External Quality Manager
il y a 6 jours
Janssen Supply Group, LLC, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager, External Quality (Small Molecules) located Europe or North America.
In this position you will provide end to end quality oversight for external manufacturers and strategic partners, ensuring consistent delivery of pharmaceutical products that meet or exceed safety, regulatory compliance, and product standards.
**Key Responsibilities**:
- Provide quality leadership and technical support to ensure effective execution of quality systems at external manufacturing sites
- Manage quality oversight in the selection, qualification, and ongoing monitoring of external partners
- Support the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
- Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, specifications, validation documentation, and technical studies.
- Monitor quality performance through the development of key performance indicators; analyze data to identify risks and drive implementation of mitigation plans.
- Build relationships with internal and external partners to meet patient supply requirements.
- Support external manufacturers to continuously improve processes and procedures focused on reliability, execution, and quality culture.
- Collaborate with external manufacturers to support health authority inspections; monitor and follow-up on associated response and commitments.
- Provide oversight for tech transfer and new product introduction activities.
- Support risk management initiatives necessary to improve performance.
**Qualifications**:
**Education**:
- A minimum of a Bachelor's or equivalent University degree is required with a focus in life science, engineering, physical science preferred.
**Experience and Skills**:
**Required**:
- A minimum of 5 years working in a GMP regulated environment.
- Experience with quality support of clinical and commercial manufacturing operations.
- Experience managing quality oversight for pharmaceutical production.
- Ability to work independently in support of a portfolio of products and suppliers.
- Ability to quickly process complex information and make critical decisions with limited information.
- Experience working on cross-functional project teams.
- Strong communication, influencing and leadership skills, demonstrating an ability to communicate at all levels of the organization.
**Preferred**:
- Experience working with external partners.
- Experience with product transfer, new product introduction, parenterals, and/or combination products.
**Other**:
- This role may require up to 25% of domestic & international travel.
- At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. _
- Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. 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. _
-
Senior Manager, Product Quality Management, Quality
il y a 7 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator**! The position can be based at one of the following sites: Wayne, PA; Titusville, NJ; Raritan, NJ; Horsham, PA; or Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen,...
-
Quality Manager Car-t
il y a 1 semaine
Beerse, Belgique Brunel Temps plein**Brunel is an international company with a long and successful history in project sourcing. We owe our unique reputation to our strength and stability, but above all to our consultants. They make the difference. Their motivation, passion and energy form the basis of our success formula.** **Would you also like to be part of our team?** *** **For our...
-
Senior Manager, Product Quality Management
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator**! The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Raritan, NJ; Horsham, PA or...
-
Manager Product Quality Owner
il y a 4 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Manager Product Quality Owner. The position should be based on the following sites: Raritan, NJ, Beerse, Belgium, Latina, Italy, Leiden, The Netherlands, Cork, Ireland, Malvern, Springhouse, Chesterbrook, USA, Schaffhausen in Switzerland, Guaynabo, Puerto...
-
Sr Manager Product Quality Integrator
il y a 3 jours
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a **Senior** **Manager, Product Quality Management, Quality Integrator**. The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA or Chesterbrook, PA At...
-
Senior Manager, Product Quality Integrator
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinJanssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Manager, Product Quality Integrator, Launch & Grow Biotherapeutics. The position can be based at one of the following sites: Cork, Ireland; Leiden, Netherlands; Beerse, Belgium; Schaffhausen, Switzerland; Titusville, NJ; Horsham, PA; or Chesterbrook,...
-
Manager, R&d It, Bioresearch Quality
il y a 1 semaine
Beerse, Belgique Johnson & Johnson Family of Companies Temps pleinJanssen is recruiting for a Manager, R&D IT, BioResearch Quality & Compliance (BRQC) located in Raritan, NJ; or Beerse, BE. This position may require up to 20% travel (domestic and international). At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways...
-
Sr Anlst Quality Assurance
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAt 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...
