A
global healthcare leader, Novartis has one of the most exciting product
pipelines in the industry today. A pipeline of innovative medicines
brought to life by diverse, talented and performance driven people. All
of which makes them one of the most rewarding employers in their field.
Post: DRA QA Senior Manager
Job Description:
Globally responsible for oversight of Regulatory Compliance within DRA and across functions defined by critical control points for processes and procedures. Perform self-assessments in DRA and process interfaces and thereby ensuring identification and resolution of compliance gaps and issues on an on-going basis. Support DRA for internal audits and Health Authority inspections. Support implementation of effective and efficient processes that fulfill regulatory requirements and expectations in a sustainable way for the global Novartis portfolio of products.
Give input to and support the global DRA QA Compliance strategy
• Responsible for a robust compliance monitoring system to ensure DRA regulatory compliance on an on-going basis; provides adequate tracking and oversight to any regulatory inspection commitments and ensures their timely closure.
• Support DRA and provide guidance to create relevant remedial and improvement actions for CAPA plans from audit findings, and responsible for follow-up of audit CAPAs to ensure timely closure.
• Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory compliance risks
• Performs self-assessments in DRA; ensures review and approval of proposed CAPA activities for their effectiveness and timely closure
• Oversee that regulatory processes and procedures at the in global DRA meet regulatory and company expectations and are part of the on-going monitoring processes
• Support a compliance and quality culture within DRA through effective cross-functional team work and open communication
• Ensures timely investigation and tracking of DRA HQ relevant deviations and incidents in collaboration with DRA PIE. Ensures review and approval of proposed CAPA activities, and their timely closure.
• Provides expert advice and input to DRA CPO deviations, incidents, audit and inspection findings, as required.
• Escalate, as needed, compliance gaps to CPO QA and CPO DRA for local deviation handling and resolution
• Support implementation of new regulatory requirements by analyzing their impact on the company’s on-going compliance
• Escalate compliance status and potential compliance risks, as necessary, to DRA QA Management
• Work effectively within the DRA QA and Dev. QA, and build a strong working relationship with DRA and other relevant line functions (e.g. CPO QA)
Globally responsible for oversight of Regulatory Compliance within DRA and across functions defined by critical control points for processes and procedures. Perform self-assessments in DRA and process interfaces and thereby ensuring identification and resolution of compliance gaps and issues on an on-going basis. Support DRA for internal audits and Health Authority inspections. Support implementation of effective and efficient processes that fulfill regulatory requirements and expectations in a sustainable way for the global Novartis portfolio of products.
Give input to and support the global DRA QA Compliance strategy
• Responsible for a robust compliance monitoring system to ensure DRA regulatory compliance on an on-going basis; provides adequate tracking and oversight to any regulatory inspection commitments and ensures their timely closure.
• Support DRA and provide guidance to create relevant remedial and improvement actions for CAPA plans from audit findings, and responsible for follow-up of audit CAPAs to ensure timely closure.
• Support regulatory risk management through identification, assessment, mitigation and communication of any potential regulatory compliance risks
• Performs self-assessments in DRA; ensures review and approval of proposed CAPA activities for their effectiveness and timely closure
• Oversee that regulatory processes and procedures at the in global DRA meet regulatory and company expectations and are part of the on-going monitoring processes
• Support a compliance and quality culture within DRA through effective cross-functional team work and open communication
• Ensures timely investigation and tracking of DRA HQ relevant deviations and incidents in collaboration with DRA PIE. Ensures review and approval of proposed CAPA activities, and their timely closure.
• Provides expert advice and input to DRA CPO deviations, incidents, audit and inspection findings, as required.
• Escalate, as needed, compliance gaps to CPO QA and CPO DRA for local deviation handling and resolution
• Support implementation of new regulatory requirements by analyzing their impact on the company’s on-going compliance
• Escalate compliance status and potential compliance risks, as necessary, to DRA QA Management
• Work effectively within the DRA QA and Dev. QA, and build a strong working relationship with DRA and other relevant line functions (e.g. CPO QA)
Candidate Profile
Education: Scientific Degree in Life Sciences
Fluency in English, written and spoken. German is desirable
At least 10+ years professional experience in Regulatory in the Pharmaceutical and/or Medical Device Industry
Very good understanding of GXP Regulations and global Regulatory Guidelines
• Strong interpersonal and communication, negotiation and problem solving skills
• Good knowledge of the regulatory processes for drug de-velopment and regulatory compliance of marketed products.
• Ability to work globally to initiate and co-ordinate the work of associates at all levels
• Ability to communicate concepts and ideas verbally and in writing
• Excellent negotiation and interpersonal skills
• Ability to work effectively cross-functionally, in a team environment across cultures
• Considerable organization awareness (e.g. interrelation-ship of departments, business priorities) including experi-ence working cross-functionally and in global teams.
Education: Scientific Degree in Life Sciences
Fluency in English, written and spoken. German is desirable
At least 10+ years professional experience in Regulatory in the Pharmaceutical and/or Medical Device Industry
Very good understanding of GXP Regulations and global Regulatory Guidelines
• Strong interpersonal and communication, negotiation and problem solving skills
• Good knowledge of the regulatory processes for drug de-velopment and regulatory compliance of marketed products.
• Ability to work globally to initiate and co-ordinate the work of associates at all levels
• Ability to communicate concepts and ideas verbally and in writing
• Excellent negotiation and interpersonal skills
• Ability to work effectively cross-functionally, in a team environment across cultures
• Considerable organization awareness (e.g. interrelation-ship of departments, business priorities) including experi-ence working cross-functionally and in global teams.
Additional Information:
Job ID: 166649BR
Experience: 10+ Year
Qualification: Scientific Degree in Life Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
Location: Hyderabad
End Date: 30th June, 2015
Job ID: 166649BR
Experience: 10+ Year
Qualification: Scientific Degree in Life Sciences
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
Location: Hyderabad
End Date: 30th June, 2015
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