Please refer to topjobs.ch in your application
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.
Head Quality Assurance Pharma/ Biotech Basel (m/f)
Establish, implement and verify QA standards for all Biotech products
sourced from contract manufacturing partners; determine disposition
of deviations and complaints in line with Bayer and PS Biotech quality
standards; represent Contract Manufacturing QA on the Global Quality
Define and implement quality management standards and processes
within the CM Biotech team (SOP system, training, Compliance
Management System, Change Management, deviations, CAPA etc)
and assures compliance through self-inspections and internal audits.
Supports supplier audits. Responsible for KPI and monthly reports to
Define and approve all contracts manufacturing quality related
activities, processes and structures throughout the global product
supply networks of Biotech products with non-PS Biotech Bayer sites
and external production sites; align QA activities globally within PS
Biotech and with Contract Manufacturers; evaluates and approves
product changes using Change Management tools; works with
contract manufacturers to ensure manufacturing deviations are
investigated, root cause analysis is complete and CAPAs are closed in
a timely manner for all products within PS BT contract manufacturing.
Provide quality requirements and standards to all Operations Teams
and product development teams, represent voice of Quality and
Compliance in all product and process related decisions to assure
quality and compliance for PS Biotech Contract Manufacturing.
Leads global interdisciplinary project teams with representatives from
Bayer manufacturing sites and external suppliers to define, modify and
improves Quality Testing and Quality Assurance of CM Biotech
products; coordinate and approve all QC testing method transfers to
production sites and sales organizations world-wide.
Lead and organize assessments of current Biotech product licenses
and implements the TRD system for all Biotech products; review and
approve all regulatory submissions to improve and assure regulatory
Oversee external audits (regulatory authorities & customer audits) for
Biotech products at internal and external production sites, escorting
auditors; initiate and lead supplier audits for raw materials,
intermediates and medical devices.
May represent QA Biotech in due diligences; negotiate QA
agreements with external suppliers and resolve disputes.
Provide effective leadership to CM Biotech Quality Function including:
development and implementing objectives and business strategies;
selecting key personnel and motivating members of the functional
area; challenging employees to develop as leaders while serving as a
role model and mentor; assisting with Performance Calibration/Talent
Pool Management/Succession Planning; individual goal
setting/performance reviews; training and development; supporting
workforce diversity, quality and safety and supporting
supervisors/managers in management of their employees/department
which support achievement of individual/department/business