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13 Apr 2012

Full-Time VP Global Quality – Clinton, NJ

Jewish Jobs Clinton Township, New Jersey, United States

Job Description

The VP, Global Quality has responsibility for developing, implementing, and communicating Ikaria’s global quality strategy, people, and systems, including quality control, quality assurance, quality systems, and total quality management. Quality will have oversight over all operating units including pharmaceutical R&D, medical device design and development, and drug/device manufacturing organizations. The top quality executive will be responsible for promoting the company’s quality programs internally and externally including customers and regulatory authorities. The individual must translate Ikaria’s quality strategy into tactical policies, processes and procedures that are properly resourced, well communicated, and effectively executed to meet global regulatory, medical/health and legislative standards.

The position will have global responsibility, with a strong current emphasis on the US, which is where the company’s marketed drug and delivery systems are developed and manufactured. Additionally, the company has a number of products in development and has an aggressive business development licensing and acquisition program, and this executive will be responsible for QA/QC on all products pre- and post market approval. Finally, the position will oversee the company’s marketed products in Mexico, Australia, Canada, and Japan.

The successful executive will be a trusted partner to business leaders, will understand organizational objectives, and will build and lead a team of quality experts appropriately resourced to provide the skills, expertise and support required to meet organization objectives.

REPORT AND RESPONSIBILITIES

This position reports directly to the Senior Vice President, Legal and Corporate Development. The executive will have responsibility for ensuring that:

  • All systems and processes within Ikaria’s commercial      manufacturing and distribution functions operate in accordance with the      established Codes of Good Practice (Good Laboratory Practice, Good      Manufacturing Practice, and Good Clinical Practice);
  • Operations are appropriate for the development,      manufacture, testing and release, and distribution of product meeting all      quality and regulatory standards;
  • Ikaria is appropriately represented in matters related      to compliance and quality, especially in communications with the health      authorities, including the Food and Drug Administration, the European      Medicines Evaluation Agency, Health Canada, TGA, Cofepris, and MHLW;
  • Global strategies are harmonized through collaborative      relationships to ensure that appropriate changes are identified and      implemented, such that quality concepts are consistently disseminated      throughout the worldwide manufacturing facilities as well as external      constituents;
  • Continuous improvement in all aspects of total quality      management are developed through a well-educated and adequately resourced      workforce;
  • Local management at all manufacturing sites are      adequately resourced and operating in compliance with cGMPs and adhering      to the principles of worldwide guidelines such as ICH;
  • Continuous improvement opportunities are identified and      implemented across products, processes and service worldwide;
  • Collaborative relationships are developed and fostered      within all levels of the organization as well as within external      constituents through coordinated systems of training and employee      development;
  • A centralized and consistent corporate approach to      quality is implemented and effective at both the corporate office,      manufacturing sites and where appropriate external vendors.

In collaboration with pharmacovigilance, the head of Quality has the responsibility for matters related to:

  • Product and process disposition in the United States,      Europe, Japan, Mexico, Canada, Austtalia, and other regions of the world      where product is put into the market;
  • Recall of products or services from the market; and
  • Appointment of individuals to the quality functions at      headquarters or any of the manufacturing facilities.

Reporting to this position are:

  • Director Quality, Drug & Biologics
  • Director Quality, Medical Devices
  • Director Quality, Compliance & Auditing
  • Director, Quality Systems
  • Director Quality, Clinical

Requirements

REQUIREMENTS

  • Advanced degree in chemistry, engineering or a related      scientific, pharmaceutical science or equivalent field
  • A minimum of 8 years experience as the responsible      person for pharmaceutical quality management and leadership in an      international FDA-regulated business
  • Experience with both drugs and medical devices
  • Expert knowledge of cGMPs, including hands-on knowledge      of their interpretation and application, and quality issues related to GCP      and GLP
  • Experience in technical writing at levels of scientific      procedure and

reporting, CMC sections of registration dossiers

  • Established experience in dealing with high-level      regulatory authorities such as the FDA and other international regulatory      authorities
  • The position also requires a highly motivated      individual with exceptional strategic thinking and visionary attitudes      that will promote and cultivate the support of all others within the      company to achieve and maintain the required levels and standards of      quality, compliance and ethical conduct

How to Apply

Ikaria is an equal opportunity employer. Applicants receive consideration for employment without regard to race, color, religion, sex, age, national origin, disability, veteran status, pregnancy, sexual orientation, gender identity, or membership in any other class protected by applicable federal, state, local or foreign anti-discrimination laws. Type Full-time Location Corporate http://www.candidatecare.com/srccsh/job.guid?_reqID=2000013035310

Job Categories: Other. Job Types: Full-Time.

Endless.

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