Senior QA Manager

Job Description Summary

Responsible for managing quality aspects at external suppliers to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Sandoz Quality Manual and is conducted according to the relevant Standard Operating Procedures.

Job Description

Are you passionate about ensuring high-quality standards in pharmaceutical products? Do you thrive in a dynamic, interdisciplinary, and international environment? If so, we invite you to join us at Sandoz, now operating with a renewed strategic focus, increased agility, and a strengthened culture.

Your responsibilities will include:

• Provides direction and formulates strategies to maintain and improve external supplier quality oversight. Establishes and maintains quality relationship with suppliers.
• Acts as Single Point of Contact / SPOC for all quality related activities at assigned external suppliers. Provides the quality presence and input to technical meetings with the external suppliers and establishes good working relationships. External supplier quality related activities are further described in the subsequent paragraphs. Conducts all necessary trainings in due course to be suitably qualified to perform the assigned duties.
• Supplier qualification: Ensures a valid Quality Agreement in line with the requirements of the Sandoz global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks. Ensures site readiness for regulatory inspections and quality audits and supports during such events.
• Routine monitoring: Assesses quality trends and drives continuous improvement including stability reports and annual product quality reviews. Critically assesses the performance of the product and process performed at the external supplier. Escalate any issues or instances of instability as necessary.
• Incident management: Manages all quality issues (complaints, deviations, OOX). Ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. Escalates and represents cases within the Sandoz quality escalation process and initiate any market action that is required.
• Change controls: Ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure.
• Manufacturing process and analytical methods transfers: Ensures QA Oversight during commercial product transfers. Assesses validation readiness. Ensures knowledge transfer for stable commercial manufacturing operations. Supports the establishment of continuous process verification programs.
• Ensures all aspects of Quality Management of the assigned project are carried out according to the standards defined. Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs follow-up on resulting measures.
• Ensures that management is kept informed about all critical and major issues which may have an adverse effect on the quality of the product produced at the assigned external suppliers.

What you need to bring to the role:

• Bachelor or higher in Biochemistry, Chemistry, Microbiology or an- other related science
• Fluent English mandatory
• Min 8 years of experience in in the pharmaceutical industry.
• Min 5 years of experience in manufacturing of sterile pharmaceuticals.
• Expert knowledge in biosimilar pharmaceutical processes and manufacturing of biologics.
• Min 5 years of experience in operational quality assurance.
• Expert knowledge of cGMP requirements for major regulated markets (EU, US). Advanced experience with FDA, EMEA and other Health Authorities.
• Expert in risk management.
• Advanced understanding of project management.
• Expert in communication and advanced negations skills.
• Advanced decision-making skills.
• Basic leadership skills.

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 (y)ours to shape!

Commitment to Diversity & Inclusion:

Sandoz is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Pioneering access for patients

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, visit Sandoz.com/careers

#ProudtobeSandoz

Skills Desired

Audit Management, Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management, People Management and Leadership, Product Release, Qa (Quality Assurance), Self-Awareness, Technological Expertise