Full-Time VP Global Quality – Clinton, NJ
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
- 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 ApplyIkaria 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
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