Senior Manager - Quality & Regulatory Compliance - Healthcare

Executive Hiring is looking for a Sr. Mgr. - Quality & Regulatory for a Large MNC Outfit, based at Aurangabad.

A Post Grad in Chemistry, Pharm with at least 10-12 years of work exp. of handling Quality & Regulatory Compliance of a Large Orgn., belonging to the Healthcare Industry, with good amount of knowledge and exp. in performing GxP, GMP audits / support of medical devices.

The Ideal candidate should be experienced in managing all aspects of Quality and Regulatory Compliance in an international, global or regional (Asia Pacific) context, in a regulated healthcare environment.

Knowledge of medical devices regulatory requirements and Experience in the medical devices or pharmaceutical industry is preferred.

KRA's

- Maintaining robust Compliance Program for Medical Device manufacturing sites.

- Internal Audits program management

- Maintaining regulatory inspection readiness plan at each manufacturing site, also supporting manufacturing site regulatory inspections as required

- Overseeing the significant regulatory compliance issues in the manufacturing sites,

- Provide input to the Franchise Compliance lead on the classification of all Regulatory Health Authority inspections and supply chain-related observations at all the manufacturing sites and severity of field actions within the region and to Quality Operations on manufacturing plant-related recall activities as required

- Managing the Site Compliance team

In case this of interest to you, please forward your resume, mentioning CTC.

For any further clarity, pl feel free to reach out to Sanjoy @ + 91 9046968619 at the earliest.

Executive Hiring

Supply Chain Practice