Johnson & Johnson Careers

Source Quality&Compliance - External Manufacturing Q&C Lead

Pomezia (Santa Palomba), Italy

Job Description

Requisition ID: 1805635680W

Caring for the world, one person at a time... inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.

Johnson & Johnson Consumer Europe is a leading supplier of Fast Moving Consumer Goods. Our products are produced and distributed in all major European countries and exported overseas. The J&J Consumer Europe Center of Excellence is at the heart of a growing global business with world class manufacturing standards, producing leading brands. J&J has an open culture with strong principles that have been incorporated in our company credo. This is an opportunity for you to become involved in a challenge operational set-up and deliver on stretch targets. State of the art technology supports the product portfolio and goes along with many opportunities to further develop your skill set

For the Quality Assurance EMEA department, we are looking for a

Q&C Lead, External Manufacturing (Ref: 0000)

Provides Q&C leadership in the management, deployment and implementation of Q&C initiatives to assigned contract manufacturing sites (EM) engaged in the production of J&J products.

Other tasks include:

External manufacturers (EM):
• To manage the assigned EM(s) portfolio against the acceptable GMP and applicable ISO Standards (i.e: 9001; 13485) and assure high product quality
• To drive the strategy for the assigned EM portfolio in view of the business needs
• To carry out GMP/for cause audits and follow-up audit action plan proposal and progress; provide technical support
• To assure continuous improvement process of the External Manufacturers through KPI and Management Action Plan
• To manage quality issues: review of deviations, out of specifications, and other critical issues; lead investigations, follow up on resulting CAPA`s and action plans
• To collect change control related information from EMs and to evaluate proposed changes together with R&D, Regulatory, External Operations and procurement
• To assess validation protocols and reports
• To review complaints, support of complaint investigation, follow up of EMs action plan resulting from complaint investigations
• To lead and follow-up on the implementation of the different QA projects/new WWSP (Worldwide Standard Procedures) at the assigned EM sites
• Support evaluation of new EMs and be QA responsible for the qualification of new EMs

EMEA Regional Program:
• To take part in Enterprise Regulatory & Compliance initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM(s) sites
• To take part in the implementation of the different QA projects / new J&J standards at a regional and global level
• Participate and potentially lead initiatives for cost and efficiency improvements within the organization

Support to EMs Business & External Growth:
• QA support in Business Continuity Plans / Reformulation / Cost Improvement Projects
• Support Supplier Reliability Initiatives as agreed with line manager

• A minimum of a Bachelor's Degree is required in Engineering, Pharmacy, Chemistry, Life Science, or related disciplines.
• 5-6 years experience in an Q&C or QA environment with experience in the pharmaceutical, cosmetic or food industry
• In-depth knowledge of the industries associated regulations (EU GMPs, FDA, ISO or Food)
• Ability to adapt to a changing environment and strong analytical and problem-solving skills
• Customer oriented and pro-active attitude
• A hands-on mentality, demonstrating autonomy and showing the ability to balance expectations and requirements of different stakeholders, prioritizing work and meeting strict deadlines
• Self-starter: takes initiative, creates a result orientated environment
• Ability to work in a matrix organization
• Strong project management competence and process oriented mindset (process excellence)
• Fluency in English is required; Fluency in additional European languages is a plus
• IT literacy, E2E process orientation

If you are a creative and innovative mind passionate about one or more of our industries and want to become part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.)

Primary Location
Italy-Lazio-Pomezia (Santa Palomba)
Johnson & Johnson S.p.A. (7170)
Job Function
Requisition ID