QA ManagerNovartis

Job Description
#1! Sandoz was the first pharmaceutical company to receive approval of a biosimilar in Europe, Japan and the United States. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
The QA Manager will be responsible for effective management ensure all quality-relevant processes within (Philippines) Country Organization are compliant and that non-compliance is appropriately ad-dressed via corrective and preventive actions (CAPA) and/or escalation of issues.
Key Responsibilities
Provide Quality oversight and governance to ensure proactive compliance with Internal and Health Authority GxP requirements, and to meet business expectations. Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, prod-uct approval delays, or which would negatively impact the financial performance of the com-pany, as well as the company's reputation.
Ensure that all aspects of the handling, manufacturing, and distribution of pharmaceutical products in the country comply with the requirements of the Company Quality Manual and meet all relevant cGMP regulatory and legislative requirements.
Supervise and coordinate third party activities and ensure that third party repackaging, rela-beling, storage and/or distribution of the products are in compliance with Company Standards.
Support the implementation of local Quality Systems and Standard Operating Procedures for all GMP/ GDP related activities and that compliance with cGMP/ GDP regulations is maintained through training and self-inspection.
Provide GxP QA support (e.g., local SOP administration, deviation handling, and training com-pliance) to The Philippines clinical operations team.
Ensure effective quality governance and quality planning in the Country Organization through the implementation of the annual Quality Plan, the Country Quality Review Board, appropriate Key Quality Indicators, and Quality Risk Assessments.
Ensure management of complaints, recalls, counterfeits and product tampering according to the Company Quality Manual and local written procedures.
Support the lead coordinator and regional Business Information Security Expert in organiza-tion roll-out of information security and risk management initiatives (mainly on awareness) as well as support in organizational requirements related to records management
Minimum requirements
Bachelor's Degree or equivalent 4-Year University degree in a Scientific or Technology field (e.g., Chemistry, Pharmacy or other Life Science). Advanced degree preferred.
More than 8 years of experience in Pharmaceutical Industry across Quality Commercial/Quality Operations/Manufacturing/Development.
Expert understanding of GxP regulations from major Health Authorities
Prior experience in the development and implementation of Quality Management Systems incl. Compliance & Auditing and dealing with Health Authorities.
Prior experience in Regulatory submissions and registration
Prior experience in Product Lifecycle and product portfolio management
Demonstrated ability to build trusting relationships with senior management and other business stakeholders. Demonstrated business acumen and ability to identify stakeholders' needs and adapt communications style.
Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.
Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 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!
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, join the Novartis Network here: https://talentnetwork.novartis.com/network
Functional Area
Quality
Division
SANDOZ
Business Unit
Commercial OPS SIR SZ
Employment Type
Regular
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Shift Work
No
Early Talent
No
Novartis

Metro Manila
Permanent
Full-time