Job Description Summary
Join us as a Founder of our ‘new’ Sandoz!
Job Description
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our ‘new’ Sandoz!
The purpose of the role:
• Build and lead the Sandoz Country Quality Organisation, UK & Ireland and drive the Quality agenda within the Country organisation in line with Global, Regional and Country needs.
• Direct and lead the Country Quality organisation to ensure quality governance and enable development of effective quality values, standards and culture. Ensure compliance to all regulatory standards and that all quality relevant processes are compliant and that non-compliance is appropriately addressed via corrective & preventive actions (CAPA) and/or escalation of issues.
• Provide strategic and proactive QA leadership to drive and implement high performance team for
• quality systems and all commercial product related activities in Sandoz UK &Ireland in close collaboration with local business partners and other key stakeholders.
• Lead the optimisation of quality processes in the Country and effectively collaborate with global internal partners to find successful solutions within the quality framework that consistently fulfil the needs of the patient and external stakeholders.
• Prevent significant quality issues or regulatory non-compliance which could lead to product stock-out or withdrawal, product approval delays or which would negatively impact the financial performance of the business as well as the reputation.
Your Key Responsibilities:
Your responsibilities include, but not limited to:
Build, lead, and retain a team of high-performing quality professionals, mentor and coach individuals on the team to develop and retain quality leaders as well as build a culture of high performance and impact.
Oversee objective setting and performance management process among the direct reports. Perform integrated planning, priority setting, and execution of activities fully synchronized with SCQ and local business partners.
Ensure quality governance and quality planning in the Country organization through the establishment and implementation of the annual Quality Plan, the Country Quality Management Reviews, monitoring of appropriate Key Quality Indicators and Quality Risk Assessments.
Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that support on all quality related matters is provided to the country. Communicate local specific regulatory requirements to Global Quality Assurance to ensure that they are taken into account for global processes, as appropriate.
Ensure Country organization readiness for GMP/GDP audit and inspection. Ensure adequate GMP/GDP inspection/audit preparation, management, and follow-up. Ensure communication with local Health Authorities is adequately shared within the organization and commitments tracked and closed on time.
Ensure a local self-inspection program is established.
Ensure that drug products are released to the market in compliance with the registered specifications, Marketing Authorization and cGMP, and is distributed in compliance with cGDP.
Ensure that deviations/complaints are investigated, decided and follow-up. That corrective / preventive actions are implemented, as appropriated.
Ensure that the management of product incidents, product emergencies and market actions, is taken care of in a timely and effective manner. Participate in the global escalations calls and lead the local committees, when needed, to assess local impacts and/or implement decisions from the Global Escalation team. Liaise with all relevant stakeholders.
Provide quality oversight of local GxP vendors and ensure that they are qualified to perform their activities in compliance with Sandoz Quality Standards.
Lead of quality systems including compliance to global/local procedures and maintenance of local procedures. Liaise with global quality system owner and where appropriate participate in expert networks and influence within global projects/initiatives.
Ensure local efficient GxP training program is established.
Identify and support strategic quality initiatives and improvements. Collaborate with Regional and Global quality colleagues to influence and implement high impacted global projects within country and at Regional / Global level.
Ensure that adequate Quality resources are available through the annual quality plan and budget process for the Country Quality Organization.
Interact with the Country organization to provide direction and support for all quality GMP/GDP matters. Act as a role model for Values and Leadership Behaviours, taking positive action to strengthen quality culture and awareness.
What you’ll bring to the role:
Essential Requirements:
Bachelors or Masters Degree Life sciences
Eligible QP status and experience across both sterile and non-sterile dosage forms
Minimum of 10years’ experience in Quality working in Pharmaceutical/ Biotech/Health Care industries.
Strong management, interpersonal, communication, negotiation and problem solving skills.
Strong project management skills, including simplification mindset, strategic thinking and ability to lead changes.
Ability to interact with Senior Business Leaders on a regular basis to align on the strategic direction.
Industry Network within pharmaceutical associations
Demonstrated knowledge and experience working within the UK Medicines regulations
Proven experience in collaborating with multinational teams
Proven experience in managing Product release across multiple product forms within global supply chain frameworks
Demonstrated experience in hosting health authority inspections and global audits
Demonstrated experience in building quality management systems.
Knowledge of GCP and Pharmacovigilance requirements
Demonstrated experience in building relations with Health authorities and regulatory bodies
Demonstrated experience working as a Responsible Person for Import (RPi)
Experience operating as a Responsible Person on WDA is desirable
You’ll receive:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 24 days annual leave, Flexible working arrangements, Employee recognition scheme, learning and development opportunities.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
Our momentum and entrepreneurial spirit 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, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!
The future is ours to shape!
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.
Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Sandoz Talentpool (novartis.com)
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Skills Desired
Agility, Agility, Business Acumen, Business Partnering, Business Strategy, Collaboration, Communication Skills, Continued Learning, Dealing With Ambiguity'S Awareness, Decision Making Skills, Goal-Oriented, Health Authorities, Leadership, Logical Thinking, Problem Solving Skills, Qa (Quality Assurance), Quality Management, Risk Management, Stakeholder Management, Storytelling, Strategic Planning, Strategic Thinking, Supplier Relationship Management (Srm), Team Management, Teamwork {+ 1 more}