Assoc Dir Quality Project & Sys

 

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

 

Assoc Dir Quality Project & Sys 

 

Manages and coordinates global activities related to Quality Systems. Participates in cross-departmental and cross-site discussions/decisions pertaining to Quality Systems.

NOTE: Quality Systems include Quality Roles & Responsibilities, Management Responsibilities, Change Management, CAPA Management, Deviation Management, Document Management and Data Integrity, Procedure Management, Risk Management, Supplier Management, and Training Management.

 

YOUR TASKS AND RESPONSIBILITIES

 

The primary responsibilities of this role, Associate Director Quality Project & Systems, are to:

• Plans and conducts routine Quality Systems audits (self-inspections) across Bayer CH GxP-regulated functions. QA findings will be presented to involved staff and, if appropriate, to the responsible individuals at suppliers. Collaborates with functional area SMEs and recommends corrective action/preventive actions (CAPAs) for compliance concerns. Reviews resolution of compliance concerns and approves implementation of CAPAs;
• Plans, conducts, and oversees audits/inspections with minimal supervision.
• Provides oversight to Technical Transfer teams to ensure changes are appropriately captured, discussed, and approved;
• Independently reviews and approves GxP-regulated SOPs from department outside of CH R&D Quality as well as non-GxP SOPs from other departments within CH RMSQC (e.g., Regulatory, Medical Affairs, etc.).  Applies Quality Systems knowledge to ensure SOPs are a right fit for functional areas;
• Accepts assignments to conduct additional special projects with minimal supervision and participates on various global departmental committees, as required, to increase professional development. Communicates status to his/her management;
• Coordinates with Site, Project, and Technology Transfer colleagues to ensure meaningful metrics and trends are captured and reported quarterly;
• Collaborates with Global Quality to ensure that meaningful trends are developed and reported;
• Participates as support during GxP compliance inspections conducted by external sources (i.e. regulatory agencies) at Bayer CH or its suppliers, as applicable

 

WHO YOU ARE

 

Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

• Education in life-sciences;
• Practical experience in the areas of Quality Control, Quality Assurance and / or Manufacturing in the Pharmaceutical/Food Industries;
• Knowledge of international regulations and ICH requirements related to innovation and transfer of innovation products – cosmetics, food, nutritional, medicinal, me