Head Development QA - Drug Delivery Systems

Sandoz•Cambridge, OH

17d

About The Position

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! The Head Development QA Drug Delivery Systems is a permanent member of the SGD Quality Leadership Team and is accountable for the oversight of Quality activities associated with technical development of drug delivery systems including Medical Devices until commercialization. Quality advice will be provided to the Sandoz Device Development Centre, but also to other functions involved in device development. Responsible for setting direction with respective functions to ensure compliant commercialization and maintenance of Drug Delivery Systems including Medical Devices. Collaborating with the Quality System Owner(s) to continuously improve and update the respective Quality Management System.

Requirements

Master’s degree or PhD in Engineering, Pharmaceutical Sciences, Life Sciences, Quality Management, or a related technical discipline.
Formal training in Quality Management Systems (QMS), Medical Device Regulations (e.g., MDR 2017/745), or ISO 13485 highly desirable.
10+ years of experience in Quality Assurance within the pharmaceutical, biotech, or medical device industry, with strong exposure to drug delivery systems and/or medical devices.
5+ years in a senior leadership role, overseeing quality functions in a GxP environment.
Proven experience supporting technical development of combination products or medical devices from concept through commercialization.
Demonstrated expertise in Quality Systems, design control, risk management, and regulatory frameworks relevant to Drug Delivery Systems (e.g., FDA 21 CFR Part 820, ISO 14971, ISO 13485).
Strong track record of cross-functional collaboration with R&D, Device Development, Regulatory Affairs, and Manufacturing.
Experience leading continuous improvement initiatives within QMS environments.
Excellent communication and stakeholder management skills, with the ability to influence at senior levels.

Nice To Haves

Previous involvement in building or transforming device development quality strategies is an advantage.

Responsibilities

The Head DevQA Drug Delivery Systems is responsible for the deployment and execution of the Quality and Compliance strategy incl. tools related to Drug Delivery Systems regulations to ensure uninterrupted development and subsequent supply of products.
Provides Quality governance in compliance with national and international GxP device regulations and internal design control standards as well with applicable quality requirements.
Acts as a consultant for Life Cycle Management activities for already commercialized combination products. Therefore, is part of the respective network and cross-functional Medical Device Boards to ensure alignment in the implementation of the Medical Device Quality strategy for Sandoz E2E.
Owns and manages together with the DevQA team quality related problems/ matters for the assigned Drug Delivery System product portfolio to ensure they are resolved consistently and in accordance with Sandoz standards and policies.
Supports inspections and audits at development sites and supports regulatory inspections of manufacturing sites involved in Drug Delivery System manufacturing, testing, and assembly as needed.
Accountable for the escalation of Quality & Compliance issues associated with Drug Delivery Systems to Management in accordance with Sandoz requirements and supports the implementation of remediation actions in a timely and robust manner.
Responsible for product assessments, Medical Device Reporting and recall activities per the Sandoz standards and policies.
Manages communication and interfaces with external contacts were appropriate: Industry and Health Authorities. External interaction with national and international regulatory bodies (e.g. European Medicines Agency (EMA), Food and Drug Administration (FDA) and Notified Bodies (NBs) mainly require interpretation of complex information; internal interactions require negotiation with, and persuasion of, function leadership and site management teams.
Participates in external working groups or standard setting organizations to influence regulatory and/or technical requirement definition affecting Drug Delivery Systems.
Leads, actively engages in, and supports Quality programs as needed.
Supports and ensures compliance for due diligence and integration projects for Drug Delivery Systems.
Collaborates to ensures GxP compliance of Drug Delivery Systems of alliance projects.
Identifies resource and skill gaps, subsequently- Recruits staff as required and Supports the team members in their personal development and in determining training needs
Strives to consistently uphold Sandoz´s core values