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- Aufgaben: Lead quality oversight for product distribution across multiple markets and ensure compliance with regulations.
- Arbeitgeber: Join Incyte, a leader in the biotech industry focused on innovative therapies.
- Mitarbeitervorteile: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Warum dieser Job: Be at the forefront of product launches and make a real impact on patient care.
- Gewünschte Qualifikationen: 8+ years in pharma/biotech with strong knowledge of cGMP and GDP; excellent communication skills required.
- Andere Informationen: Travel up to 15% and contribute to a culture of integrity and ethics.
Das voraussichtliche Gehalt liegt zwischen 72000 - 100000 € pro Jahr.
The Manager Commercial QA Packaging & Distribution is responsible for the Quality oversight of product distribution activities in multiple markets. He ultimately ensures that commercial products are distributed to end-customers in compliance with Incyte Quality standards and applicable regulations and GxP guidelines.
He / She oversees the Incyte distribution network in the assigned region. He / She is the QA lead for product launches and establishment of new distribution suppliers in the assigned region.
DUTIES AND RESPONSIBILITIES
- Manage the Incyte Distribution network in line with regional scope.
- Represent QA for country launches and oversee related Change Controls.
- Collaborate with Incyte commercial partners for submissions management.
- Coordinate submissions preparations activities with Incyte QA manufacturing and Incyte CMOs.
- Collect and maintain product submission data as well as country specific GMP accreditations for Incyte entities and partners.
- Represent the QA function for the selection, approval and qualification of new suppliers in line with scope.
- Maintain Quality Agreements up to date in line with the expansion plans.
- Represent QA in Quality Business Reviews with key 3PLs / Distributors / Partners.
- Chair Management Review Board for major and critical product distribution issues.
- Be the QA lead for investigation for deviations within regional scope.
- Perform batch disposition for finished products and coordinate with QP / RP for final release.
- Record, assess and reconcile Product Quality Complaints.
- Develop and provide on the job training on Batch Disposition, Deviation, Complaints and Change Control to new hires as per scope of expertise.
- Perform audits as Lead Auditor according to Incyte audit program.
- Perform all responsibilities in accordance with company policies, procedures, applicable regulations and safety requirements.
- Continuously strive for process improvement in line with Quality Mission.
- Stay current with the applicable International Regulations and promote Quality across the Incyte organization.
- Contribute positively to a strong culture of business integrity and ethics.
- Act within compliance and legal requirements as well as within company guidelines.
REQUIREMENTS
- Academic degree in natural or applied sciences preferred.
- Firsthand experience of min 8 years in the pharmaceutical and / or biotech industry preferably in Quality related roles and in market readiness activities.
- Thorough knowledge in cGMP and GDP and global regulatory requirements.
- Qualified auditor with proven experience in GMP / GDP audits is a plus.
- Strong interpersonal skills.
- Excellent verbal and written communication skills.
- English fluency written and spoken (the company language).
- Travel up to 15%.
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Manager Global Distribution QA Arbeitgeber: Incyte
Kontaktperson:
Incyte HR Team
StudySmarter Bewerbungstipps 🤫
So bekommst du den Job: Manager Global Distribution QA
✨Tip Number 1
Make sure to familiarize yourself with Incyte's Quality standards and applicable regulations. Understanding these guidelines will not only help you in interviews but also demonstrate your commitment to quality assurance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotech industries, especially those who have experience in Quality Assurance roles. Engaging with them can provide insights into the company culture and expectations, which can be invaluable during the application process.
✨Tip Number 3
Stay updated on the latest trends and changes in cGMP and GDP regulations. This knowledge will not only prepare you for potential interview questions but also show that you are proactive and dedicated to maintaining high-quality standards.
✨Tip Number 4
Prepare to discuss your experience with audits and supplier qualifications in detail. Highlight specific examples where you successfully managed these processes, as this will showcase your expertise and readiness for the role.
Diese Fähigkeiten machen dich zur top Bewerber*in für die Stelle: Manager Global Distribution QA
Tipps für deine Bewerbung 🫡
Understand the Role: Make sure to thoroughly read the job description for the Manager Global Distribution QA position. Understand the key responsibilities and requirements, especially regarding quality oversight and compliance with regulations.
Highlight Relevant Experience: In your application, emphasize your experience in the pharmaceutical or biotech industry, particularly in Quality roles. Mention specific examples of how you've managed distribution networks or handled product launches.
Showcase Your Skills: Demonstrate your strong interpersonal and communication skills in your cover letter. Provide examples of how you've effectively collaborated with partners or led teams in previous roles.
Tailor Your Documents: Customize your CV and cover letter to reflect the specific qualifications mentioned in the job description, such as knowledge of cGMP and GDP, and your auditing experience. This will show that you are a perfect fit for the role.
Wie du dich auf ein Vorstellungsgespräch bei Incyte vorbereitest
✨Showcase Your Quality Assurance Expertise
Make sure to highlight your extensive experience in Quality Assurance, especially in the pharmaceutical or biotech industry. Be prepared to discuss specific examples of how you've ensured compliance with cGMP and GDP regulations in previous roles.
✨Demonstrate Strong Interpersonal Skills
Since this role requires collaboration with various stakeholders, emphasize your interpersonal skills. Share instances where you successfully worked with cross-functional teams or managed relationships with external partners.
✨Prepare for Regulatory Questions
Expect questions related to global regulatory requirements and quality standards. Brush up on the latest international regulations and be ready to discuss how you stay current with these changes and implement them in your work.
✨Discuss Process Improvement Initiatives
Be ready to talk about any process improvement initiatives you've led or contributed to in your past roles. Highlight your commitment to continuous improvement and how it aligns with the company's Quality Mission.
