Opening for Master’s in Sciences / Pharmacy as Senior Manager QA, GCO in Novartis

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: Senior Manager QA, GCO

Job Description
To provide Quality Assurance support for the Global Clinical groups, Franchises/Oncology and clinical-related Line Functions; ensures that the systems and processes are fit for their intended purpose and meet all applicable Novartis internal and external regulatory standards; ensure quality and compliance guidance for the development and implementation of correc-tive and preventive actions & ensure adequate regulatory inspection and audits preparation
- Support the implementation of a quality culture within the clinical groups/ organization by es-tablishing operational quality governance and oversight. Guide the teams in quality and com-pliance decision making to drive sustainable quality and compliance excellence
- Provide interpretation of GCP regulations and company standards, guidelines, policies and procedures to personnel/ clinical development teams. - Support the implementation of applicable Quality Standards through the implementation of global processes, appropriate SOPs and procedures. Ensure that regulatory controls are in place in relevant process steps for clinical operations on global and local level. Provide quality oversight for planned changes in processes and procedures, as applicable.
- Support the implementation of the annual Quality Plans; identify relevant areas to be ad-dressed in future Quality Plans. Support appropriate management review of all quality and compliance related topics including the review of key quality indicators.
- Provide quality oversight for deviations and ensure that adequate corrective and preventive actions (CAPA’s) are implemented. Provide leadership and guidance during the development and execution of corrective and preventive actions (CAPA). Coordinate and review CAPAs to audits to ensure adequate root cause analysis and systemic solutions
- Support and ensure implementation of adequate training within assigned clinical groups for all GXP and Pharmacovigilance activities by defining, planning and supporting training activities. Monitor adherence to training schedules and training completion rates. Escalate any training related issues.
- Support proper Quality oversight is implemented within clinical groups for 3rd parties / ven-dors / outsourced activities.
- Ensure a continuous state of Health Authority inspection readiness for assigned clinical groups and their activities by facilitating regulatory inspection preparation, management and follow-up in the global function. Support local inspections with adequate systems and process support. Represent QA in interactions with internal and external contacts and Health Authorities, as appropriate. Ensure proper communication with relevant groups & line functions throughout inspection preparation, management and follow-up.
- Identify ways to continuously improve quality and compliance with regulations and company standards, policies and procedures through partnership with personnel, Development Line Functions and Development QA groups
- Closely cooperate with the Development QA Quality Systems Excellence, Auditing and Com-pliance and Operations Excellence groups; participate and provide Quality and Compliance input for process improvement teams to ensure consistency of quality and compliance activi-ties and effective communication.
- Support the Regional Clinical Operations Heads and their teams with Quality input and over-sight for the execution of clinical trials under their responsibility.
- Aligns regional and general Development QA priorities with the local Head of Development QA. For matters related to general local / regional Development QA this position will report to the local Head of Development QA with close collaboration of global clinical QA management.

Candidate Profile
• Master’s in Sciences / Pharmacy/ Medicine or equivalent
• Very good written and spoken English.
• 8-10 years of involvement in clinical trial or related regulated activities; broad understanding of global expectations of Health Authorities in the GCP/PV/GXP regulated areas.
• Specific understanding or experience of the Clinical trial management and monitoring would be an added advantage
• 5 or more years people management experience incl. experience in a matrix environment (desirable)
• Strong management, interpersonal, communication, negotiation and problem solving skills
• Project management skills (desirable)
• Considerable organization awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global environments

Additional Information:
Experience: 8-10 Years
Education: M.Pharm, M.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 140620BR
End Date: 30^th June, 2014