arbeidsovereenkomst voor onbepaalde tijd

Functiebeschrijving

Quality Assurance Lead - Turkey-MEA

About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division. Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

The Opportunity:
As Quality Assurance Lead Turkey-MEA (T-MEA), you will be responsible for providing independent oversight of the implementation and administration of a comprehensive Pharmaceutical Quality System for the area covering Turkey, Middle East and Africa, to maintain a state of GMP compliance.
In this role, you will act as the Responsible Manager in Turkey and have legal responsibility for product release and Quality Assurance activities in Turkey.
In this position, you will report into the Head, Quality Assurance Latin America & MEA and have two direct reports within the Area. You will support the inspection activities by the Turkish and Regulatory authorities at T-MEA and at foreign manufacturing sites including assisting with communications during the inspections and responding to questions and observations from the Regulatory authority as necessary.

Hybrid working:
At Astellas we recognise that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

Key Activities:
Establish, implement, and maintain the Quality Management systems for deviation management, complaint handling, change control, supplier management, annual product review, and quality agreements for T-MEA. Ensure applicable Global and Regional Policies and Procedures are incorporated into local procedures.
Provide oversight for Quality activities for Distribution Business Partner companies for distribution of Astellas products in over 20 countries in the MEA territory. Ensure timely release of product and facilitate the resolution of all deviations, non-conformances and other batch related issues.
Prepare for, host, and respond to GDP/GMP Inspections by Competent Authorities and QA Internal audits. Collaborates with Astellas Pharma International BV Responsible Person to ensure alignment of Quality Management Systems of the MEA territory and of AP-INT.
Ensure all local suppliers, Distribution Business Partners, and third parties providing GMP/GDP activities are audited and observations reported in line with Astellas procedures.
Manage contract manufacturing activities (including re-packaging or re-labeling operations) to ensure they are performed according to GMP standards.
Promote a Culture of Quality across T-MEA functions to establish a quality mindset.

Essential Knowledge & Experience:
Profound work experience in a similar role within quality assurance in a global pharmaceutical organization in the region.
Manufacturing site experience in Quality Assurance or Quality Control is required for the role of Responsible Manager
Strong communication & collaboration, working cross-functionally within matrix structures
Strong written and verbal communication in English.

Preferred Knowledge & Experience:
Prior experience in the role of Regulatory Manager in Turkey
Prior people management experience
GMP/GDP Auditing Experience
Experience working with distribution partners across the Middle East region

Educations/Qualifications:
Degree issued by a school of pharmacy, medicine, or one of the branches of chemistry, or equivalent.

Additional information:
This is a permanent, full timefull-time position.
The position is based at the T-MEA regional headquarters of Astellas Pharma in Istanbul.
This position follows our hybrid working model. Role is blend requires a blend of hime andof work from home and a minimum of 3 days per month in our Istanbul office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

What We Offer:
A challenging and diversified job in an international setting.
Opportunity and support for continuous development.
Inspiring work climate.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.