Junior EM Quality Assurance Manager

Responsibilities:

Responsible for QA management and QA oversight of processes and products ofthe assigned portfolio including quality and regulatory requirements, prioritization, problem solving and escalation to Sr. Management, while assuring/ monitoring the quality performance of third-party contractors by tracking respective quality KPIs.
Designated QA key contact to the assigned third-party contractors thus holds expert knowledge for processes and products of assigned portfolio.
Interacts directly with third-party contractors and acts as quality interface towards other PS functions.
Responsible for QAA management including negotiations and disputes.
Manages teams across functions to provide highly scientific evaluation of issues, including approval of deviations, changes, quality documentation etc, intended to mitigate quality and compliance risk while maintaining product supply. Supports/manages Q-topics related to product launches/transfers with regards to quality requirements and their implementation.
Maintains awareness of current GMP trends and manufacturing processes and supports continuous improvement of the product quality.
Assures regulatory and cGMP compliance with approved dossiers and provides support for regulatory agency inspections and requests.

Important for us:

Master Degree in Pharmacy/ Biology/ Chemistry/ Biotechnology or similar discipline
2-3 years of relevant experience in Quality Assurance in pharmaceutical manufacturing.

Special Skill/Knowledge:

Good expertise in Quality Assurance in Pharmaceutical/ Biotech required with advanced knowledge and experience in subject matter areas as Production (e.g. Solids, Steriles, API, medical devices), QC/Chemical/ Regulatory;
Experience in oversight of contract manufacturing is preferred;
Broad cGMP experience and knowledge, QA/QC and regulatory compliance, ISO- medical device regulations (US and other international agencies);
Qualification or expertise in GMP/ISO Audits;
Stand for Bayer Quality standards towards CMO and shows courage in difficult situations;
Good leadership, Drive results and motivate others to achieve corporate, site, and departmental objectives;
Must be able to make tough decisions under pressure;
Communication skills with a collaborative style;
Diligent, thorough and solution oriented
Ability to effectively manage multiple, complex priorities.
Proficiency in English.

We offer: