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)
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.
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
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