Job Description Summary
Build, lead and supervise the Quality Unit in Osterweddingen. Provide quality assurance oversight and be accountable for supporting quality operations and provide technical and strategic leadership for all quality-related matters. Accountable to ensure compliance to cGxP standards, US FDA 21CFR210/11, EMEA, AMG and AMWHV, Sandoz rules and applicable market regulatory requirements. Guide on critical quality decisions, ensuring support and oversight with regards to budget, headcounts, people and organizational development.Job Description
Your Key Responsibilities:
Your responsibilities include, but not limited to:
- Provide leadership, direction and support to the site Quality Unit
- Provide leadership for strategic site initiatives, and represent site SLT quality in local cross-functional teams representing site quality
- Assure site inspection readiness and lead Health Authority inspections, e.g. US FDA, EMEA
- Ensure overall compliance to cGMP during manufacturing, testing and distribution of drug products meeting Sandoz and Health Authority requirements, ensuring product quality, safety, and availability of products
- Implementation of local quality systems that comply with Sandoz standards, local and international regulations. Ensure effectiveness of quality systems
- Drive for Site management team accountability. Coordinate the generation and monitor the execution of the Site Quality Plan, DI Plan, Site Quality Risk Assessment and other relevant gap assessments
- Drive a culture of continuous improvement and quality excellence, fostering cross-functional collaboration and talent development
- Ensure proper preparation and consolidation of the budget for the Quality Unit
- Ensure adequate management of product critical quality issues. Ensure investigations are correctly executed and adequate CAPAs are defined, and proper follow up of CAPAs effectiveness.
- Ensure timely notification, management escalation and reporting of potential quality issues / defects.
- Responsibility for the strategic planning, organization and control of work processes in the quality unit
- Define, implement, monitor, consolidate and analyse Site Quality KPIs. Ensure Site Quality Committee is established, ensure relevant corrective and preventive actions are endorsed and implemented.
- Responsibility for occupational safety, health and environmental protection in the area
What you’ll bring to the role:
- Education in natural sciences or equivalent
- 10+ years of professional experience in the pharmaceutical industry in Quality or Manufacturing (e.g. Site Head, Production Head or Site Quality Head roles)
- Proven track record and practical experience in operating in full compliance with global cGMP requirements. Successfully managed inspections from major Health Authorities (US FDA, EMEA)
- In-depth knowledge of cGMP, FDA regulations (21 CFR Parts 210, 211), local regulations and ICH regulations
- Proven ability to manage risk and lead with strategic foresight
You’ll receive:
Sandoz has an employee-first approach and that’s why your personal growth is so important to us. You will have access to Coursera and other learning platforms with more than 200,000 learning videos and 5000+ courses.
In addition to the various learning opportunities, we offer company benefits, such as:
30 days of annual leave
Holiday allowance
Additional rewards for special occasions (e.g. service length awards, marriage celebration, etc.)
Company pension schemes and capital formation benefits
Parental leave
Other offerings, such as bike leasing
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.
Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.
The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.
#Sandoz
Skills Desired
Agility, Agility, Audit Management, Business Acumen, Business Partnering, Business Strategy, Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Finance Acumen, Health Authorities, Knowledge Of Gmp, Leadership, Manufacturing Production, Organizational Savvy, People Management, Problem Solving Skill, Product Release, Qa (Quality Assurance), Quality Control, Quality Management, Quality Management Systems (QMS), Root Cause Analysis (RCA), Self-Awareness, Six Sigma {+ 4 more}Top Skills
What We Do
Sandoz is the global leader in generic and biosimilar medicines.
Our Purpose is to pioneer access to medicines for patients globally. We are on a mission to drive innovation in the healthcare industry by freeing up resources sustainably and responsibly while continuing to address global health challenges such as antimicrobial resistance.
We are present in more than 100 countries and our medicines serve some 500 million people every year. We have two main global businesses: Generics - divided between standard generics and complex generics - and Biosimilars.
