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Job Details

Quality Program Manager - Compliance - Pharmaceutical

Company: Elevate Direct Ltd
Location: High Wycombe
Reference: PH-AL-QPMJJ-150217
Closing Date: 01 Mar 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Quality Program Manager / High Wycombe / 10 Months Contract / Up To £57 Per Hour

Requirements:

Quality Program Manager / High Wycombe / 10 Months Contract / Up To £57 Per Hour

 

Responsible for daily monitoring (Mining) of external industry regulatory intelligence information for GxP and business sector applicability, as well as, internal inspection outcomes and trends. This includes coordination of internal searches to identify applicability within business functions. Provide results to respective Quality and Compliance organizations to facilitate any assessment of potential impact.

Lead and support commenting opportunities associated with draft regulations/guidances relevant to GxP business support areas. Work closely with BRQC and business functions, as well as, applicable Regulatory Affairs and external outreach functions (e.g. GRPI, ERO) to enable and solicit commenting. Responsible for compiling comments and providing an aligned position to contribute further in the commenting process.

Responsibility for identification (Monitoring) of new or revised regulatory requirements with the potential to impact relevant to GxP scope of BRQC and respective business areas. This will includes tracking of monitoring activities as well as completion of an initial high level impact assessment communicated to potentially impacted functions.

Responsible for supporting the formal council having oversight responsibilities for regulatory standards management (e.g. Adopting Regulatory Requirements Council). This includes coordination of agenda topics, meeting minutes and generation of metrics.

Responsible for the development of metrics and material content for presentation of Regulatory Intelligence topics. This includes key external trends and HA inspection outcomes for presentation at various forums and management meetings for the purpose of ensuring awareness of current status and sharing of information.

Responsible for maintaining the regulatory intelligence infrastructure current including tools and modes of communication to ensure the timely access and sharing of information

Responsible for developing, enhancing and maintaining libraries of regulatory intelligence information to enable individuals within both BRQC and business functions to access relevant information.

BRQC Regulatory Intelligence responsibilities

Experience with GxP compliance topics. Must have a working knowledge of worldwide GCP, GLP, PV, and IT compliance regulations and guidelines. Must be capable and resourceful in the use and navigation of current and emerging technology and tools to further the Regulatory Intelligence program. Must be capable of navigating and analyzing high volumes of information. Must have excellent written and verbal communication and presentation skills. Ability to manage organizational tasks and meeting materials.

Non Technical Skills and Additional Details

Experience with GxP compliance topics. Must have a working knowledge of worldwide GCP, GLP, PV, and IT compliance regulations and guidelines. Must be capable and resourceful in the use and navigation of current and emerging technology and tools to further the Regulatory Intelligence program. Must be capable of navigating and analyzing high volumes of information. Must have excellent written and verbal communication and presentation skills. Ability to manage organizational tasks and meeting materials

The Company

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

 

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

 

Apply for this job: Quality Program Manager -  Compliance - Pharmaceutical

Contact Information:

Address:  Head Office
138 Southwark St, London 
SE1 0SW
England
Tel:  0207 928 2519
Website:  Visit Our Web Site

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