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 Incidents Lead

Your tasks and responsibilities

  • 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
  • Directs the management and oversight of discrepancies in bulk, intermediates, drug product, and quality control, and complaints and assures timely investigations, resolution of issues and implementation of corrective/preventive measures using scientific principles, root cause analysis and compliance minded corrective and preventative actions related to contract manufacturing
  • Uses resources across sites and across departments to achieve strategic objectives. Leads teams to provide highly scientific evaluation of issues intended to mitigate business and compliance risk while maintaining product supply of biopharmaceutical product with regard to strength, purity, and potency
  • Prepares SOPs and investigation documents; tracking and trending analysis and KPI’s relevant to business process
  • Accountable for resolving production discrepancies as related to product release, which must take into account all manufacturing processes, quality testing and customer requirements. Must use scientific judgment to ask key questions during investigations intended to identify root cause of issues. Requires ability think calmly under pressure and to influence team members to arrive at decisions which may be difficult or unpopular
  • Maintains awareness of current GMP trends and manufacturing processes and supports continuous improvement within the Quality Unit
  • Provides support for regulatory agency inspections and requests
  • Provides expert opinion related product safety taking into account related production discrepancies, status of related change control and quality testing data (incl. data trending of critical process parameters and critical quality attributes)

 

Job Requirements:

  • Master or PhD in a scientific discipline
  • Minimum of 10 years of Pharmaceutical experience and 2 years of management experience
  • Advanced knowledge and experience in biopharmaceutical subject matter areas including: Manufacturing of bulk, intermediates and final containers; Product disposition and release; Discrepancy management; Product inspection and labeling; Aseptic processing; Environmental monitoring; Contract manufacturing
  • Broad cGMP experience and knowledge, QA/QCand regulatory compliance (US and other international agencies)
  • Ability to streamline business processes to maximize efficiencies to resolve discrepancies and trending issues. Must be able to make tough decisions under pressure and be able to adapt to changes in organization structure
  • Strong leadership and interpersonal skills
  • Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives
  • Excellent communication skills, good presentation and influencing skills
  • Ability to interact and gain the support of senior management
  • Demonstrated expertise in Lean and 6 Sigma. Green/Black belt Certification is an advantage

  • Certified GxP Lead Investigator is preferable

  • English is a must, any other additional languages is a plus

 

#LI-CH

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: Switzerland
Location: Basel
Functional Area:
Entry Level: