Novartis invites Manager/Sr. Manager QA Third Party Operations, APAC

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: Manager/Sr. Manager QA Third Party Operations, APAC

Job Description
Job Purpose
The QA Manager/Sr. Manager of Third Party Operations provides leadership in the management of QA & Compliance requirements at third party contractor sites for IntOps in Asia & Pacific (APAC). The incumbent will:
- Ensure that all aspects of the pharmaceutical operations at third party contractor sites in comply with the requirements of the Novartis Corporate Quality Manual and meet all relevant cGMP regulatory and regulatory requirements.
- Ensure evaluation is performed at each sites and that Novartis has a general understanding of the level of cGMP compliance for products manufactured, packaged, tested and released at third party contractor sites through defined key performance and quality performance indicators.
- Ensure performance of risk evaluation and implementation of quality action plans at sites to address the risks identified.
- Collaborate with the local OU QA units in the market to improve, harmonise and establish QA and Compliance systems strengthen quality awareness, and support third party contract operations.
- Provide technical services and support to the local OU QA unit as part of the new site selection process, as well as troubleshooting of quality issues at existing sites. Lead quality investigations using applicable process improvement and problem solving techniques to assure successful outcomes of Novartis and external Health Authority inspections in all third party contractor sites.
- Ensure that product weaknesses and risks associated with third party sites are known and communicated to the organization so that they can be proactively escalated and mitigated.

Major Accountabilities
* QA oversight to assigned third party contractor sites
• Ensure implementation of Novartis quality standards and GMP requirements at third party sites to ensure that all aspects of the pharmaceutical products at third party contractor sites comply with the requirements of the Novartis Corporate Quality Manual.
• Ensure that Quality Assurance Agreements are established, approved and remain current with third party sites.
• Ensure the local market QA Unit is informed as appropriate of any deviations, change controls, audit findings, or complaints which may have impact on product sold in their market.
• Ensure that all deviations associated with third party sites are properly investigated, documented, evaluated, and closed in accordance with the approved procedure
• Ensure that change controls associated with third party sites are properly performed, documented, evaluated, executed and closed as per procedure.
• Ensure complaint records are adequately monitored and escalated to investigation reports when required, closed in a timely manner, and trending is performed for third party sites.
• In the event of critical quality concerns, ensure that the formal escalation process is followed in collaboration with the local OU QA Units and in accordance with the Novartis Quality Manual.
• Ensure stability data is available and appropriately reviewed for products from third party contractors.

* Risks Management and Risks Control
• Ensure that periodic Contractor Quality Risk Assessments (CQRA) are performed collaboratively with a cross functional team in accordance with OTC global procedure.
• Ensure tracking, timely and appropriate closure of effective corrective / preventive actions at third party sites.
• Ensure that product weaknesses and risks associated with third party sites are known and communicated to the organization so that they can be proactively escalated and mitigated.
• Ensure that any commitments made to address Novartis audit observations or Health Authorities inspection findings at third party sites are implemented as described in the agreed time frame.
• Assist the audit team in audit preparation and provide support during the audit execution of commercial third party sites.
• Provide leadership directives and support on significant quality issues and complex troubleshooting needs of the markets.

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* Continuous Improvement
• Utilize active thinking to generate creative solutions to complex technical problems.
• Participate as required in regular business review meetings and ensure quality topics, KPI’s, and concerns are raised and discussed with Novartis and third party site management.
• Work with the global QA organization as a liaison between Novartis and third party sites for any corporate or global initiatives regarding quality and compliance.
• In the event of a product recall assessment, ensure that a timely evaluation is performed with cross functional team as described per procedure.
• Ensure APR / PQR is available and reviewed in acceptable time period for all products from third party sites and appropriate actions are identified and tracked
• Provide support to the site selection process and new TPO sourcing strategy. Provide QA leadership as part of the due diligence procedure for the assessment of new business opportunities.

Candidate Profile:
Education :
* Masters Degree in Chemistry, Pharmacy, Biology, or related Science or discipline.
Language:
* Fluent English required with excellent communication and negotiation skills (oral and written). Business working knowledge of another language is a plus.
Experience
* 10-15 year’s relevant leadership experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control, R&D and/or Drug Regulatory Affairs.
* Experience of the manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements. Experience of managing QA at Third Party Manufacturing operations a must.
* Shows insight and good judgement in assessing complex or uncertain alternatives, including the risks of each. Considers impact of decisions on other part of the organization before making them and proposing a solution.
* Proven evidence of Systematic Problem Solving Skills including mastery of tools & skills required to handle QA remediation initiatives (FMEA, brainstorming, Fishbone, Root Cause Analysis or equivalent)
* Expert knowledge of Quality Systems with strong technical understanding and hands on experience of the pharmaceutical production (facilities, utilities, equipment, production processes, validation and laboratory controls).
* Champions Novartis Values; especially quality and customer focus, leadership, flexibility to re-organise own use of time to face emergencies in the organisation.
* Excellent knowledge of computer systems (i.e. Microsoft Word, Excel, PowerPoint, & Visio) with demonstrated skills in the use of information management systems in a GxP environment (Trackwise, LIMS, SAP).
* Experience in working in an international and multidisciplinary environment.
* Willingness to travel internationally; sometimes at short notice
Travel time: 20-30 %.

Additional Information:
Job ID: 102771BR
Experience: 10-15
Location: Thane
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: Production
End Date: 25^th June, 2013