Sr Specialist EQ SQ DDS EMEA

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at

Job Function
Quality

Job Sub Function
Supplier Quality

Job Category
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Latina, Italy, Schaffhausen, Switzerland

Job Description
Supplier Quality Drug Delivery Systems (EQ SQ DDS) is a division Johnson & Johnson Innovative Medicines (JJIM) Supply Chain. JJIM Supply Chain is engaged in the manufacturing, global distribution and marketing of Pharmaceutical and Combination Products with markets spanning across Europe, Middle East and Africa, Canada, USA, Asia, Pacific and Latin America.

External Quality (EQ) is a Global Quality organizational unit of JJIM Supply Chain which provides leadership and owns Quality and Compliance oversight on suppliers and external manufacturers who supply materials for JJIM drug products. With a global mindset, and owning expertise across all materials, with strong, compliant and adaptable working processes that are globally harmonized, EQ is an asset and Q&C centre of excellence to the JJIM Supply Chain in regard to selecting the right external partners and securing the external supply chain.

For our EQ Organization, we are looking for a Sr. Specialist EQ – Supplier Quality (SQ) Drug Delivery Systems - EMEA.

Focus Of This Function
This function ensures that the quality standards are achieved and maintained at assigned DDS suppliers through management, and oversight on Quality Operations functions for external business partners. This oversight includes ensuring continuous compliance with relevant regulatory health authority requirements, effective risk management, strategy development and execution, and effective collaboration between R&D, Operations, Procurement, Device Quality, TechOps, Regulatory Affairs and other technical disciplines (EHS).

Functions and activities include quality assurance review, Change Control review, Deviation Handling, Complaint Handling, Coordination of audit activities, Pro-active Quality Engagement, Management of risk mitigation activities, Follow-up of improvement activities for assigned DDS suppliers in EMEA region.

Ensures that business, quality and compliance goals adhere to J&J policies, enterprise standards and government-issued environmental, health, safety, quality and regulatory policies and guidelines.

Represents the JNJ credo and quality values in contact with the suppliers and will comply with the JNJ regulations for ethic and business conduct to strengthen the reputation of J&J.

This position requires the ability of building collaboration and teamwork across the local and global JJIM organization, and it interfaces with the JJIM stakeholders (Global Procurement, Local Quality, Technical departments, Device Quality, …)

Your Responsibilities
Planning, execution, and documentation of the qualification and monitoring of DDS suppliers who are delivering packaging materials, devices and device components to the JJIM Supply Chain for the manufacture of the JJIM Drug Products.

Surveillance on the quality and compliance status for all assigned DDS suppliers, DDS materials, devices and device components.

This QA function captures into all EMEA based JJIM Supply Chain sites.

The Task Profile Comprises But Is Not Limited To

• Initial assessment and qualification of suppliers for product introductions
• Involvement in change management, deviations, complaint management, escalations, compliance issues, recalls, quality related actions that are linked to the assigned DDS suppliers
• Establishment and periodic review of Quality Agreements and Quality Requirements
• Coordination of audits and pro-active Engagements at DDS suppliers
• Establishment and revision of Qualification Statements, periodic performance metrics, and qualification classification for suppliers
• Building collaboration and teamwork across the local and global JJIM Supply Chain organization, and interfacing with internal JJIM stakeholders
• Acting as EQ Supplier Quality representative and subject matter expert during regular audits and health authority inspections
• Acting as Subject Matter Expert concerning EU MDR, Regulated Substances, Combination Products and Device regulations.

Your Profile

• The EQ SQ DDS department is looking for a flexible and analytical person who is taking initiatives and is willing to adopt changes positively, find constructive solutions, and can represent JJIM Supply Chain towards the DDS suppliers.

• Organizational and communicative skills are essential, as well as teaming with external parties to identify and ensure that J&J best practices are implemented in a correct way.

• Professional experience and skills are needed as follows:

• Bachelor's degree and minimal 1-year relevant experience in a quality function

• Minimum 1-year of relevant experience in health authority regulated industry is required (Pharmaceuticals, Medical Devices, OTC/Consumer, etc.)
• Familiar with GMP regulations
• Knowledge of Medical Device, EU MDR and Combination Products regulation is required
• Ability to work in a global environment
• Fluent in English language
• Knowledge of IT applications, e.g., MS Office -Comet -TruVault

The EQ SQ DDS department is offering a multifaceted position with flexibility in terms of responsibilities within a dynamic, international environment and travel of about 10% (international).

Required Skills
Preferred Skills:
Coaching, Communication, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Data Compilation, Econometric Models, ISO 9001, Issue Escalation, Performance Measurement, Problem Solving, Quality Control (QC), Quality Standards, Standard Operating Procedure (SOP), Technologically Savvy, Vendor Selection