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Supplier Quality
il y a 2 semaines
At J&J Innovative Medicine, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working diligently to make that future a reality for patients everywhere.
Supplier Quality strives to build good relationships with our suppliers, both existing and new.
We rely on our suppliers to provide the materials and services that Janssen need to manufacture to serve our customers around the world.
Our Approach to Supplier Quality is based on Our Credo and our purpose is to earn the trust of our patients and customers by creating a successful supply base to reliably enable the delivery of high-quality products and services.
As a supplier quality Analyst within External Quality, you will ensure quality and compliance for suppliers in adhering to policies, enterprise standards and regulatory guidelines.
Key Responsibilities:
- Manage quality oversight in the selection, qualification, and ongoing monitoring of external suppliers
- Establish and perform periodic review of Quality Agreements
- Ensure robust relationships with internal and external partners to meet supply requirements
- Drive quality engagements with suppliers to identify and implement improvements regarding their reliability and quality culture
- Support the identification and resolution of supplier quality issues and complaints
- Evaluate the impact of supplier change management
- Document risk assessments of a supplier's quality systems by means of support of onsite/remote audits, questionnaires, or other tools to assure the quality and conformity of supplier materials/services
- Monitor quality performance through key performance indicators; analyze data to identify risks and drive implementation of mitigation plans
- Provide support to J&J Innovative Medicines local Site during Customer and HA inspections
Qualifications:
Qualifications:
Education:
Master's degree (or equivalent by experience) is required. A degree focused on Master Drug development is preferred
Experience and Skills:
Required:
- [A minimum of one (1) year or relevant experience in pharmaceutical or related area
- Knowledge and experience with cGMP regulations and ICH guidance.
- Good communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization
Preferred:
- Experience using risk management strategies and tools
- Experience with change control, investigation & complaint handling, corrective actions, and quality agreements
- Work with suppliers in which results are achieved through building productive relationships
- Exposure to regulatory authority inspections
- External auditing experience
Other:
- This role may require up to 10% of domestic & international travel
- Proficient in English and Dutch language (preferred)
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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