Senior Specialist EQ - Supplier Quality

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 https://www.jnj.com

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Sr. Specialist EQ - Supplier Quality

The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.

Essential Job Duties and Responsibilities

This role ensures 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.

The responsibilities are within the EQ-SQ organization, that is the JSC quality unit responsible for Q&C oversight of suppliers in the Global Pharma sector, and acts as quality partner for all API and DP IM SC manufacturing sites.

This position requires knowledge of all categories used at the corresponding IM site.

• Account Owner (30 - 40% of time):

EQ-SQ member having the Quality oversight responsibility of the assigned Supplier, part of IM Portfolio.

Quality and Compliance lead ensuring quality standards are achieved and maintained at suppliers through management, and oversight on Quality Operations functions for external business partners.

This position will primarily manage Low Criticality Suppliers (e.g. Limited Oversight) as:

• Surveillance on the quality and compliance status for all suppliers under the Account Ownership
• Activity support for the assigned suppliers on any related activities (e.g. impacted change control management / deviation / escalation / complaint handling / Specification alignment / Quality Agreement updating etc.).
• QA Specialist - Support role (60 - 70% of time):

Provides support to the SQ operations, namely to the SQ Schaffhausen SPOC, in the fulfillment of the scope of the respective job, such as, but not limited to: Non-conformances, Supplier Investigations, Change control, Data management, Documentation, audit/inspection support and various QMS related processes required to fulfil the EQ Account owner and SPOC functions.

• Project Management (5 - 10% of time):
• This position may Lead Low/Medium Impact Projects typically from EQ (that could be linked to the annual company and division goals) or from Local IM sites
• Lead and/or participate in strategic and optimization initiatives to improve EQ-SQ management processes

Minimum Qualification

• Minimally basic degree in Pharmacy, Science, Engineering and Technical subjects.
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent computer proficiency e.g. MS Office
• Excellent analytical skills to identify gaps and root causes of issues and think out of the box to develop a solution.
• Must be able to work independently with minimal supervision to meet tight deadlines and maintain a positive attitude.
• A minimum of 4 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with proven experience in managing external manufacturing operations or Quality Assurance for external manufacturing.
• Frequently collaborates with internal operating companies and R&D partners on a wide variety of product, process, project and compliance related issues.
• Interfaces with internal IM functional groups to broker the necessary technical support for external partners. Interactions are required with MSAT, DPDS, Procurement, EHS, Planning, the different IM manufacturing sites, but also with the other quality groups within J&J and on enterprise level, such as Compliance, Quality unit API manufacturing, Quality systems and the different Qualified persons.
• Familiar with GMP – and International Conference on Harmonization (ICH) – regulations.
• Exposure to regulatory authorities’ inspections.

Other requirements

The position requires the ability of building collaboration and teamwork across the local and global J&J organization, and it interfaces IM External Quality with the quality unit of suppliers.