Senior QA Manager ESO Biosimilars, LM

Job Description Summary

The position ensures all aspects of manufacturing, testing, release and distribution for key bio- logics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.

Job Description

Position Purpose:

The position ensures all aspects of manufacturing, testing, release and distribution for key bio- logics and/or sterile pharmaceutical products at strategic external supplier sites comply with international standards of current Good Manufacturing Practice (cGMP), regulatory requirements, the Sandoz Quality Manual, and the applicable Quality Agreements.

Your Key Responsibilities:

Your responsibilities include, but not limited to:

• Acts according to Sandoz values and behaviours.

• 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’ll bring to the role:

Essential Requirements:

• Bachelor or higher in Biochemistry, Chemistry, Microbiology or an- other related science.
• 10 to 15 years of experience in in the pharmaceutical industry. Min 5 years of experience in the manufacturing of sterile pharmaceuticals. Expert knowledge in aseptic/sterile pharmaceutical pro- cesses 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.

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 access to good healthcare.

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. 

Skills Desired

Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Gmp Procedures, People Management, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence