Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change
QA Systems Leads
Job Tasks & Responsibilities:
Responsible for management of compliance activities in accordance with Bayer policies, standards, procedures and Global cGMPs. Lead Quality System team to establish, realize and monitor Quality System elements to ensure Quality and Regulatory Compliance across EM . The QA Systems Team Lead is receiving guidance and management direction from the Heads of Quality EM A&S and EM B&P
Provide effective leadership including:
selecting key personnel and motivating members of the functional area
assisting with Performance Calibration/Talent Pool Management
individual goal setting/performance reviews
managing the development of employees, training and development
supporting managers in team activities and Transition Workshops
supporting workforce diversity, quality and safety and supporting supervisors/managers in individual/department/business objectives
Leadership and People Management:
Create an environment of strong team spirit, timely and effective communications, sense of urgency and high motivation, and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities
Accountable for overall budget and financial performance of the Compliance, Quality Systems function
Technical And Functional:
Deputize QA Heads and FvP and act as a liaison and SME to present Quality Systems and compliance practices to Health Authorities and regulatory agencies
Develop strategies and plans for Compliance, Quality Systems for site in collaboration with senior management and lead the annual planning and updating of the Site Master File and Quality Plan
Review and approve all relevant Compliance, Quality Systems documentation related to field of expertise
Provide expert interpretation and application of regulatory guidelines to ensure operations, facilities and documentation meet Bayer standards and regulatory requirements
Direct staff to ensure that Quality Systems are maintained in compliance with Health Authorities, regulatory agencies, current Good Manufacturing Practices (cGMPs) and Bayer policies and procedures
Interface with Affiliates to maintain import licenses, support local Business Operations Functions to maintain and keep the necessary Wholesaler and Distribution Licenses
Job Requirements:
Bachelor’s degree or higher in science or equivalent is required; Biology, Chemistry, Pharmacy preferred, Graduate or higher-level Degree is preferred
Experience 10 or more years work experience in the pharmaceutical or related industry
At least 3 or more years of people management experience
Expert knowledge of Quality System principles, practices and standards for the pharmaceutical industry
Expert knowledge of cGMP relevant to the pharmaceutical industry; knowledge of the local and international GMP Regulations
Expert knowledge with audit or inspection management
Excellent communication skills including verbal, written and proven ability to influence.
Organizational agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence as well as trust of stakeholders.
Ability to interact effectively with Health Authorities and various Bayer stakeholders
Ability to effectively lead in a matrix environment
Proven ability to create a vision and motivate others to achieve that vision
Ability to make difficult, robust, rationalized and timely decisions balancing the totality of available data and risk
Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, enable trust, influence key stakeholders, cooperate as a team leader or team member, share information and deliver results with a team
Fluent in English is a must. Any other languages are a plus
Location:
Basel || Germany : Berlin : Berlin || Germany : North Rhine Westfalia : Leverkusen || Switzerland : Basel-City : Basel
Division:
Pharmaceuticals
Reference Code:
421032