Jun 22, 2022

Job Description

26000+! That’s how many employees at Sandoz worldwide. We are a division of the Novartis Group and a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to high-quality and affordable medicine worldwide. Join us and pioneer access for more patients!

Your responsibilities include, but are not limited to:

• Ensure that all aspects of the handling, manufacturing and distribution of pharmaceutical products in the country comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP regulatory and legislative requirements. Report on a monthly basis to the business and function, on QA activities in accordance with global KPI’s.
Ensure that a local Quality System and Standard Operating Procedures are in place for all GMP/GDP related activities and that compliance with cGMP/GDP regulations is maintained through training and internal audits.

• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the country. Ensure that co-ordinated contact is maintained with the Regulatory Authorities (TGA, Medsafe), the local partners (suppliers, third parties, licensees, and distributors) and Global Quality Assurance.

• Establish a good working relationship with the Supply Chain Management (SCM) and Regulatory Affairs (RA) departments. Audit, supervise and co-ordinate third party activities and ensure that third party manufacture, (re-)packaging, (re-)labelling, storage and/or distribution of Novartis products is in compliance with Novartis Standards. Ensure appropriate Quality Agreements and Product Specific Annexes (PSA’s) are in place as required.

• Ensure that all drug products are released to the market in accordance with the registered specifications and with local/international regulations. Ensure that an effective Change Control process is in place. Represent the country on Escalation teleconferences, as required. Ensure local issues are Escalated according to Novartis requirements. Ensure country organization readiness for all GMP regulatory inspections.

• Manage external inspections, complaints, recalls, counterfeits and product tampering according to the Novartis Corporate Quality Manual and local written procedures and in compliance with local regulatory requirements. Support / participate in NEM cases as required. Lead External Suppliers Qualification process, acts as Single Point of Contact / SPOC for all quality related activities at the External Supplier. Responsible for driving / initiating External Supplier Quality Risk assessments to be carried out for all External Suppliers. Gaps are Quality Systems to be identified with an evaluation of the associated risks. Remediation plans are to be defined and execu-tion is to be monitored to ensure that issues are suitably addressed

• Ensure conduct of adequate training at the country organization for all GMP and GDP related activities by defining, planning and supporting training activities.
Ensure that all aspects of the handling, manufacturing and distribution of biophar-maceutical / pharmaceutical products are in compliance with the Novartis Pharma Quality Manual, the effective Quality Agreement that they meet relevant cGMP regu-latory requirements and are conducted according to local SOPs.
Ensure that a valid QA agreement defined in line with the requirements of the Global template is in place which clearly defines cGMP roles and responsibilities between Novartis and the External Supplier, as well as Product details and requirements. And implement QA agreement accordingly.

• Responsible for coordinating and ensuring that Quality auditing of External suppliers is carried out according to the Novartis Quality Manual - maintain an annual auditing program, participate in audits, manage action plans and follow up on agreed upon CAPAs. Ensure site readiness for regulatory inspections at External suppliers where appropriate. Responsible for assessing quality trends and driving continuous improvement for processes and product quality performance.

• Escalate any issues or instances of instability per the Novartis escalation policy, and initiate any market action that is required. Support / participate in Novartis Emer-gency Management cases as required. Ensure that Change requests, either from the External Supplier or from Novartis, are managed according to the Quality Agreement and Novartis SOPs from receipt, through to the implementation and closure.
Stability reports and PQR’s, Ensure that the External Supplier provides the required product review or the data as specified in the relevant Quality Agreement on an an-nual basis. Critically assess the performance of the product and process and provide the assessment to the report annually.Ensure that the QA Lead and the Supplier Relationship Manager is kept informed of all critical and major issues which may have an adverse affect on the quality of the product at an External Supplier.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• Education (minimum/desirable): Degree in Life Sciences or related fields
• Languages: English fluent in speaking and writing.
• Experience: Min. 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, quality control, registration, production or a directly related area. Demonstrated leadership experience.

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Group network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.
Novartis Technical Operations
Full Time
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Quality Assurance Manager

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