HireDiversity

Horsham, PA, US

Manager, External Supply Integration (ESI) Quality Americas-1574120615

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 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. 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 QA technical support for External Manufacturers in the Americas. This individual will assist in the development of corrective action plans and monitor implementation. This individual assists in the development, writing and implementation of quality procedures. The Manager, ESI Quality Americas will provide QA support for technology transfer 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. This individual will conduct investigations, perform customary audits, collect data, analyze trends, and prepare reports as required. The Manager, ESI, Americas assesses current quality systems and recommends improvements in order to enhance quality and reduce cycle time. This individual monitors trends, identify issues, recommend and implement appropriate actions. This individual will provide cGMP compliance support to contract manufacturers by investigating and resolving quality issues. The Manager, ESI Quality Americas will coordinate and provide concurrences on deviations. This individual will travel to External Manufacturer's sites to provide cGMP assistance and quality oversight. This individual participates and leads audits of External Manufacturers. The Manager, ESI Quality Americas assists with regulatory inspections and provides follow up on regulatory commitments. This individual will develop, implement, and review of SOPs for interactions with External Manufacturers. This individual will investigate customer product quality complaints and apply cGMP regulations and other FDA and international requirements to all aspects of the position. The Manager, ESI Quality Americas will coordinate change control documentation and approval process. This individual will provide Quality oversight and participate on technology transfer teams. This individual will also interface with other functions (Operations, Planning, Technical Operations, etc) in the support of External Supply Integration.

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., EMEA ICH Q8, 9, 10) is preferred. Demonstrated understanding of highly regulated manufacturing processes and associated GMP compliance requirements is required. Experience managing projects is 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 candidate may be required to travel up to 20%, domestically and internationally, with the potential for higher periods based on the business needs and will be based in Horsham, PA or Raritan, NJ.

If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today!

Primary Location:North America-United States-Pennsylvania-Horsham
Other Locations:North America-United States-New Jersey-Raritan
Organization: JANSSEN SUPPLY GROUP, LLC (6046)
Job Function: Quality (Generalist)