Quality Assurance Manager At Sandoz Egypt
Quality Assurance Project Manager At Sandoz Egypt
Job Description:
We are seeking a highly motivated Quality Assurance Project Manager to join our global team.
1. Lead the development of a Quality Culture with high awareness on data integrity and close collaboration with the Sandoz region business partners and ensure a state of the art Country Quality Organization is in place to best support overall business strategy.
2. Oversee all Good manufacturing/clinical practices processes and ensure their implementation is in alignment with Sandoz Quality Manuals, Global Operational Procedures and health Authority requirements.
3. Establish effective quality oversight and ensure the relevant Quality Plan is implemented in the Sandoz Regional and Country Organizations. Ensure product launches are properly identified, planned, monitored and executed in a QA standpoint, including analytical methods transfers needs, proper allocation & availability of resources during and post-launch
4. Participate and represent the region in escalation meetings, but also ensure quality/regulatory escalations are identified, registered and properly sup-ported/resolved with the purpose to ensure business continuity
5. Establish regular review and assessment of Key Quality Indicators at the Sandoz regional Quality Committee and Executive Committees
6. Facilitate early and fast communications between commercial and QA functions, driving the necessary urgency related to potential stock outs and loss of sales.
7. Provide leadership as required regarding quality interpretation of Regulatory requirements.
8. Keep stakeholders informed about the progress of investigations and trans-late quality issues into an understandable and clear language to the business & other necessary QA functions.
9. Facilitate the transfer of knowledge & QA activities status from the countries to be presented and discussed during regional meetings or other venues
10. Monitor top priority products for any potential issues and act to help mitigate them. Ensure timely and compliant product release in the countries.
11. Support BD&L initiatives and oversee that supplier’s management process’ are properly executed.
12. Liaise with Supply Chain, Sandoz Technical Operation (including External Supply Operation) and other necessary departments (Local / Regional / Global) to ensure appropriate escalation, prioritization and management of business needs and quality related issues, providing leadership and expertise to troubleshoot manufacturing process deviations and analytical testing issues.
13. Promote together with the Regional Quality Head and Country Quality Heads a consistent quality culture & talent management across the region
14. Support or coordinate necessary projects in the region
Minimum requirements
Bachelor’s degree or PhD in Life Sciences, Pharmacy or Medicines.
Demonstrated experience of success leading an organization or project of high impact
Fluency in English (oral and written); knowledge of other languages spoken in the respective region is a plus
8 to12 years of Quality Assurance experience and involvement in regulated activities; broad understanding of global expectations of Health Authorities in Good manufacturing/clinical practices
Knowledge of Quality Systems and Health Authority regulations (Sterile and non-sterile products)
Deep understanding of Change Control System, Complaints, Deviation and Country Product Release, in particular for commercial products. Regulatory Affairs knowledge is also required.
Ability to work independently on complex problems/issues and determine acceptable solutions and approaches.
Demonstrated ability to build trusting relationships with senior management and other business stakeholders.
Excellent communication, negotiation, consulting/facilitation, and interpersonal skills.
Candidate should have Lean Six Sigma certification such as Green Belt, Black Belt etc.