Job Description Summary
Through effective leadership ensure a robust Quality Management System where all quality-relevant processes within the Country Organization are compliant and non-compliance is appropriately addressed via corrective and preventive actions (CAPA).
Provide Quality oversight and governance of all GxP processes to ensure proactive compliance with with all pharmaceutical laws, the Sandoz Quality Manual and Policies, as well as Industry Best Practices.
Prevent quality or regulatory non-compliance issues which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the company, as well as the company reputation.
Job Description
Major accountabilities:
Quality Management System :
- Implementation maintenance and continuous optimization of Quality Management System, Document Management, Training Management, Change Management
Compliance:
- GxP regulation implementation (including monitoring of local HA websites), oversight of GxP activities (e.g. Patient Safety, Regulatory, Medical etc), CAPA Management, APQR review, MAH review activities, Narcotics management and reporting, Superuser and Access Management for QA IT tools
- Obtain/maintain legally required licences
- Management of audits / inspections / self-inspections
- Management of local external suppliers (incl. warehouses / labs)
- Data integrity and e- compliance
- Compliance monitoring: Continuous monitoring of Key Quality Indicators
Management of Risks and issues:
- Exception management (Complaints, Deviations, Quality Events, CAPAs resulting from exceptions), Incident management, Returns management, Risk assessment of unexpected product issues, Communication of unexpected product issues with Health Authorities
Batch release activities
- Ensure continuous compliance of internal processes with Good Manufacturing Practice cGMP and GxP guidelines.
- Ensure that all commercial batches are released for market/ distribution in compliance with Marketing Authorization and on time according to business and patient needs, where appropriate.
- Ensure oversight of our commercial warehouse activities.
Quality Strategy & Planning
- Act as the company key point of contact for Health Authority for pharmaceutical products and thereby provide a link between supplying sites and the agency.
- Annual Country Quality Plan implementation
- Annual Quality Management Review
- Annual Quality Risk Assessment: Creation & implementation of identified of actions
- Ongoing continuous improvement & process simplification
- Operational excellence project initiation / support
- Project management of relevant projects / Launches / BD&L activitie
Business & Team Management
- Lead the development of a Quality Culture with high awareness on Sandoz values and behaviours. Establish a close collaboration with Country business partners and ensure a сompliant Country Quality Organization is in place to best support overall business strategy.
- Attract and develop talent in the organization supporting a diverse and inclusive culture. Ensure robust performance management to optimize productivity across the organization. Provide active mentoring and coaching of associates at all levels. Lead the implementation and execution of the talent management strategy for all key positions.
- Management of Country QA budget.
Key performance indicators:
- Robust and effective QMS implemented - Quality and compliance metrics monitoring system effectively implemented. No Health Authority overdue commitments from inspections.
- Market release / Release for distribution for commercial supplies performed in line with Marketing Authorizations/regulations, where appropriate.
- Implementation tracking of issued Quality Manual modules consistently in place.
- Customer/stakeholder satisfaction and corresponding feedback tracked regularly.
- Performance against Key Quality Indicators.
- Delivery of the Quality Plan, Budget.
- Progress against Quality Risk Assessment.
- Availability of fully qualified key Quality personnel, with succession plans and robust Talent pipeline
What you will bring to the role
- Bachelor’s degree in pharmacy or any related field
- 10+ years of experience in Quality assurance with at least 7+ years in managerial role in a pharmaceutical industry
- Strong experience in Quality Assurance, GMP compliance, Quality Management Systems (QMS) and Audits and inspections
- Proven track record leading QA teams and handling health authorities
- Collaborating across boundaries
- Operations Management and Execution
- People Leadership skills
- Project Management skills
- Excellent command of English and Arabic language
Skills:
- Agility.
- Audit Management.
- Business Acumen.
- Business Partnering.
- Collaboration.
- Communication Skills.
- Continuous Learning.
- Dealing With Ambiguity.
- Decision Making Skills.
- Goal Oriented.
- Guideline.
- Inspection Preparedness.
- Leadership.
- Logical Thinking.
- Problem Solving Skills.
- QA (Quality Assurance).
- Quality Decision Making.
- Quality Management.
- Regulation.
- Self-Awareness.
- Stakeholder Management.
- Teamwork.
- Technological Expertise.
Why Sandoz?
Sandoz is the global leader in Biosimilar and Generic medicines, a segment of the healthcare industry that delivers 80% of the world’s medicines at 30% of the cost, touching the lives of more than 1 billion people across 100+ countries! While we are proud of our achievements, we have an ambition to do more so that everyone can achieve the basic human right of good health.
With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help even more people gain access to low-cost, high-quality medicines, sustainably.
Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills, experience an agile and collegiate environment with impactful careers, where diversity of thought is welcomed and where personal growth is supported!
Join us, help us make healthcare fairer and faster.
Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve
#Sandoz
Skills Desired
Agility, Audit Management, Business Acumen, Business Partnering, Collaboration, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Goal-Oriented, Guideline, Inspection Preparedness, Leadership, Logical Thinking, Problem Solving Skills, Qa (Quality Assurance), Quality Decision Making, Quality Management, Regulation, Self-Awareness, Stakeholder Management, Teamwork, Technological Expertise
