Manager, External Supply Integration (1 of 2)-3873140905
Description
Janssen Supply Group, LLC, a member of Johnson & Johnson's family of companies, is recruiting for a Manager, External Supply Integration (ESI) Quality Americas to be based in Horsham PA and/or Raritan, NJ
Janssen Pharmaceuticals Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including in oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Our products portfolio comprised of pharmaceuticals, biologics and combination products. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency. Janssen Supply Group, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
The Manager, ESI Quality Americas will provide quality leadership and oversights to External Manufacturers in the Americas to ensure product quality, safety and compliance.
This individual will be responsible for the monitoring, identification, and control of risk for External manufacturers used in Janssen Supply Chain. This individual will be responsible for escalation and communication of quality and compliance issues and provide quality recommendations. This individual will implement partner development programs, continual improvements, corrective and preventive plans and monitor implementation. This individual will apply cGMP regulations and other FDA and international requirements to all aspects of the position.
The Manager, ESI Quality Americas will provide QA support for technology transfer, validation and improvement of existing manufacturing processes. This individual will contribute to the overall development, implementation and execution of quality systems in support of the manufacture of pharmaceutical products to ensure cGMP compliance, inspection/PAI readiness and product quality meeting global regulatory expectation.
The Manager, ESI Quality Americas will provide technical support, review, and approval for product/process nonconformances and investigation conducted by external supply partners. This individual will travel to External Manufacturer's sites to provide cGMP assistance and quality oversight. This individual will investigate customer product quality complaints, conduct GMP audits, collect data, analyze trends, and prepare reports as required.
This individual participates and leads audits of External Manufacturers. The Manager, ESI Quality Americas provides support to external partner with regulatory inspections and provides follow up on regulatory commitments.
The Manager, ESI Quality Americas will coordinate change control documentation and approval process. This individual will be responsible for ensuring quality agreements are in place with external partners and are compliance to J&J standards.
This individual will also interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply Integration project team, providing expertise in business/process excellence. The Manager, ESI, Americas assesses current quality systems and recommends improvements in order to enhance key quality and business metrics.
Qualifications
A Bachelors degree is required. A focused degree in Physical/Life Science or equivalent is preferred. An advanced degree is preferred. A minimum of 8 years of experience working in a GMP regulated environment is required. Experience in a Pharmaceutical/Biologics Manufacturing or Quality Environment is required. A minimum of 3 years of experience in a quality role is required. Demonstrated knowledge of applicable regulations within the US (FDA) and outside the US (e.g., EudraLex, EMEA ICH Q8, 9, 10) is preferred. Quality Risk Management experience is required. Knowledge in device regulation, QSR, and/or combo product regulation is highly desirable.
Demonstrated understanding of highly regulated manufacturing processes and associated GMP compliance requirements is required. Experience managing projects is preferred. Knowledgeable in current life cycle approach to validation and understanding of statistics preferred. Certifications in Process Excellence/Six Sigma, Lean Training, Project Management or CQE/CQA are preferred. Experience managing suppliers or external manufacturers is preferred.
Experience in the development, implementation and review of SOPs for interactions with contract manufacturers is preferred. Knowledge of basic principles of Aseptic Processing is preferred. Experience in both the commercial and clinical side of the business is preferred.
Strong big picture orientation with attention to detail is required. The ability to identify leveraging opportunities and solutions is required. Ability to provide guidance, collaborate, negotiate, and effectively work with teams and individuals to ensure processes are developed, understood, provide business value, and are adhered to is required. The ability to engage and align with other diverse and dispersed organizations and functions and negotiate, influence and lead without direct line authority is required. Excellent written and oral communication skills are required. Ability to engage others and lead an organization through continuous improvement and change is required. A strong sense of urgency is also required.
This position can be based in Horsham, PA or Raritan, NJ and may require up to 30% travel, domestic and international, with the potential for higher periods based on the business needs. The ability to work a flexible schedule should business needs arise is also required.
Primary Location:North America-United States-New Jersey-Raritan
Other Locations:North America-United States-Pennsylvania-Horsham
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality Assurance
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