-
Jsc Quality New Modalities Quality Head
il y a 5 jours
Beerse, Belgique Johnson & Johnson Temps pleinPosition Title: Janssen Supply Chain Quality New Modalities Quality Head Supervisor Title: Vice President, Janssen Supply Chain Quality Department Name: Janssen Supply Chain Quality Physical Location of Role: Raritan, NJ, but other locations in PA and NJ, US and Beerse, Belgium may be considered. **Position Summary** The Janssen Supply Chain Quality New...
-
Lead (Non-managerial) Technology Quality Systems
il y a 2 semaines
Beerse, Belgique Johnson & Johnson Temps pleinThe Lead of Systems & Infrastructure Assurance - Research & Development/Clinical, is responsible for building and execution of quality into enterprise wide systems, tools, services and infrastructure through the end-to-end lifecycle (design, develop, implement, maintain, retire). This is a non-managerial function without direct reports. **Responsible...
-
Manager QA Ops Eyecare/tds/pellets Jsc Beerse
il y a 3 semaines
Beerse, Belgique Johnson & Johnson Temps pleinWe are looking for an employee that has a passion for quality and loves to operate in a very dynamic pharmaceutical production environment. We are looking for an employee that likes to work with people, has the ability to connect easily with our different business partners and is gets a lot of energy developing our young talent. At the JSC Beerse site,...
-
Quality Engineer
il y a 3 semaines
Beerse, Flandre, Belgique Arcadis Temps pleinResponsible for integrating quality standards to mitigate failure mode risks during risk-based assessments in asset management design reviews.Ensure compliance of qualification activities.Review and approve qualification documents.Review and approve calibration and maintenance records.Review and approve certification master data.Responsible for reviewing and...
-
Quality Engineer
il y a 3 semaines
Beerse, Flandre, Belgique Arcadis Temps pleinQuality Engineer Role: Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviews Ensure compliance of qualification activities. Review and approval of qualification documents. Review and approval of calibration and maintenance records Review and approval of...
-
Quality Engineer
il y a 2 semaines
Beerse, Flandre, Belgique Arcadis Temps pleinQuality Engineer Role: Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviewsEnsure compliance of qualification activities.Review and approval of qualification documents.Review and approval of calibration and maintenance recordsReview and approval of certification master...
-
Quality & Process Manager
il y a 5 jours
Beerse, Belgique SARPI Temps pleinDescription de l'entreprise En qualité de pionnier dans le traitement et la valorisation des déchets dangereux, Veolia a ouvert la voie il y a plus de quarante ans en créant **SARPI** afin de répondre aux défis technologiques, économiques et environnementaux de ses clients et partenaires. Aujourd’hui, SARPI est le principal acteur en Europe dans le...
-
Quality & Performance Manager
il y a 5 jours
Beerse, Belgique SARPI Temps pleinBedrijfsomschrijving Als pionier in de verwerking en terugwinning van gevaarlijk afval heeft Veolia meer dan 40 jaar geleden de weg gebaand door **SARPI** op te richten om de technologische, economische en milieu-uitdagingen van haar klanten en partners aan te gaan. Vandaag de dag is SARPI de belangrijkste speler in Europa voor de verwerking en terugwinning...
-
Grant Expert Manager – EU Funding
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAt 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...
-
Sr Manager Project Management
il y a 2 semaines
Beerse, Flandre, Belgique Johnson & Johnson Temps pleinAt 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...
-
Site Lead, Pes New Product Introduction
il y a 7 jours
Beerse, Belgique Johnson & Johnson Family of Companies Temps plein**"Caring for the worldone 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...
-
Manager Product Owner Udi
il y a 4 jours
Beerse, Belgique Johnson & Johnson Temps pleinJohnson & Johnson Service, Inc. is current recruiting for a Manager, Product Owner - Unique Device Identifier to be located on-site or near a Johnson & Johnson Services, Inc. site in the United States, Brazil, Belgium, or Ireland! Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. We...